Zinc Pneumonia Outpatient Trial in Children < 2 Years - Article Orazinc; Verazinc; Zinc 15; Zinc Gluconate; Zinc Sulfate; Zincate
Clinical Trial: Zinc Pneumonia Outpatient Trial in Children < 2 Years
This study is currently recruiting patients.
Verified by International Centre for Diarrhoeal Disease Research, Bangladesh September 2005
|Pneumonia || Drug: Zinc sulphate (20 mg) ||Phase III |
MedlinePlus related topics: Pneumonia
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Secondary Outcomes: Incidence of subsequent illness episodes (pneumonia and any other)
Expected Total Enrollment: 2260
Study start: November 2004; Expected completion: June 2007
Last follow-up: October 2006; Data entry closure: January 2007
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.
- Clinical diagnosis of pneumonia
- 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
Location and Contact Information
Dilruba Nasrin, MBBS, PhD 88 02 9881662 email@example.com
Kamalapur Urban Site, ICDDR,B: Centre for Health & Population Research, Dhaka, Bangladesh; Recruiting
W. Abdullah Brooks, MD, MPH, Principal Investigator
Dilruba Nasrin, MBBS, PhD, Sub-Investigator
W. Abdullah Brooks, MD, MPH, Principal Investigator, ICDDR,B: Centre for Health & Population Research
Last Updated: September 1, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00142285
Health Authority: Bangladesh: Directorate of Drug Administration; Bangladesh: Ethical Review Committee
ClinicalTrials.gov processed this record on 2005-09-06