Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi.

ABSTRACT:

Introduction

Pneumonia is the leading infectious killer of children. We conducted a double-blind, randomised controlled non-inferiority trial comparing placebo to amoxicillin treatment for fast breathing pneumonia in HIV-negative children aged 2-59 months in Malawi. Occurrence of serious adverse events (SAEs) during the trial were examined to assess disease progression, co-morbidities, recurrence of pneumonia and side effects of amoxicillin.

Methods

Enrolled children with fast breathing for age and a history of cough <14 days or difficult breathing were randomised to either placebo or amoxicillin for 3 days, and followed for 14 days to track clinical characteristics and outcomes. Medical history, physical exam, laboratory results and any chest radiographs collected at screen

SUBMITTER: Nkwopara E 

PROVIDER: S-EPMC6733335 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature