NL-OMON47609
Completed
Phase 4
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. - SHORT-trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- febrile neutropenia
- Sponsor
- VUmc
- Enrollment
- 276
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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