Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial.

Phase 4

Completed

• Conditions: febrile neutropenia; 10018865; 10004018

• Registration Number: NL-OMON47609
• Lead Sponsor: VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 276

Inclusion Criteria

1.Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;;2.High-risk neutropenia;;3.Fever;;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

Study & Design

• Study Type: Interventional
• Study Design: Not specified