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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00142285
Enrollment
2260
Registered
2005-09-02
Start date
2004-11-30
Completion date
2008-05-31
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

pneumonia, zinc, treatment, efficacy, children

Brief 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.

Interventions

DRUGZinc sulphate (20 mg)

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 23 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Duration of illness
Treatment failure

Secondary

MeasureTime frame
Incidence of subsequent illness episodes (pneumonia and any other)

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026