Korte versus lange behandeling met een carbapenem voor onverklaarde koorts tijdens hoog risico neutropenie bij hematologische patiënten: een gerandomiseerde non-inferiority studie.
- Conditions
- Hematologic malignancyNeutropeniaNeutropenic feverUnexplained feverStem-cell transplantationChemotherapy
- Registration Number
- NL-OMON26213
- Lead Sponsor
- VU university medical center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 224
Inclusion Criteria
1. Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;
2. High-risk neutropenia;
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the percentage of patients with failed treatment. Treatment failure is defined as the occurrence of one of the following events after 3x24hours of treatment with a carbapenem. <br /> <br>The patient: <br /><br>1. Has fever at the first day of the end of the neutropenic episode (defined as the first day with neutrophil count >0.5*109/L). <br /><br>2. Has experienced recurrence of fever after more than 24 hours of defervescence. <br /><br>3. Is diagnosed with a clinically or microbiologically documented infection. <br /><br>4. Shows signs or symptoms of septic shock (systolic blood pressure <90mmHg unresponsive to fluid resuscitation and/or oliguria <5mL/kg/hour). <br /> <br>5. Dies between the start of the investigational treatment protocol and recovery of neutropenia. <br>
- Secondary Outcome Measures
Name Time Method