NCT02678195

3 Days Versus 5 Days Amoxicillin for Chest-indrawing Childhood Pneumonia in Malawi

Double-blind Randomized Controlled Clinical Trial of 3 Days Versus 5 Days Amoxicillin Dispersible Tablets for Chest-indrawing Childhood Pneumonia Among Children 2-59 Months of Age Presenting to Kamuzu Central Hospital in Lilongwe, Malawi

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,000 (actual)
• Sponsor: Save the Children · Academic / Other
• Sex: All
• Age: 2 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	Amoxicillin	Oral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
DRUG	Placebo	Placebo dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-04-01
• Completion: 2019-12-01
• First posted: 2016-02-09
• Last updated: 2021-02-18

Locations

2 sites across 1 country: Malawi