Study of the usefulness of treatment of fungal infections in children with cancer and compromise of their immunity

Phase 2

• Conditions: Febrile neutropenia; C15.378.553.546.184.564.750

• Registration Number: RBR-3m9d74
• Lead Sponsor: Fondo Nacional de Desarrollo Cientifico y Tecnologico, Chile

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Children and adolescent with cancer; less or equal to 18 years of age; admitted because of a febrile neutropenia episode.
Informed consent of the parent or legal guardian
assent if older than 8 years of age.

Exclusion Criteria

Children with hematopoietic stem cell transplant.
Children with cancer under voriconazole or posaconazole prophylaxis.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall mortality at day 30 of follow-up.<br><br>Expected primary outcome: overall mortality at day 30 of follow up of 6%.;Observed primary outcome: overall mortality at day 30 of follow up was 6,7% (10/149).

Secondary Outcome Measures

Name	Time	Method
Invasive fungal disease related mortality (number, percentage).<br><br><br><br>;Number of days of fever, number of days of hospitalization and number of days of antifungal use.;Percentage (%) of episodes that developed an Invasive fungal disease.;Percentage (%) of episodes requiring modification of initial treatment strategy.;Percentage of episodes requiring admission to the Intensive Care Unit.