Infections

All Conditions

Heart and Blood Diseases

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Thrombosis

Hematologic Neoplasms

Communicable Diseases

Bacteremia

Catheter-Related Infections

Embolism

Embolism and Thrombosis

Vascular Diseases

Hematologic Diseases

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Sepsis

Toxemia

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Other Dietary Supplements

Heparin

Citric Acid

Sodium Citrate

Calcium heparin

Citrate

After each use, the central venous catheter lumen will be flushed with 10 ml 0.9% NaCl and then locked with heparin 5000 IU/ml(standard treatment)using a volume exactly equivalent to the internal volume noted on each catheter.

locking the central venous catheter with concentrated citrate after each use

when not in use CVCs are locked with heparin

heparin

when not in use the CVC is locked with concentrated citrate

concentrated citrate

Harry Schouten, MD

Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used.

The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.

Central venous catheter (CVC)-related thrombosis and infections are frequently occurring complications and may cause significant morbidity in patients with hematological malignancies. Interventions to decrease fibrin deposition have the potential to reduce CVC-related thrombosis and infections.

At present heparin is most often used as locking solution for central venous catheters in hematological patients despite a lack of evidence regarding the efficacy and safety. Trisodium citrate (TSC) had been shown to be an effective antimicrobial catheter locking in hemodialysis patients.

Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients

Concentrated Citrate Locking to Reduce the Incidence of Central Venous Catheter-related Infections and Thrombosis: a Randomized Phase III Study in a Hematological Patient Population

Patients will be followed from insertion of the central venous catheter till removal of the central venous catheter, an expected average of 30 days. The central venous catheter is seen daily and checked for thrombosis and infections when the patient is admitted on the ward. Discharged patients are seen at least weekly on the outpatients clinic and their central venous catheter is checked for thrombosis and infections. A standard ultrasound is made 30 days after insertion and within 24 hours after removal of the central venous catheter.

Dirinco B.V.

Maastricht University Medical Center

Wounds and Injuries

Hyperthermia

Fever

Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result.

Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology patients. A reliable predictor of bacteremia infections in pediatric oncology patients should decrease hospitalizations for fever and unnecessary antibiotic treatment.

In our study we will measure procalcitonin levels in pediatric oncology patients presenting with fever. We will measure procalcitonin at the time of admission which is part of our standard of care for febrile pediatric oncology admissions. For the purpose of our study, we will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We will examine procalcitonin levels at these three timepoints to determine if elevated procalcitonin levels predict bacteremia in pediatric oncology patients with and without neutropenia.

Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients-Pilot Study

Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients - Pilot Study

Procalcitonin will be measured at the time of admission (Zero hours) and at 12, at 24 hours from admission.

CureSearch for Children's Cancer

CAMC Health System

Rare Diseases

Neutropenia

Viremia

Fungemia

Granulocytopenia

Anti-Infective Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Blood sample taken for metagenomic sequencing at inclusion visit.

Metagenomic diagnosis (mNGS, DISQVER)

Maxime PICHON

Corinne LORRAIN

CORENTIN ORVAIN, MD

ANNE-MARIE COUTURIER, MD

NIELS MOYA, MD

ALBAN VILATTE, MD

The development of targeted therapies and intensive protocols in oncohaematology has improved the survival of patients with haematological malignancies. The increase in the number of patients treated and their life expectancy has been accompanied by an increase in the incidence of infectious complications secondary to the immunosuppression induced by these therapies.

Febrile neutropenia (NF) is a complication that occurs in approximately 10% to 15% of patients treated for solid tumours and up to 100% of patients treated for haematological malignancies, particularly after bone marrow and/or haematopoietic stem cell transplantation.

In 25% to 30% of cases, NF leads to serious complications. The vast majority of NF cases are caused by microbial infections (bacteria, viruses, fungi, parasites, etc.), which can progress to severe sepsis or septic shock if appropriate treatment is not initiated rapidly (introduction of anti-infective molecules and implementation of associated procedures). If no pathogen is identified during the management of the most severe patients, the prognosis is poor, with a mortality rate of 10%.

The performance of diagnostic strategies is therefore an important factor in improving the prognosis of these patients. To date, the reference diagnosis of microorganisms is based on blood cultures, blood Polymerase Chain Reaction (PCR), β-D-glucan and aspergillosis serology. Identifying the pathogens responsible for NF from a blood sample without an a priori hypothesis and in an optimised timeframe could allow earlier treatment of high-risk NF with implications for management (possible modification of antimicrobial and/or immunosuppressive treatment).

The aim of this study is to evaluate the performance of the mNGS-DISQVER® tool in diagnosing pathogenic microorganisms from blood samples collected from patients being managed for high-risk NF.

1. Clinical context

   The development of targeted therapies and intensive protocols in oncohaematology has improved the survival of patients with haematological malignancies. The increase in the number of patients treated and their life expectancy has been accompanied by an increased incidence of infectious complications secondary to the immunosuppression induced by these therapies.

   Chemotherapy-induced febrile neutropenia (NF) is a common and serious complication occurring in approximately 10% to 15% of patients treated for solid tumours and up to 100% of patients treated for haematological malignancies, particularly after bone marrow transplantation. Febrile neutropenia is defined as a combination of :
   * Neutropenia: neutrophil count \<500 g/L or \<1000 g/L (if \<500 g/L is expected within 48 hours)
   * Fever: \>38.5°C on a single occasion or \>38°C for more than one hour. NF is associated with high morbidity and mortality (25-30% of serious complications and 10% of mortality). Its occurrence includes the need for hospitalisation with broad-spectrum antibiotic therapy, delayed chemotherapy and loss of opportunity for the patient. In the USA, an episode of NF requiring hospitalisation is associated with an estimated health economic impact of $19,110. A recent study in France estimated the clinical and economic impact of hospitalisation for NF, in terms of number of patients hospitalised, number of stays, in-hospital mortality and average cost per stay, to be €5,333 for haemopathies.

   A significant proportion of NF cases are caused by microbial infections that can progress to septicaemia if probabilistic broad-spectrum antibiotic therapy is not administered within an hour. Furthermore, microbiological documentation remains essential to optimise antibiotic therapy, with blood culture as the reference test. However, this test is limited for a number of reasons: difficulties or slowness in culture, antibiotic treatment prior to sampling, or insufficient sample quantity. Despite the recommended minimum of 3 or 4 pairs of blood cultures, 70% of cases of febrile neutropenia are not microbiologically documented, making it impossible to adapt probabilistic broad-spectrum antibiotic therapy. Another limitation is the time required to obtain results: 6 to 24 hours are required to obtain a positive blood culture, plus another 18 to 24 hours for bacteria to grow on solid media, and another 18 to 24 hours for susceptibility testing (antibiotic susceptibility testing).

   The absence of an identified pathogen in the management of the most severe patients is associated with a poor prognosis, with a mortality rate of 10%. As a result, the performance and timeliness of diagnostic strategies are important factors in improving the prognosis of these patients. In this context, the development of high-throughput sequencing technologies has led to the development of new diagnostic approaches based on the detection of circulating DNA (lcDNA, e.g. used in antenatal screening for trisomy 21). Although more recently democratised, the concept of microbial cDNA is well established in the field of infectious diseases. This technology, based on a blood sample obtained by simple venipuncture, could offer patients with febrile neutropenia an improved diagnosis, particularly in the case of negative blood cultures, and an adjustment in their management.
2. Identification and description of the IVDD

The DISQVERⓇ device is CE-IVD marked according to the In Vitro Diagnostic Directive (IVDD) classification approved until May 2026. The assessment file for its marking according to In-Vitro Diagnostic Regulation (IVDR) is in progress.

DISQVER® is a digital analytical solution developed by Noscendo for the rapid identification of microorganisms in a patient's blood sample from free circulating DNA, without any a priori hypothesis.

The test is based on metagenomic Next Generation Sequencing "mNGS" to identify, without a priori assumptions, the genomic sequences of micro-organisms (bacteria, DNA viruses, fungi and parasites) potentially present in the patient's plasma sample. The genomic sequences identified are then compared with Noscendo's proprietary database of over 16,000 microbial genome sequences, including 1,500 pathogens.

A report detailing all relevant pathogens detected in the sample is provided within a few hours (access to a pseudonymised pdf report according to the laboratory's guidelines, including the micro-organisms found in the highest concentration and the most likely pathogen present).

Metagenomic Sequencing for the Identification of Pathogens in Febrile Neutropenic Patients

Evaluation of the Diagnostic Performance of the DISQVER® Metagenomic Sequencing Tool for the Identification of Pathogens in Febrile Neutropenic Haemato-oncology Patients

Based on the microorganisms identified by the conventional work-up and the mNGS-DISQVER® tool, an adjudication committee consisting of a microbiologist, an infectiologist and a haematologist, independent of the study, will assess the presence of at least one pathogen requiring appropriate management. The interpretation of the conventional work-up and that provided by the mNGS-DISQVER® tool will be blinded.

The intrinsic diagnostic capabilities will be assessed by the sensitivity/specificity of the new mNGS-DISQVER® test, with the classification resulting from the conventional work-up as the reference.

The Youden index, the positive and negative predictive values of the new mNGS-DISQVER® test (with conventional work-up as reference) and the proportions of concordant and discordant pairs between the new test and conventional work-up.

The differences between the percentages of patient management modalities (escalation, maintenance, de-escalation or discontinuation of anti-infective treatment) using the mNGS-DISQVER® tool versus the conventional work-up.

The mean time taken for conventional assessment, the prevalence of microorganisms diagnosed in routine care (independent of the adjudication committee) and the percentage distribution of anti-infective adjustments according to microorganisms diagnosed in routine care.

Noscendo

Poitiers University Hospital

Immune System Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hodgkin Disease

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

Reproductive Control Agents

Moxifloxacin

Norgestimate, ethinyl estradiol drug combination

Enzyme Inhibitors

moxifloxacin

placebo

Oliver A. Cornely, MD

This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.

Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.

Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.

Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells

Double-blind, Randomized, Mono-center, Placebo-controlled Pilot Study to Investigate the Efficacy and Safety of Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells

Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary.

With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant.

Absolute neutrophil count (ANC) recovered to \> 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever \>= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason

University of Cologne

Medical Director of the Center of Clinical Trials (ZKS)

The following AE have been documented in the trial but are not reported in this section unless as SAE:

Infections, already reported as outcome measures.

Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.

Placebo

Total

Age, Continuous

Sex: Female, Male

Height

Weight

Hodgkin's Disease

Solid Tumor

Underlying Disease

primary

primary progressive

relapsed

Status of Underlying Disease

Prof. Dr. Oliver A. Cornely

Incidence of Clinically Significant Bacteremia

bacteremia isolate: enterococcus faecalis

bacteremia isolate: escherichia coli

bacteremia isolate: klebsiella pneumoniae

bacteremia isolate: pseudomonas aeruginosa

bacteremia isolate: staphylococcus aureus

bacteremia isolate: staphylococcus epidermidis

bacteremia isolate: streptococcus species

clostridium difficile infection

mucositis

Type of Isolates and Infections

Time to Occurrence of Fever >= 38°C

recovery of absolute neutrophil count

maximum of 20 days of treatment

premature discontinuation: occurence of fever

premature discontinuation: antibiotic treatment

premature discontinuation: death

premature discontinuation: other adverse event

premature discontinuation: other reason

Reason for Discontinuation of Treatment

peri-anal abscess

pulmonary infiltrate

infection at venous catheter

herpes infection

candida infection

acute respiratory syndrome

atypical pneumonia

Type of Infection

Overall Survival

Overall Study

Pharmaceutical Solutions

Taurolidine

Tunneled central venous catheters locked with Taurolock

Tunneled central venous catheter locked with heparin

When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.

Taurolock

When not in use the childrens tunneled central venous catheters are locked with heparin

Henrik Schrøder, MD, Dr.med.

Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the number of CRBSI in children with cancer compared with children with heparin lock of their CVC.

The most frequent complications of long term TCVC are catheter related blood steam infections(CRBSI)often caused by microorganisms located in the biofilm formed on the inner surface of the TCVC after a short time. CRBSI may be lifethreatening, will need long term intravenous broad spectrum antibiotic therapy possibly combined with intraluminal antibiotic lock therapy. In spite of this CRBSI may often lead to the premature removal of the TCVC.

Several methods to prevent the occurrence of intraluminal microbial colonization have been investigated with no single method standing out as the optimal one.

There is a need for a simple and safe method of reducing the occurrence of CRBSI in immunocompromised children receiving chemotherapy for malignant diseases. Various catheter lock solutions in stead of using heparin have been investigated in experimental models. Taurolidine is a chemically modified amino acid with broad spectrum antimicrobial activity in vitro. It is claimed to prevent the formation of luminal biofilm in TCVCs in a CVC model and it has been demonstrated to eradicate infected CVC in a three reports with a total of 18 patients.

In a 24 months study of routine use of Taurolidine 1,25%/Sodium-Citrate 4% (TaurolockTM) a reduction of gram-positive CVC associated infections was demonstrated. The findings were not statistically significant due to relatively few patients.

There is a need of a larger study with more patients receiving Taurolock for locking the TCVC between use in order to test for a significant reduction of the occurrence of CRBSI. Furthermore there is a need for an in vivo demonstration of the reduction of biofilm formation in TCVCs locked with taurolock compared with TCVCs locked with heparin.

Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia

A Randomised Study of Taurolock for the Locking of Tunneled Central Venous Catheters in Children With Malignant Diseases.

Danish Child Cancer Foundation

TauroPharm

Aarhus University Hospital

MD, PhD

Rajesh V Lalla, DDS, Ph.D

Patients who are preparing to receive chemotherapy are asked to have their teeth cleaned before starting treatment as standard of care. This research study is being done to see if having dental cleaning increases the chances of bacteria from the mouth getting into the blood stream. It is also being done to see if these bacteria can cause blood stream infections in people who have a Central Venous Catheter (CVC),often called a "port" or a "PICC", placed for giving chemotherapy. It is a well-established fact that we introduce bacteria from the mouth into the bloodstream with activities of daily life including chewing, flossing and brushing teeth. This introduction of bacteria into the blood stream may cause bacteria to stick to the central venous catheter and serve as a source of infection when the immune system is weakened by cancer. The purpose of this research study is to see if we can find bacteria from mouth in blood that is drawn through the CVC, during, and after a dental cleaning procedure. This way, we will be able to assess whether or not this is a potential health risk to cancer patients.

Dental Study in Cancer Patients With Central Venous Catheters

Pilot Study on Transient Bacteremia and Blood Stream Infections After Invasive Dental Procedures in Cancer Patients With Central Venous Catheters

Blood cultures drawn before dental cleaning, 20 minutes after starting procedure, 30 minutes after finishing the procedure and at 24 hours after starting the procedure. Records reviewed at one month and six months post procedure for bloodstream or central venous catheter infection.

Rajesh Lalla

Associate Professor, School of Dental Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients	NCT01820962	Hematological M... Bacteremia Thrombosis	heparin concentrated ci...	18 Years -	Maastricht University Medical Center
Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients-Pilot Study	NCT02417168	Cancer Bacteremia		- 17 Years	CAMC Health System
Metagenomic Sequencing for the Identification of Pathogens in Febrile Neutropenic Patients	NCT06075888	Immunodepressed...	Metagenomic dia...	18 Years -	Poitiers University Hospital
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells	NCT00398411	Hodgkin Disease Non-Hodgkin Lym... Multiple Myelom... Bacteremia	moxifloxacin placebo	18 Years - 75 Years	University of Cologne
Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia	NCT00735813	Bacteremia Neoplasms	Taurolock Heparin	- 17 Years	Aarhus University Hospital
Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia	NCT00735813	Bacteremia Neoplasms	Taurolock Heparin	- 17 Years	Aarhus University Hospital
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells	NCT00398411	Hodgkin Disease Non-Hodgkin Lym... Multiple Myelom... Bacteremia	moxifloxacin placebo	18 Years - 75 Years	University of Cologne
Dental Study in Cancer Patients With Central Venous Catheters	NCT00798330	Cancer		18 Years -	UConn Health
Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients	NCT01820962	Hematological M... Bacteremia Thrombosis	heparin concentrated ci...	18 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for bacteremia

Every month we try and update this database with for bacteremia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bacteremia

Every month we try and update this database with for bacteremia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bacteremia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.