Zinc Pneumonia Outpatient Trial in Children < 2 Years
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia |
Drug: Zinc sulphate (20 mg) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Efficacy of Zinc in the Treatment of Outpatient Pneumonia in an Urban Slum Among Children Less Than 2 Years Old |
- Duration of illness
- Treatment failure
- Incidence of subsequent illness episodes (pneumonia and any other)
| Estimated Enrollment: | 2260 |
| Study Start Date: | November 2004 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Bangladesh | |
| Kamalapur Urban Site, ICDDR,B: Centre for Health & Population Research | |
| Dhaka, Bangladesh | |
| Principal Investigator: | W. Abdullah Brooks, MD, MPH | ICDDR,B: Centre for Health & Population Research |
More Information
Additional Information:
Publications:
| Responsible Party: | Principal Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT00142285 History of Changes |
| Other Study ID Numbers: | ICDDR,B 2004-010 |
| Study First Received: | September 1, 2005 |
| Last Updated: | January 6, 2013 |
| Health Authority: | Bangladesh: Directorate of Drug Administration Bangladesh: Ethical Review Committee |
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
|
pneumonia zinc treatment efficacy children |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Zinc Zinc Sulfate Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Astringents Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013