Safety and Efficacy of Ambulatory Versus In-hospital Antibiotic Treatment in Children With Febrile Neutropenia
Chemotherapy-Induced Febrile Neutropenia
About this trial
This is an interventional treatment trial for Chemotherapy-Induced Febrile Neutropenia focused on measuring Fever and neutropenia, Febrile neutropenia, Cancer, Outpatient treatment, Children
Eligibility Criteria
Inclusion Criteria:
- Children from 1 to 18 years of age.
- Underlying cancer diagnosis that presented with fever and neutropenia secondary to chemotherapy and after 48-72 hours of inpatient intravenous treatment with Cefepime, were hemodynamically stable, remained afebrile for at least 24 hours, and did not have a documented source of infection.
- Participants whose caretaker knew how to read and write and accepted to be part of the clinical trial.
Exclusion Criteria:
- Participants with positive cultures.
- Absolute neutrophil count (ANC) < 100/mm3.
- Thrombocytopenia < 30,000/mm3.
- Less than 7 days have passed from the start of the last chemotherapy session.
- Leukemia on remission induction therapy.
- Relapsed leukemia.
- Mucositis grade III or IV.
- Participants with allergy to cefixime.
- Need to receive any other medication intravenously.
- Need of oxygen support, parenteral nutrition or intravenous fluids.
- Oral intolerance.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Outpatient oral antibiotic treatment group.
Inpatient intravenous antibiotic treatment group.
After randomization, participants assigned to receive outpatient treatment with oral cefixime at a dose of 8 mg/kg/day were discharged. Treatment was provided by the researchers. Subjects were evaluated daily at the outpatient clinic of the hospital. All patients underwent a blood count every 48 to 72 hours. FN event resolution was defined as when the patient remained afebrile and the ANC increased to above 500 per microliter. If fever resumed in the outpatient group, they were re-admitted to the hospital to receive intravenous antibiotics. Resolution of the FN event was defined as the end of participation of the subjects in the study, and they were followed up for an additional 72 hours.
After randomization, participants continued intravenous inpatient antibiotic with cefepime 150 mg/kg/day according to local standard of care guidelines. Subjects were evaluated daily. All patients underwent a blood count every 48 to 72 hours. FN event resolution was defined as when the patient remained afebrile and the ANC increased to above 500 per microliter. If fever resumed, treatment was changed according to clinical guidelines. Resolution of the FN event was defined as the end of participation of the subjects in the study, and they were followed up for an additional 72 hours.