Neoplasms

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Wounds and Injuries

Behaviors and Mental Disorders

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Hematologic Neoplasms

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Fever of Unknown Origin

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Granulocytopenia

Anti-Infective Agents

All Drugs and Chemicals

Meropenem

Anti-Bacterial Agents

Antibiotics, Antitubercular

Imipenem

Cilastatin, Imipenem Drug Combination

Cilastatin

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Discontinuation of imipenem-cilastatin or meropenem after 3x24 hours irrespective of presence of fever.

Extended treatment with imipenem-cilastatin or meropenem for at least 6 more days. The treatment with a carbapenem will be continued until patients have been treated for at least 9x24 hours and have been afebrile (tympanic membrane temperature \<38.0°C) for at least five consecutive days or until resolution of neutropenia (ANC \> 0,5 x10\^9/L), whichever comes first.

Discontinuation of imipenem-cilastatin or meropenem

Jeroen JWM Janssen, MD, PhD

Michiel A van Agtmael, MD, PhD

Mark MH Kramer, Prof., MD

Sonja Zweegman, Prof.,MD

A multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.

Episodes of fever are very common in patients undergoing intensive chemotherapy treatment for malignant hematological disease. More than 80% of patients experience one or more episodes of fever after their first cycle of chemotherapy. Only 20-30% of these patients have a clinically documented focus and mostly include infections of skin, intestinal tract and lung, while at most 10-25% of these patients have microbiologically proven bacteremia during these episodes. Patients with malignant hematological diseases and intensive chemotherapy induced neutropenia are extremely prone to overwhelming bacterial infections. Therefore, empirical antibiotic treatment is initiated at the first occurrence of fever, even if no apparent cause for the fever is evident. Most protocols advice treatment with very broad-spectrum antibiotics, mostly anti-pseudomonal carbapenems or fourth generation anti-pseudomonal cephalosporins.

Prolonged continuation of treatment may induce bacterial resistance. In view of the possible emergence of bacterial resistance due to prolonged antibiotic administration, continuation until recovery of neutropenia is suboptimal because it is costly because of longer hospital admissions, higher antibiotics costs and more possible adverse reactions.

Recent observational data (Slobbe et al) has showed that in adult hematological patients with febrile neutropenia, discontinuation of empiric antibacterial therapy after three days can be safe if no infectious etiology can be found, even in cases with persistent fever. However no RCT has hitherto been performed to support this observational data.

This study compares the safety (non-inferiority) of short treatment (72 hours) versus extended treatment (at least 9 days) with an anti-pseudomonal carbapenem for hematology patients with unexplained high risk febrile neutropenia. We hypothesize that a more restrictive use of broad-spectrum antibiotic use of three days in unexplained fever in neutropenic hematology patients is non-inferior to the present extended use during at least 9 days which would lead to a more restrictive use of antibiotics and less multiresistant strains of bacteria, costs and hospitalization length in the future.

Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO

Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With Fever of Unknown Origin: a Randomized Multicenter Non-inferiority Trial.

Treatment failure is defined as the occurrence of one of the following events after 3x24 hours and before 9x24hours after treatment initiation with a carbapenem:

-A clinically or microbiologically documented carbapenem-sensitive infection; treatment.

Recurrence of fever after previous defervescence (tympanic temperature \<38.0 °C during 24 hours) which is not attributable to administration of a blood product or to a drug reaction.

o In case of clinical doubt whether the fever is of infectious etiology, the recurrence of fever will be considered as failure.

The occurrence of death, ARDS/respiratory insufficiency, septic shock (systolic blood pressure \<90 mmHg and oliguria \<500 mL/day) due to any cause.

Treatment strategy failure is defined as occurrence of any of the following events after 3x24hours of treatment with a carbapenem and until the end of the neutropenic episode:

1. Any clinically or microbiologically documented infection.
2. The recurrence of fever after previous defervescence during neutropenia.
3. Death, septic shock or ARDS/respiratory failure due to any cause
4. Adverse drug-related events due to a carbapenem requiring (temporary) interruption of treatment, including but not exclusively: liver and kidney dysfunction, convulsion and allergic reactions.
5. Unexpected re-admission within 30 days after discharge other than for planned chemotherapy or other elective treatment.
6. Antibiotic or antifungal treatment within 30days after discharge other than standard antibiotic prophylaxis.

Fever is defined as one single measured tympanic membrane temperature of \>38.5°C or a temperature of \>38.0°C during 2 subsequent measurements separated by at least 2 hours.

Defervescence is defined as three times a tympanic membrane temperature \<37.5 °C with a minimal measurement interval of at least 8 hours

ZonMw: The Netherlands Organisation for Health Research and Development

FondsNutsOhra

Amsterdam UMC, location VUmc

Imipenem: 1g q8h i.v. daily for 5 consecutive days before the onset of conditioning of allo-HSCT

Without antibacterial prophylaxis at the onset of condition of all-HSCT

Imipenem: A wide-spectre antibiotic from the carbapenem group Other name: Imipenem-cilastatin

Zhao Ke

Liu Qifa

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematologic malignancies. Bacterial infections remain a common complication of allo-HSCT, especially in the pre-engraftment phase. Pre-engraftment neutropenia typically lasts for up to 2 weeks in autologous HSCT but is considerably longer in allogeneic HSCT recipients who receive myeloablative conditioning regimens. This is a prospective, randomized, controlled, phase II/III clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with hematological malignancies before allo-HSCT. All patients aged above 14 years, diagnosed with hematological malignancies and ready to undergo allo-HSCT, no active infection within 3 weeks before allo-HSCT, with a normal CT scan-chest before entering the transplantation cabin and willing to participate in the trial will be enrolled.

Antibacterial Prophylaxis vs no Prophylaxis for Hematological Malignancies Patients Before Allo-HSCT

Antibacterial Prophylaxis With Imipenem vs no Prophylaxis for Hematological Malignancies Patients Before Allogenetic Hematopoietic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University

Prof.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO	NCT02149329	Febrile Neutrop... Hematological M...	Discontinuation...	18 Years -	Amsterdam UMC, location VUmc
Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO	NCT02149329	Febrile Neutrop... Hematological M...	Discontinuation...	18 Years -	Amsterdam UMC, location VUmc
Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO	NCT02149329	Febrile Neutrop... Hematological M...	Discontinuation...	18 Years -	Amsterdam UMC, location VUmc
Antibacterial Prophylaxis vs no Prophylaxis for Hematological Malignancies Patients Before Allo-HSCT	NCT03733340	Antibacterial P... Hematological M... Allogenetic Hem... Imipenem	Imipenem	14 Years -	Nanfang Hospital, Southern Medical University
Antibacterial Prophylaxis vs no Prophylaxis for Hematological Malignancies Patients Before Allo-HSCT	NCT03733340	Antibacterial P... Hematological M... Allogenetic Hem... Imipenem	Imipenem	14 Years -	Nanfang Hospital, Southern Medical University

Spots Global Cancer Trial Database for imipenem

Every month we try and update this database with for imipenem 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 imipenem

Every month we try and update this database with for imipenem 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 imipenem 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.