Zinc Pneumonia Outpatient Trial in Children < 2 Years
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|ClinicalTrials.gov Identifier: NCT00142285|
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Drug: Zinc sulphate (20 mg)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2260 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Zinc in the Treatment of Outpatient Pneumonia in an Urban Slum Among Children Less Than 2 Years Old|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2008|
- Duration of illness
- Treatment failure
- Incidence of subsequent illness episodes (pneumonia and any other)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142285
|Kamalapur Urban Site, ICDDR,B: Centre for Health & Population Research|
|Principal Investigator:||W. Abdullah Brooks, MD, MPH||ICDDR,B: Centre for Health & Population Research|