Treatment of World Health Organization (WHO) defined non-severe pneumonia in developing countries with three days or five days of oral cotrimoxazole

Phase 4

Completed

• Conditions: on-severe Pneumonia; Non-severe Pneumonia; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12612000994886
• Lead Sponsor: The University of Colorado at Denver and The Children’s Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

The inclusion criteria were: children aged 2-59 months with WHO defined non-severe pneumonia

Exclusion Criteria

- children with WHO defined severe or very severe pneumonia or any other severe disease
- children with a history of an allergic reaction to cotrimoxazole or three or more episodes of wheeze or current diagnosis of acute asthma
- those who had been enrolled earlier in the study; required antibiotics for any other condition; had been hospitalized in the previous 2 weeks or who had severe malnutrition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcomes on fast breathing. The infants and children were followed up 5 days after enrollment when caretakers were asked about the clinical condition and subjects were assessed clinically for fast breathing. To evaluate fast breathing, the mean of two respiratory rates counted for 1 minute each within 5 minutes was used for all children, when the child was quiet, feeding, or asleep. Children who failed therapy were referred to the hospital for management. Study staff followed children at home if they did not come for follow-up.[Five days]

Secondary Outcome Measures

Name	Time	Method
Relapse. On Day 15, we conducted a full clinical assessment, assessed for relapse. A relapse was defined as the appearance of any signs of pneumonia after at least 3 days of being free of symptoms from the original episode.[Fifteen days]