Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Hematologic Neoplasms

Communicable Diseases

Sepsis

Toxemia

Hematologic Diseases

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Anti-Infective Agents, Local

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

hematological malignancy patients with positive blood culture

During the febrile episode, two blood samples per patient will draw from two separate sites including central venous catheter if present and directly injected to Bact/Alert® bottles and incubated in Bact/ALERT system instrument (bioMérieux Diagnostics, Lyon, France).

A-Identification of microorganisms including:

1. Isolation of microorganisms:
2. Blood culture samples with positive signals will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates.

B-Identification of the bacterial organism

Pure colonies of isolated microorganisms were identified by:

Morphology on agar,Gram stain film was made from the growth to identify morphology of the organism ,Biochemical tests

C-For fungi isolate the following will perform:

1. Microscopic examination of Lactophenol cotton blue (LCB) wet mounts.
2. Culture on Brilliance Candida differential agar

blood culture

isolation of microbes from positive blood culture and anti fungal susceptibility testing or antibiotic susceptibility testing according to isolated microbes by disc diffusion method and Vitek2

Anti fungal susceptibility testing or antibiotic susceptibility testing

The VITEK 2 is an automated microbial identification system that utilizing growth-based technology. With its colorimetric reagent cards, the VITEK 2 offers a state of the art technology platform for phenotypic identification methods.

phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France)

FilmArray blood culture identification (BCID) is automated multiplex PCR assay, the FilmArray blood culture identification which directly identifies common pathogens, including 7 genera/ species of Gram-positive bacteria, 10 genera/species of Gram-negative bacteria, and 5 species of Candida (as well as 3 resistance determinants) in the positive blood culture bottles. The assay requires about 2 min of hands-on sample processing time and 1 h of instrument time (which includes DNA isolation, amplification, and detection).

Identification of the isolated organism by multiplex PCR

Mohamed Z Abo krisha, professor

* To identify the common bacterial and fungal species causing fungemia and bacteremia in hematological malignancies.
* To identify sensitivity pattern for causative microbes.
* Compare culture on ordinary media with Vitek2 (automated microbial identification system) and multiplex polymerase chain reaction (PCR )

Sepsis is a global health problem and an estimated 17 million cases of sepsis occur each year in the world .The early initiation of appropriate antibiotic therapy is determinant for the prognosis and survival of patients with bloodstream infections . Infections in patients suffering from hematological malignancies are a frequent problem, leading to higher mortality and morbidity, increased costs of health care and prolonged duration of hospitalization. Common among these infections are those involving the bloodstream. In febrile neutropenic patients, the attack rate of bloodstream infection was reported to be between 11 and 38% . Hematological malignancies by themselves or by their therapeutic strategies, put patients at risk for infections. Wide use of antibiotics and prophylactic agents in such patients has led to the development of resistance. The general term fungemia describes the presence of a fungal species in the blood while term bacteremia describes the presence of bacterial species in the blood A positive culture may indicate a widespread infection or commonly, the infection of an intravenous catheter .Fungal microbes are abundant in nature and are frequent colonizers on human mucosal surfaces. However, under conditions of impaired immune responses or a break in host barriers, fungi are able to invade normally sterile areas of the human body, where they can cause severe infections that are difficult to recognize and treat and are often ultimately lethal .Indeed, recent epidemiological data show that invasive fungal infections (IFIs) are frequently encountered in clinical practice, with the most common offenders, being Candida spp. and Aspergillus spp. In order to effectively eliminate these infections, early diagnosis and species identification are of paramount importance. Traditional diagnostic methods such as blood culture is still considered the gold standard .Indeed ,novel molecular and non molecular techniques have been developed and currently under clinical evaluation . The VITEK 2 is an automated microbial identification system that utilizing growth-based technology. With its colorimetric reagent cards, the VITEK 2 offers a state of the art technology platform for phenotypic identification methods. The application of the multiplex polymerase chain reaction PCR method in the diagnosis of bloodstream infections is designed to reduce the time for identification of the microorganisms grown from the positive samples to 24-48 hours, as pathogens are identified directly from a positive blood sample

Detection of Bloodstream Pathogens in Hematological Malignancies

Examine blood culture to diagnose different species of pathogens including bacteria and fungi responsible for bloodstream infection in hematological malignancies patients.

performance of antimicrobial susceptibility testing (anti fungal susceptibility testing or antibiotic susceptibility testing )of significant bacterial isolates. The goals of testing are to detect possible drug resistance in common pathogens and to assure susceptibility to drugs of choice for particular infections.

prevalence of both bacteremia and fungemia in hematological malignancies using blood culture

The hypothesis is that faster identification will lead to faster action.

Faster treatment is associated with reduced mortality

Compare different methods for rapid identification of blood culture positive results including Vitek2 (BioMerieux,France) and multiplex PCR

Assiut University

Principle investigator

Nutritional and Metabolic Diseases

Digestive System Diseases

Malnutrition

Ileus

Nutrition Disorders

Pharmaceutical Solutions

Herbal and Botanical

Soybean oil, phospholipid emulsion

Fat Emulsions, Intravenous

Parenteral Nutrition Solutions

Soy Bean

Olive

Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital

Patients that are randomized to receive ClinOleic as a lipid emulsion in their PN, instead of Intralipid. ClinOleic is approved by Health Canada. The amount of calories from the lipid emulsion will be equivalent in the standard of care group and in the ClinOleic group.

Intralipid

ClinOleic

Johane P Allard, MD, FRCPC

Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding. It is important to indicate it in the appropriate setting because it's not free of complications and is a costly treatment. Some of the complications are: elevated blood sugar or lipids, elevated liver function tests, infection of the catheter or device used to administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals to evaluate the quality of intravenous nutrition administered to hospitalized patients in terms of: assessing indications, prescription, complications, clinical results and costs. The objective of this study is to determine if intravenous nutrition prescribed in hospitalized patients is indicated following existing guidelines in terms of timing of nutrition support, prescription, monitoring and whether it is associated with complications. In addition, length of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).

Until recently, Intralipid, a soybean oil-based lipid emulsion, has been the only available lipid for intravenous use in Canada. In 2010, ClinOleic, a new, predominantly olive oil based emulsion, has been approved by Health Canada as an alternative lipid.

There is an increasing need for hospitals to do quality-assurance studies for in-patient parenteral nutrition (PN) to assess indications, PN prescription, complications, clinical outcomes and costs. The only in-patient population that is well studied is the intensive care unit (ICU) population. Several meta-analyses showed that PN was associated with higher infection rate, longer length of stay and higher mortality when compared with enteral nutrition. Results from these and other studies were the basis for the Canadian ICU Guidelines.

The aim of this study is to determine if PN prescribed in in-patients is indicated, appropriately following existing guidelines in terms of timing of nutrition support, prescription and monitoring and, whether it is associated with complications. In addition, clinical outcomes such as length of stay and mortality will be assessed. Also, we will evaluate metabolic, nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion compared to those of patients receiving olive oil-based lipid emulsion.

Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions

prealbumin is an hepatic protein that is used in the diagnosis of malnutrition. It has a short half-life so any changes in nutritional status can rapidly be represented by prealbumin levels.

Length of stay in the hospital and ICU will be recorded. We will record how many days it took,since admission to the hospital, for the patient to be discharged. This is an expected average of 4 weeks of length of stay.

We will follow the patients from the day of admission until the day of discharge and record the mortality, if applicable. The expected average of hospital stay is 4 weeks.

We will measure weight before, at day 10 and after PN to calculate the BMI at this different points. The last day of PN is whenever the patient is taken off PN. This can vary considerably from patient to patient.

we will record the infections the patients develop during PN until one week after PN

We will measure hand grip strength at baseline (day0) and at day 10 of PN. This is a test that measures the strength of the hand and forearm muscles and is often used as a general test of strength

is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support

we will record antibiotic days from the start of PN until one week after PN is discontinued

hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN

Red blood cell fatty acid composition, particularly the essential fatty acids (linoleic acid and alpha-linolenic acid) will be measured to assess presence/absence of essential fatty acid deficiency

Johane Allard

Professor of Medicine, Director-Division of Gastroenterology

Rare Diseases

Leukemia

Bacteremia

Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Leukocyte Disorders

Granulocytopenia

Acute Graft Versus Host Disease

Fluoroquinolones

Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis.

Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis.

Observational study with no intervention.

No intervention.

Michael Satlin

Vance G Fowler, MD

This is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (HCT) recipients are colonized with fluoroquinolone-resistant Enterobacterales (FQRE) and the clinical impact of FQRE colonization.

This is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (HCT) recipients are colonized with fluoroquinolone-resistant Enterobacterales (FQRE) and the clinical impact of FQRE colonization.

The investigator will collect perianal swabs from patients receiving induction chemotherapy for acute leukemia or undergoing hematopoietic stem cell transplantation (HCT), and who are receiving fluoroquinolone (FQ) prophylaxis. FQRE colonization will be assessed by culture, and the investigator will correlate FQRE colonization with the risk of Gram-negative bacteremia during neutropenia.

Population: 410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia.

Results of this study will be combined with a portion of subject data from an identically-designed R01-funded study of FQRE colonization. The combined data will be used for study analysis and reporting.

Perianal swabs are collected from subjects and only isolates are retained. Bloodstream infection isolates are retained.

Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies

Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)

Acquisition of FQRE and ESBL-E in patients not initially colonized with these organisms

Gram-negative BSI during the episode of neutropenia

Colonization with fluoroquinolone-resistant Enterobacterales (FQRE) and Extended-spectrum-beta-lactamase-producing Enterobacterales (ESBL-E) upon initiation of chemotherapy

Occurrence (Yes/No) of fever (≥38.0°C) during the episode of neutropenia.

Any BSI during the episode of neutropenia

Intensive care unit admission prior to recovery from neutropenia

90-day mortality from the collection of the first swab

Weill Medical College of Cornell University

National Institute of Allergy and Infectious Diseases (NIAID)

Duke University

Joshua Wolf, MBBS, BA

The majority of children and adolescents diagnosed with cancer will experience one or more episodes of fever or infection during their course of therapy. The most common microbiologically documented infection is bloodstream infection (BSI), which can be associated with severe sepsis or death. Current methods of diagnosis require a significant load of live bacteria in the blood making early detection difficult. Delayed diagnosis and delayed optimal therapy of BSIs are associated with increased morbidity and mortality.

This study seeks to identify whether next generation sequencing (NGS) of pathogens can identify patients with impending bloodstream infection. This would enable preemptive targeted therapy to replace antibacterial prophylaxis which often leads ot high-density broad-spectrum antibiotic exposure and contributes to subsequent development of antibiotic resistance.

PRIMARY OBJECTIVE:

* To estimate the sensitivity and specificity of next generation pathogen sequencing for prediction of bloodstream infection in children with cancer at high risk of infection.

Plasma samples collected but not required for clinical care (discarded samples) will be collected and stored. Results of NGS will be compared between patients who develop BSI immediately (within 72 hours) after sample collection, those who develop other infectious syndromes, and those who remain well. Clinical data describing baseline information about the patient and malignancy, antibiotic and chemotherapy exposure, microbiology testing, hematology results, and infection-related events will be collected prospectively from the electronic medical record.

An initial exploratory phase will examine approximately 50 participants to determine whether the effectiveness of predicting infections. The study may then enroll up to 200 participants to collection additional data for analysis.

Plasma samples collected but not required for clinical care will undergo next generation pathogen sequencing.

Next Generation Pathogen Sequencing for Prediction of Adverse Events

Prediction of Adverse Events in Children and Adolescents With Cancer at High Risk of Infection (PREDSEQ)

To estimate the sensitivity of next generation pathogen sequencing for prediction of BSI, the proportion of NGS-positive results in all positive BSI cultures will be given.

To estimate the specificity of next generation pathogen sequencing for prediction of BSI, the proportion of NGS-negative results in all negative BSI cultures will be given.

Karius, Inc.

St. Jude Children's Research Hospital

Gentamicins

Colistin

Fosfomycin

Fosfomycin-trometamol (3 g granules dissolved in 200 ml of water for oral administration every 72h) and colistin (2x106 IU oral solution dissolved in 50-100 ml of water given orally every 6 hours) and gentamicin (an 80 mg oral solution dissolved in 50-100 ml of water given orally every 6 hours) will be administered in a double-blind fashion for a total duration of 7 days (day 1-7). The placebo treatment will be identical in taste, consistency, colour and packaging. To include the oral cavity into the eradication regimen, all medications should be gargled for at least 10 seconds before being swallowed.

Placebo preparations of fosfomycin, gentamicin and colisitin, identical in taste, texture and color will be administered at the same rate as the active comparator medication.

ESBL eradication regimen

Placebo ESBL eradication

Maria J Vehreschild, MD

Rapid and rational health-care interventions are of great importance to efficiently combat the emergence of resistant and virulent bacteria. In recent years, spread of ESBL-E on a global level has been observed.

For ESBL-E, effective eradication regimens are not yet available. The current study therefore aims to assess a new approach to ESBL-E eradication. To avoid administration of the eradication regimen to patients at low risk of subsequent BSI with ESBL-E, the study population will be restricted to immunocompromised high-risk patients.

Bloodstream infections (BSI) with multi-drug resistant (MDR) bacteria such as extended- spectrum betalactamase producing Enterobacteriaceae (ESBL-E) are associated with significant morbidity and mortality, particularly in the immunocompromised patient. In recent years, rapid spread of ESBL-E on a global level has been observed. While guidelines on effective infection control and treatment measures are urgently needed, the required basis of evidence is yet to be generated. Particularly data from interventional trials is lacking.

From October 2011 to December 2012, a multicenter cohort study on ESBL-E colonization and infection in haematology/oncology patients has been conducted within the Deutsches Zentrum für Infektionsforschung (DZIF) and allowed for a detailed description of the epidemiology of ESBL-E in this patient population. Based on these results, the sample size calculations for this study were carried out.

Rapid and rational health-care interventions are of great importance to efficiently combat the emergence of resistant and virulent bacteria. In recent years, spread of ESBL-E on a global level has been observed.

In 2012, the KRINKO (Kommission für Krankenhaushygiene und Infektionsprävention) at the Robert Koch Institute in Berlin, German, published their new recommendations on the management of colonization and infection with Gram-negative MDR bacteria, including ESBL-E. In high-risk settings, e.g. haematology/oncology wards and intensive care units, contact isolation is recommended for all patients who are colonized or infected with ESBL-E. While recommendations of the KRINKO are not legally binding, many institutions are now integrating these suggestions into their standards of care, given the recent increase in the prevalence of ESBL-E. This development is putting a considerable strain on patients and treating physicians. Firstly, previous studies have demonstrated the negative impact of long-term isolation on the patients' frequency of contacts with health care workers, a decrease in scores for self-esteem and an increase in scores for anxiety and depression.Secondly, proper contact isolation requires treatment in a single room. Many hospitals are, however, not equipped with sufficient numbers of single rooms, to accommodate all patients carrying MDR bacteria. Apart from problems associated with contact isolation, immunocompromised patients who are colonized with ESBL-E are at an increased risk of subsequent bloodstream infections (BSI).

Medical care providers are used to be faced with similar problems when dealing with methicillin-resistant Staphylococcus aureus (MRSA). However, nowadays, eradication regimens offer the possibility to remove MRSA from the skin and mucosa of colonized patients, thus interrupting its further spread to a considerable extent. For ESBL-E, effective eradication regimens are not yet available. The current study therefore aims to assess a new approach to ESBL-E eradication. To avoid administration of the eradication regimen to patients at low risk of subsequent BSI with ESBL-E, the study population will be restricted to immunocompromised high-risk patients.

The human intestinal tract is known to be colonized by hundreds of different bacterial species and other microbes. Based on the experience with fecal microbiota therapy in the treatment of recurrent Clostridium difficile infections, it can be hypothesized that the intestinal microbiome may influence the success or failure of the present study intervention. Thus, at selected sites, a metagenomic analysis of the intestinal microbiome will be performed to explore possible associations between certain microbiome patterns and the successful eradication of ESBL-E.

There is an ongoing discussion on whether antibiotic regimens used for eradication and selective digestive tract decontamination (SDD) might lead to the emergence of multi-drug resistant bacteria.11 Emergence of resistance under long-term administration of SDD to ICU patients has been previously reported.12 However, a recently published meta-analysis, including 64 studies in ICUs, of which 47 were randomized controlled trials and 35 included data for the detection of antimicrobial resistance, no relation between the use of SDD and the development of antimicrobial resistance could be detected.13 Even without this information, the risk for emergence of resistance should be classified as very low, considering that patients will receive eradication treatment for the duration of only seven days. Nevertheless, the possible emergence of non-ESBL multi-drug resistant bacteria in the intestine will be assessed during the study intervention.

Concerning the choice of an antibiotic regimen with a high chance of effectively eradicating ESBL-E from the gut, data from previous studies has been taken into account. Most previous study concepts were based on the idea of SDD.14-16 SDD aims to eradicate abnormal aerobic gram-negative bacteria, while preserving anaerobic bacteria. In this setting, the problem of adverse events caused by systemic effects of the antibiotics used can be discarded. However, if only locally active antibiotics are used for achieving eradication, patients are less likely to clear concurrent ESBL-E colonization of the throat, skin and urinary bladder. These body sites may then serve as a source of intestinal re-colonization with ESBL-E. Therefore, the current pilot study uses a combination of a non-absorbable enterally administered antibiotic and a systemic antibiotic. To facilitate the choice of an optimum non-absorbable antibiotic, antimicrobial susceptibility testing of clinical isolates of ESBL-E from haematological high-risk patients was carried out at the University Hospital Cologne in 2012. Virtually no resistance towards colistin could be detected (data not published), such that colistin was chosen as the non-absorbable component. As previous studies have shown promising results for a combination of colistin and gentamicin, the latter was added to the eradication regimen. Concerning the choice of a systemically active antibiotic, promising data on the clinical efficacy of fosfomycin in ESBL-E infections and in the reduction of ESBL-E in the intestinal flora have been published. Given the additional convenience of an available oral formulation - a prerequisite not given for most other ESBL-E active treatments - fosfomycin was chosen for combination with oral colistin and gentamicin. For the treatment of urinary tract infections, oral fosfomycin is usually administered as a single dose of 3g. However, several studies have assessed treatment of complicated or chronic urinary tract infections with repetitive administrations of 3g fosfomycin.

Since a single dose may not suffice to reduce the intestinal ESBL-E burden below the limit of detection, a schedule of 3g p.o. every 72h was chosen for this study.

Controling Intestinal Colonization With Extended Spectrum ß-Lactamase Producing Enterobacteriaceae ESBL-E

Controling Intestinal Colonization of High Risk Patients With Extended Spectrum ß-Lactamase Producing Enterobacteriaceae (ESBL-E) - A Randomized Trial (CLEAR)

Short-term intestinal eradication, defined as a fecal sample , negative for ESBL-E on day 6+/-1 and day 11+/-2

Long-term intestinal eradication d28, defined as a fecal sample1, negative for ESBL-E on day 28+/-4

Long-term intestinal eradication d42, defined as a fecal sample1, negative for ESBL-E on day 42+/-4

Short-term non-intestinal eradication, defined as a combination of ESBL-E negative samples from urine and throat on day 6+/-1 and day 11+/-2

Long-term non-intestinal eradication d28, defined as a combination of ESBL-E negative samples from urine and throat on day 28+/-4

Long-term non-intestinal eradication d42, defined as a combination of ESBL-E negative samples from urine and throat on day 42+/-4

Emerging presence of non-ESBL multi-drug resistant bacteria in the intestine, defined as identification of vancomycin resistant Enterococci (VRE), carbapenem- resistant gram negative rods (4MRGN according to the KRINKO definition) or colistin-resistant enterobacteria (except Proteus and Serratia spp.) in a fecal sample on day 6+/-1, day 11+/-2, day 28+/-4 or day 42+/-4

Association between the intestinal microbiome pattern and the outcome of eradication on baseline, day 6+/-1, day 11+/-2, day 28+/-4 or day 42+/-4

Quantitative assessment of intestinal ESBL-E burden on baseline, day 6+/-1, day 11+/-2, day 28+/-4 or day 42+/-4

Rate of AE-related study drug discontinuations

Maria J.G.T. Vehreschild

Dr. med.

Cross Infection

Aspergillosis

Disease Attributes

Mycoses

Bacterial Infections

Bacterial Infections and Mycoses

Iatrogenic Disease

Oculocerebral Syndrome With Hypopigmentation

Arne Simon, MD

Udo Bode, MD

Roland Ammann, MD

Hans-Jürgen Lawas, MD

The Oncoped 2006 study implements a multicenter prospective surveillance module for nosocomial infections in pediatric cancer patients.

Type of study:

Prospective multicenter surveillance study referring to file data collected routinely during the management of infectious and thrombotic complications in high risk pediatric cancer patients.

Primary aims of the Oncoped 2006 Study

1. To describe the epidemiology of selected nosocomial infections in pediatric cancer patients as well on the unit level as in a reference database of cumulative data from a prospective multicenter surveillance perspective.
2. To allow the participating institution

   * to compare its own results with other centers and with the reference database (median and 75. percentile).
   * to reduce the incidence density of nosocomial infections and the incidence rate of catheter-associated infections in pediatric cancer patients.
3. To promote patient's safety by means of quality assurance and a reduction of nosocomial infections.
4. To describe objective outcome variables related to the documented NI events (mortality, duration of hospitalization, need for intensive care, need for surgical interventions)
5. To intensify the practical collaboration of the health care team with infection control personnel and infectious disease specialists in this clinical context.
6. To describe the distribution of bacterial pathogens of blood stream infections and to determine the sensitivity (minimal inhibitory concentration) of bacterial pathogens detected in blood cultures to first and second line antimicrobial agents in this high risk population with a standardized method (central reference laboratory).
7. To detect bacterial isolates with emerging types of antimicrobial resistance.
8. To describe the therapeutic use of antibacterial and antifungal agents in pediatric cancer patients related to nosocomial infections.
9. To describe the incidence and incidence density of invasive Aspergillosis in pediatric cancer patients.
10. To describe the clinical impact of common and emerging viral respiratory pathogens (RSV, Influenza, hMPV, hCoV, hBoV) in pediatric cancer patients with nosocomial lower respiratory tract infection (central reference laboratory for emerging viral pathogens).
11. What is the incidence and incidence rate (per 1000 catheter utilization days) of thrombotic events in pediatric cancer patients and in patients with hemophilia, who have a CVAD in use?
12. How many of the children with an event do have congenital risk factors (thrombophilia)?
13. What are the objective outcome parameters in this population considering antithrombotic treatment (at the discretion of the attending physicians)?

Surveillance for Nosocomial Infections in Pediatric Cancer Patients

Prospective Surveillance for Nosocomial Infections and Catheter-related Thrombotic Events in Pediatric Patients

University Hospital, Bonn

Arne Simon (MD, PhD)

Wounds and Injuries

Hyperthermia

Fever

Dermatologic Agents

Chlorhexidine

Chlorhexidine gluconate

Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.

Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.

Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.

3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV

Maria JG Vehreschild, Dr. med.

In neutropenic cancer patients, catheter-related bloodstream infections may cause severe infections and even death. To assess the prophylactic effect of a chlorhexidine coated catheter securement dressing on the incidence of catheter-related bloodstream infections, this open, randomized trial is being carried out. CHG iv Tegaderm securement dressing will be randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.

Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients

Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial

Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter

Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter

Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter

Overall incidence of catheter-related bloodstream infection (evaluated by definite, probable and proven criteria)

Overall catheter-related bloodstream infection-related severe sepsis (evaluated by definite, probable and proven criteria)

Overall catheter-related bloodstream infection-related mortality(evaluated by definite, probable and proven criteria)

Time to removal of central venous catheter

Time to central venous catheter-related blood stream infections

Rate of unplanned changes of the catheter securement dressing.

Tolerability/safety is defined as the number of toxicity-related study therapy discontinuations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection of Bloodstream Pathogens in Hematological Malignancies	NCT03896880	Bloodstream Inf...	blood culture Anti fungal sus... phenotypic iden... Identification ...	18 Years -	Assiut University
Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils	NCT01943409	Obstruction Cancer Ileus Malnutrition Surgery	Intralipid ClinOleic	18 Years -	University Health Network, Toronto
Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies	NCT04710212	Hematologic Mal... Leukemia, Acute Neutropenia Bloodstream Inf...	No intervention...	18 Years -	Duke University
Next Generation Pathogen Sequencing for Prediction of Adverse Events	NCT03226158	Bloodstream Inf...		- 24 Years	St. Jude Children's Research Hospital
Controling Intestinal Colonization With Extended Spectrum ß-Lactamase Producing Enterobacteriaceae ESBL-E	NCT01931592	Cancer	ESBL eradicatio... Placebo ESBL er...	18 Years -	University of Cologne
Surveillance for Nosocomial Infections in Pediatric Cancer Patients	NCT00843804	Nosocomial Infe... Bloodstream Inf... Invasive Asperg...		- 21 Years	University Hospital, Bonn
Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients	NCT01544686	Bloodstream Inf...	3M™ Tegaderm™ C...	18 Years -	University of Cologne
Controling Intestinal Colonization With Extended Spectrum ß-Lactamase Producing Enterobacteriaceae ESBL-E	NCT01931592	Cancer	ESBL eradicatio... Placebo ESBL er...	18 Years -	University of Cologne
Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia	NCT04910698	Bloodstream Inf... Acute Myeloid L... Febrile Neutrop...	Antibiotic	18 Years -	Poitiers University Hospital
Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients	NCT01544686	Bloodstream Inf...	3M™ Tegaderm™ C...	18 Years -	University of Cologne
Detection of Bloodstream Pathogens in Hematological Malignancies	NCT03896880	Bloodstream Inf...	blood culture Anti fungal sus... phenotypic iden... Identification ...	18 Years -	Assiut University
The Role of NK Cells to Detect Blood Infection in ALL.	NCT06160115	Acute Lymphobla... Bloodstream Inf...	Flow cytometry	0 Years - 17 Years	Assiut University

Spots Global Cancer Trial Database for bloodstream infection