Short versus extended antibiotic treatment for fever during low white blood cell counts in hematology patients with fever of unknown origin.

Phase 1

• Conditions: Febrile neutropenia; MedDRA version: 19.1Level: PTClassification code 10063581Term: Stem cell transplantSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 19.1Level: LLTClassification code 10002969Term: Aplastic anemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 19.1Level: LLTClassification code 10003999Term: BacteremiaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.1Level: LLTClassification code 10007810Term: Catheter related infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.1Level: LLTClassification code 10028566Term: MyelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1Level: LLTClassification code 10062957Term: Catheter bacteraemiaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.1Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1Level: PTClassification code 10056520Term: Catheter site infectionSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2014-001546-25-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-19
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 days 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 clinical trial of medicinal product
• Study Design: Not specified