Zinc Pneumonia Outpatient Trial in Children < 2 Years

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142285
• Other study ID #: 2004-010
• Status: Completed
• Phase: Phase 3
• Start date: November 2004
• Est. completion date: May 2008

Study information

• Verified date: July 2006
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2260
• Est. completion date: May 2008
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 23 Months

Eligibility

Inclusion Criteria:

• Clinical diagnosis of pneumonia

Exclusion Criteria:

• Wheezing at presentation History of chronic lung, heart or other system disease suspected tuberculosis, active measles, severe malnutrition requiring hospitalisation, signs of systemic illness (sepsis, meningitis), those who have already received zinc/placebo supplements during this study, those known to be pre-treated with antibiotics prior to presenting to clinic

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Zinc sulphate (20 mg)

Locations

Country	Name	City	State
Bangladesh	Kamalapur Urban Site, ICDDR,B: Centre for Health & Population Research	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Bill and Melinda Gates Foundation, Thrasher Research Fund

Country where clinical trial is conducted

Bangladesh, 

References & Publications (1)

Brooks WA, Yunus M, Santosham M, Wahed MA, Nahar K, Yeasmin S, Black RE. Zinc for severe pneumonia in very young children: double-blind placebo-controlled trial. Lancet. 2004 May 22;363(9422):1683-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of illness
Primary	Treatment failure
Secondary	Incidence of subsequent illness episodes (pneumonia and any other)

External Links

•   Link to articles about JHU publications
•   Link to ICDDR,B, then click on 'Publications' or 'Programmes and themes'