Zinc Pneumonia Outpatient Trial in Children < 2 Years

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: Zinc sulphate (20 mg)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zinc sulphate (20 mg)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of illness |  |  | 
| Treatment failure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of subsequent illness episodes (pneumonia and any other) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, zinc, treatment, efficacy, children