Safety and Efficacy of Ambulatory Versus In-hospital Antibiotic Treatment in Children With Febrile Neutropenia

NACompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

July 1, 2015

Primary Completion Date

September 30, 2017

Study Completion Date

October 8, 2017

Conditions
Chemotherapy-Induced Febrile Neutropenia
Interventions
OTHER

Outpatient oral treatment.

Participants allocated in oral outpatient group were discharged home with oral antibiotic to continue management. Participants were given Cefixime oral suspension (100 mg/5 mL). Antibiotic was given to the caretakers with written instructions about dosage and time of administration. Dosage indicated was 8 mg/kg/day to be given orally as a single dose (max dose 400 mg/day). Oral antibiotic treatment was given until documented ANC \> 500, failure to treatment (restart of fever) or when 14 days of antibiotic were completed (whichever occurred first).

OTHER

Inpatient intravenous treatment.

Participants allocated in the intravenous inpatient group continued receiving Cefepime 150 mg/kg/day every 8 hours (max dose 2 grams per dose or 6 grams per day) according to local standard of care guidelines. Intravenous antibiotic treatment was given until documented ANC \> 500, failure to treatment (restart of fever) or when 14 days of antibiotic were completed (whichever occurred first).

All Listed Sponsors
collaborator

Instituto Nacional de Pediatria

UNKNOWN

collaborator

Hospital Juarez de Mexico

OTHER_GOV

lead

Hospital Infantil de Mexico Federico Gomez

OTHER

NCT04000711 - Safety and Efficacy of Ambulatory Versus In-hospital Antibiotic Treatment in Children With Febrile Neutropenia | Biotech Hunter | Biotech Hunter