NCT04637464Completed
Early Termination of Empirical Antibiotics in Febrile Neutropenia in Children With Cancer
Early Termination of Empirical Antibiotics in High-risk Febrile Neutropenia in Children With Cancer: an Open-label, Randomised, Controlled Trial
Source: ClinicalTrials.gov · Last updated 9 Apr 2025
Brief summary (registry, in English)
The study is a nationwide, multicenter, open label, randomized controlled trial. A target population of 220 children in treatment for cancer with neutropenic fever and a neutrophil count below 0.5 × 10⁹ cells/L with expected duration for more than 7 days will be recruited during the first 48 hours of antibiotic treatment (24 months inclusion period). They will be randomized 1:1 as follows: * Experimental group: Discontinuation of antibiotics, despite neutrophil count below 0.5 × 10⁹ cells/L, after 48 hours of apyrexia and clinical stability * Control group: Discontinuation of antibiotics when neutrophil count is equal to or above 0.5 × 10⁹ cells/L and the child is afebrile and clinically stable (up to maximum of 14 days after apyrexia and clinical stability). Primary endpoint is the number of days without antibiotic treatment in 28 days after treatment initiation. Secondary endpoints are crude mortality, severe adverse events, days with relapsing fever, and alterations of the microbiome.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 93 (actual)
- First submitted
- 6 Nov 2020
- Start date
- 20 Nov 2020
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Kjeld Schmiegelow
- Diseases
- Childhood cancers
- NCT number
- NCT04637464
What you commit to
- Study type: Interventional
- Participants enrolled: 93
- From 20 Nov 2020 to the primary completion date, 31 Jan 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- obvious non-infectious causes of fever (e.g. drug and transfusion related),
Other illness
- known etiology of fever, defined by a clinically significant positive culture (blood, urine, tracheal) collected during the feverish episode or a clinically documented focal infection despite negative cultures (e.g. pneumonia and cellulitis),
Other
- children requiring prophylactic antibacterial antibiotics according to protocol besides co-trimoxazole for Pneumocystis jirovecii after the febrile episode.
Who the study is looking for
- patient with cancer aged 18 years or below,
- absolute neutrophil count below 0.5x10⁹/L with expected duration of neutropenia for more than 7 days, and
- a single temperature of at least 38.5°C, or a temperature above 38.0°C sustained over a 1-hour period (auricular, oral or rectal).
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Skejby Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Odense Univesity Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
Related publications
- Early discontinuation of empirical antibiotics versus extended treatment in children with cancer and high-risk febrile neutropenia in Denmark: an open-label, randomised controlled trial.Lancet Child Adolesc Health · 2026 · PMID 41990768
This page is information, not medical advice. Discuss any trial with your doctor.