Clinical Trials

 

Early Termination of Empirical Antibiotics in High-risk Febrile Neutropenia in Children With Cancer: an Open-label, Randomised, Controlled Trial

Intervention Type: Other
Study Type: Interventional
Sponsors: Kjeld Schmiegelow
Participants: 220
Abstract
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.
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    Facilities
    Aarhus University Hospital Skejby - Not yet recruiting
    Aarhus, Denmark
    Odense Univesity Hospital - Not yet recruiting
    Odense, Denmark
    Rigshospitalet - Recruiting
    Copenhagen, Denmark
    Contacts
    Primary
    Nadja Vissing, MD, PhD
    nadja.hawwa.vissing@regionh.dk
    +4535451312
    Backup
    Ulrikka Nygaard, MD, PhD
    ulrikka.nygaard@regionh.dk
    +4535459761
    Eligibilities
    Sex: All
    Maximum Age: 18
    Healthy Volunteers: No
    Inclusion Criteria (for each episode):
    - 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).
    Exclusion Criteria (for each episode):
    - 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),
    - obvious non-infectious causes of fever (e.g. drug and transfusion related),
    - children requiring prophylactic antibacterial antibiotics according to protocol besides co-trimoxazole for Pneumocystis jirovecii after the febrile episode.

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