Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Wounds and Injuries

Rare Diseases

Hematologic Neoplasms

Communicable Diseases

Mycoses

Hyperthermia

Bacterial Infections

Neutropenia

Fever

Sepsis

Toxemia

Febrile Neutropenia

Fever of Unknown Origin

Disease Attributes

Body Temperature Changes

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Bacterial Infections and Mycoses

Granulocytopenia

The investigators retrospectively evaluated the efficacy of granulocyte transfusions as adjunctive treatment for severe infections in neutropenic fever unresponsive to antimicrobial therapy in hematological patients.

Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia

Efficacy of Granulocyte Transfusions for the Treatment of Severe Infections in Hematological Patients With Febrile Neutropenia

deaths due to infection occurred within 30 days after the last granulocyte transfusion

Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

Professor

Immune System Diseases

Recurrence

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Neoplasm Metastasis

Bacteremia

Diarrhea

Lymphoma

Acute Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Signs and Symptoms, Digestive

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Acute Leukemia of Ambiguous Lineage

Lymphosarcoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Levofloxacin

Ofloxacin

Anti-Bacterial Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.

Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.

levofloxacin

Sarah Alexander, MD

This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.

PRIMARY OBJECTIVES:

I. To determine whether levofloxacin given prophylactically during periods of neutropenia to patients being treated with chemotherapy for acute leukemia (AL) or undergoing hematopoietic stem cell transplantation (HSCT) will decrease the incidence of bacteremia.

SECONDARY OBJECTIVES:

I. To determine the effect of prophylactic levofloxacin on resistance patterns of bacterial isolates from all sterile site cultures, and the evolution of antimicrobial resistance from peri-rectal swab isolates of Enterobacteriaceae, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Streptococcus mitis.

II. To determine the effect of levofloxacin prophylaxis on total number of days of antibiotic administration (prophylactic, empiric, and treatment) in children undergoing therapy for AL or HSCT.

III. To determine whether levofloxacin prophylaxis reduces the incidence of fever with neutropenia, severe infection, and death from bacterial infection.

IV. To assess the safety of levofloxacin prophylaxis, with specific attention to musculoskeletal disorders including tendinopathy and tendon rupture.

V. To assess the impact of prophylactic levofloxacin on the incidence of Clostridium difficile-associated diarrhea (CDAD), and the incidence of microbiologically documented invasive fungal infections (IFI).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive levofloxacin orally (PO) or intravenously (IV) over 60-90 minutes once daily (QD) or twice daily (BID) beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.

ARM II: Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.

After completion of study therapy, patients are followed up for 1 year.

Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

A bacteremia incidence is defined as an occurrence of at least 1 episode of true (centrally reviewed) bacteremia among Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) patients.

Exposure to antibiotics was considered during the infection observation period(s) was defined a priori as follows: Gram positive agents = vancomycin, linezolid, daptomycin or quinupristin/dalfopristin; Aminoglycosides = amikacin, gentamicin or tobramycin; Third or fourth generation cephalosporins = cefepime, ceftazidime, ceftriaxone or cefotaxime; Empiric antibiotics for fever and neutropenia = imipenem, meropenem, cefepime, ceftazidime or piperacillin/tazobactam

Fever and febrile neutropenia defined as Absolute Neutrophil Count (ANC) \< 1000/mm3 with a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of \>= 38 degrees C (100.4 degrees F) for more than one hour.

Severe infection defined as any grade 4 or 5 CTCAE catheter-related infection, enterocolitis, lung infection, sepsis, small intestine infection and other infections or infestations

Musculoskeletal conditions included at least one occurrence of arthralgia, arthritis, gait abnormality or tendinopathy.

Clostridium Difficile Associated Disease (CDAD) is defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher.

National Cancer Institute (NCI)

Children's Oncology Group

Routine reporting includes all toxicities reported via AdEERs and all grade 4 \& higher non-hematologic Adverse Events

Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.

levofloxacin: Given PO or IV

Arm I (Levofloxacin)

Arm II (Standard of Care)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Canada

India

Mexico

Ireland

Region of Enrollment

Results Reporting Coordinator

Evaluable AL patients

Evaluable HSCT patients

All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.

Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms

Gram positive agents

Aminoglycosides

Third or fourth generation cephalosporins

Empiric antibiotics for fever and neutropenia

Comparison of the Percentage of Patients Having Antibiotic Exposures Between Arms

Comparison of the Percentage of Patients Having Incidence of Fever and Febrile Neutropenia Between Arms

Comparison of the Percentage of Patients Having Severe Infection Between Arms

Evaluable patients combined from both AL and HSCT cohorts were reported. Ineligible and withdrew of Consent prior to Tx were excluded.

Comparison of the Percentage of Patients That Died Due to Bacterial Infection Between Arms

Evaluable AL and HSCT Patients at Baseline

Evaluable AL and HSCT Patients at 2 Months

Evaluable AL and HSCT Patients at 12 Months

Evaluable patients who submitted musculoskeletal Case Record Form (CRF) combined from both Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) cohorts at enrollment. Ineligible and withdrew of Consent prior to treatment were excluded.

Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) Between Arms

Comparison of the Percentage of Patients Having Incidence of CDAD Between Arms

Overall Study

Staphylococcal Infections

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Gram-Positive Bacterial Infections

Dermatologic Agents

Chlorhexidine

Chlorhexidine gluconate

Anti-Infective Agents, Local

Disinfectants

Patients receive CHG cleansing with topical skin wipes QD for 90 days.

Patients receive control cleansing with topical skin wipes QD for 90 days.

Chlorhexidine Gluconate Skin Cleanser

Laboratory Biomarker Analysis

Mild Soap Skin Cleanser

Questionnaire Administration

Danielle M Zerr

This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control cleansing in preventing central line associated bloodstream infection and acquisition of multi-drug resistant organisms in younger patients with cancer or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream infections and bacterial infections associated with the central line.

PRIMARY OBJECTIVES:

I. To determine whether chlorhexidine gluconate (CHG) cleansing decreases central line associated bloodstream infection (CLABSI) in children with cancer or those receiving an allogeneic hematopoietic cell transplantation (HCT).

SECONDARY OBJECTIVES:

I. To determine whether CHG cleansing decreases acquisition of multi-drug resistant organisms (MDRO: vancomycin resistant enterococci \[VRE\], methicillin resistant Staphylococcus aureus \[MRSA\], etc.) in children with cancer or those receiving allogeneic HCT.

II. To determine whether CHG cleansing in children with cancer or those receiving allogeneic HCT is associated with cutaneous bacterial isolates with reduced susceptibility to CHG.

III. To determine whether CHG cleansing decreases positive blood cultures in children with cancer or those receiving allogeneic HCT.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive CHG cleansing with topical skin wipes once daily (QD) for 90 days.

ARM II: Patients receive control cleansing with topical skin wipes QD for 90 days.

Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant

Impact of Cleansing With Chlorhexidine Gluconate (CHG) on Reducing Central Line Associated Bloodstream Infection (CLABSI) and Acquisition of Multi-drug Resistant Organisms (MDRO) in Children With Cancer or Those Receiving Allogeneic Hematopoietic Cell Transplantation (HCT)

Rate of CLABSI per 1000 at-risk days. CLABSI outcome is defined according to the January 2015 Centers for Disease Control and Prevention (CDC) criteria. At risk days are defined as days with eligible central lines in place.

MDROs are defined as Staphylococcus aureus resistant to oxacillin, Enterococcus spp. resistant to vancomycin, Klebsiella pneumoniae or Escherichia coli non-susceptible (intermediate or resistant) to ceftriaxone, ceftazidime, cefepime or any carbapenem, and Pseudomonas aeruginosa or Acinetobacter baumannii resistant to any carbapenem or ceftazidime, and either an aminoglycoside or fluoroquinolone. Clostridium difficile infection (CDI) is included as an MDRO and is defined as a positive lab test for C. difficile and \> 3 unformed stools in \< 24 hours.

Susceptibility to CHG is defined by MIC cutoff that is cutaneous staphylococcal isolate isolated from a follow-up swab with CHG MIC \> 4 ug/mL in patient without a resistant staphylococcal isolate isolated from a baseline swab.

A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place.

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Patients receive CHG cleansing with topical skin wipes QD for 90 days.

Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing

Laboratory Biomarker Analysis: Correlative studies

Questionnaire Administration: Ancillary studies

Arm I (CHG Cleansing Wipe)

Patients receive control cleansing with topical skin wipes QD for 90 days.

Laboratory Biomarker Analysis: Correlative studies

Mild Soap Skin Cleanser: Given control cleansing

Questionnaire Administration: Ancillary studies

Arm II (Control)

3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses.

Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days

Percentage of Patients With Multi-drug Resistant Organisms (MDRO)

135 participants contributed a baseline and at least one follow-up swab and were included in this analysis

Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG)

3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analysis.

Rate of Bacteremia Per 1000 At-risk Days

Head and Neck Neoplasms

Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine

Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9%

4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio

4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %

NaCl 0.9 %

Franck JEGOUX, PH

Surgical site infections are an important health indicator for hospitals and a significant medico-economic issue.

The aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa.

The main objective is to reduce the number of patients with significant pathogenic bacterial colonization for pharyngeal mucosa at the end of the surgery. Oral flora is the same as the pharyngeal flora, so this suggests that the action of the oral mouthwash may also act in pharyngeal mucosa by buccopharyngeal communication.

Patients will be randomized into two groups :

* preoperative oral preparation with sodium chloride (NaCl) 0.9% (control group)
* preoperative oral preparation with chlorhexidine (experimental group)

A quantitative and qualitative analysis will be performed from samples collected during the surgery : before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5)

Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer

The percentage of patients with pharyngeal mucosa colonization will be determined from the sample collected on the mucosal scar just before the end of the surgery (T5)

The number of patients with a significant rate of pathogen germs will be determined from the sample collected after mouthwash (T1)

The type of germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))

The number of positive cultures of pathogen germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))

The kinetics of the number of CFU/ml will be determined from all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))

The number of CFU/ml of pathogens germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))

The change in the number of CFU/ml of pathogen germs will be assessed using the samples collected before (T2) and after intubation (T3)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia	NCT02544230	Neutropenia Fever Bacterial Infec... Fungal Infectio... Fever of Unknow... Hematological N... Sepsis		18 Years -	Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia	NCT02544230	Neutropenia Fever Bacterial Infec... Fungal Infectio... Fever of Unknow... Hematological N... Sepsis		18 Years -	Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation	NCT01371656	Acute Leukemias... Bacterial Infec... Diarrhea Fungal Infectio... Musculoskeletal... Neutropenia Recurrent Child... Recurrent Child... Secondary Acute... Untreated Child...	levofloxacin	6 Months - 21 Years	Children's Oncology Group
Granulocyte Transfusions in Hematological Patients With Febrile Neutropenia	NCT02544230	Neutropenia Fever Bacterial Infec... Fungal Infectio... Fever of Unknow... Hematological N... Sepsis		18 Years -	Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant	NCT01817075	Bacterial Infec... Benign Neoplasm Malignant Neopl... Methicillin-Res... Myeloid Neoplas... Recurrent Child... Recurrent Child...	Chlorhexidine G... Laboratory Biom... Mild Soap Skin ... Questionnaire A...	2 Months - 21 Years	Children's Oncology Group
Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer	NCT02753387	Bacterial Infec...	Chlorhexidine NaCl 0.9 %	18 Years -	Rennes University Hospital
Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant	NCT01817075	Bacterial Infec... Benign Neoplasm Malignant Neopl... Methicillin-Res... Myeloid Neoplas... Recurrent Child... Recurrent Child...	Chlorhexidine G... Laboratory Biom... Mild Soap Skin ... Questionnaire A...	2 Months - 21 Years	Children's Oncology Group

Spots Global Cancer Trial Database for bacterial infection