Overview

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

Status:
Completed
Trial end date:
2019-08-05
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
VU University Medical Center
Collaborators:
FondsNutsOhra
ZonMw: The Netherlands Organisation for Health Research and Development
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Cilastatin
Cilastatin, Imipenem Drug Combination
Imipenem
Meropenem
Thienamycins
Criteria
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 for more than 3
consecutive day 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