NCT00142285

Zinc Pneumonia Outpatient Trial in Children < 2 Years

Efficacy of Zinc in the Treatment of Outpatient Pneumonia in an Urban Slum Among Children Less Than 2 Years Old

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,260 (estimated)
• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh · Academic / Other
• Sex: All
• Age: 1 Week – 23 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether zinc can be used in combination with standard antibiotics to reduce the duration of illness and the likelihood of treatment failure among children less than two years old who have non-severe, outpatient pneumonia.

Detailed description

This study is a follow up to an earlier study among hospitalised children less than two years old with severe pneumonia who were administered zinc as an adjuvant along with standard antimicrobial agents. That study found a 20% reduction in illness duration and hospitalisation, as well as a 3 - 9 fold reduction in treatment failure for children given zinc along with standard antimicrobial management. However, since most pneumonia is managed in an outpatient setting, it is important to know if it works in this setting as well. We hypothesise that zinc may act as an acute phase reactant in the early stages of outpatient non-severe pneumonia to reduce both the duration of illness and the likelihood of treatment failure. To test this, we will randomise children less than two years old to receive either zinc or placebo can as an adjuvant to standard oral antimicrobial agents in the acute treatment of non-severe pneumonia in an outpatient urban setting. Oral antibiotics will be given for a standard five-day course, while zinc (20 mg) or placebo will be administered once-daily for 10 days. Patients will be followed up on a daily basis at home to monitor their progress and document compliance. Outcomes will be a comparison between zinc and placebo groups on duration of illness, as measured by specific signs of pneumonia, and treatment failure, as measured by change of antibiotics or hospitalisation for failure to improve or worsening condition.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	Zinc sulphate (20 mg)

Timeline

• Start date: 2004-11-01
• Primary completion: 2006-05-01
• Completion: 2008-05-01
• First posted: 2005-09-02
• Last updated: 2022-02-11

Locations

1 site across 1 country: Bangladesh