CompletedPhase 4

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

Netherlands276 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;
. High-risk neutropenia (Absolute neutrophil count (ANC) \<0.5x109/L which is expected to last longer than 7 days);
. 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);
. Age 18 years or older;
. Written informed consent.

Exclusion criteria

. Contraindications to use of imipenem-cilastatin or meropenem such as allergy, previous severe side-effects or previous microbiological cultures with carbapenem-resistant microorganism(s).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The percentage of patients with failed treatment

Timeframe: Between randomization (at 3x24 hours) and before 9x24hours after treatment initiation)

Death/ARDS or Septic shock

Timeframe: From randomization until the end of neutropenia (neutrophil count >=0.5x10e9/L) up to 6 months after randomization.

Trial details

NCT IDNCT02149329

SponsorAmsterdam UMC, location VUmc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-05

View on ClinicalTrials.gov More Febrile Neutropenia trials