Febrile Neutropenia | Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO
Febrile Neutropenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation; 2. High-risk neutropenia (Absolute neutrophil count (ANC) <0.5x109/L which is expected to last longer than 7 days); 3. Fever (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); 4. Age 18 years or older; 5. Written informed consent. Exclusion Criteria: 1. Contraindications to use of imipenem-cilastatin or meropenem such as allergy, previous severe side-effects or previous microbiological cultures with carbapenem-resistant microorganism(s). 2. Corticosteroid use ≥10 mg per day prednisolone or equivalent during the previous 7 days. 3. Clinically or microbiologically documented infection. 4. Symptoms of septic shock (systolic blood pressure <90 mm Hg unresponsive to fluid resuscitation and/or oliguria (urine production <500mL/day). 5. Previous enrollment in this study during the same episode of neutropenia. 6. Any critical illness for which Intensive Care Unit treatment is required. 7. Legal incompetency
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Discontinuation of imipenem-cilastatin or meropenemDiscontinuation of imipenem-cilastatin or meropenem after 3x24 hours irrespective of presence of fever.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Short treatmentDiscontinuation of imipenem-cilastatin or meropenem after 3x24 hours irrespective of presence of fever.
Extended treatmentExtended 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 <37,5°C) for at least five consecutive days or until resolution of neutropenia (ANC > 0,5 x10^9/L), whichever comes first.
Start Date: December 2014
Completed Date: April 2017
Phase: Phase 4
Primary Outcome: The percentage of patients with failed treatment
Secondary Outcome: All-cause mortality.
Study sponsors, principal investigator, and references
Principal Investigator: Jeroen JWM Janssen, MD, PhD
Lead Sponsor: VU University Medical Center
Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development