The purpose of this study is to determine whether oral zinc supplements plus standard antibiotics significantly alter the duration of the required hospitalization in children who are hospitalized with radiologicallly confirmed acute pneumonia.

Condition	Intervention	Phase
Pneumonia	Drug: Zinc (mineral)	Phase III

Further Study Details: 

Primary Outcomes: To determine whether oral zinc supplements plus standard antibiotics significantly alters the duration of hospitalization of children with radiologicallly confirmed acute pneumonia.
Expected Total Enrollment:  600

This is a two-arm, randomized, double-blinded, placebo-controlled trial of zinc as adjuvant therapy. Approximately 600 children aged six months to 36 months, who are admitted with a primary clinical diagnosis of acute pneumonia, which will be radiologically confirmed will be randomized to receive or placebo from the time of enrollment into the study on admission to hospital to the time of hospital discharge. All participants will receive antibiotics for a duration of 14 days as per standard of care.

Ages Eligible for Study:  6 Months   -   36 Months,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Radiologicallly confirmed pneumonia

Exclusion Criteria:

-

Please refer to this study by ClinicalTrials.gov identifier  NCT00197717

Maulid Fataki, MD, MMed, MPH       mfataki@muchs.ac.tz
Wafaie W Fawzi, MD, DrPH      617-432-2086    mina@hsph.harvard.edu

Massachusetts
      Harvard School of Public Health, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Maulidi Fataki, MD, MMed, MPH,  Principal Investigator,  Muhimbili University College of Health Sciences   

Study ID Numbers:  DMID 03-179
Last Updated:  September 19, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00197717
Health Authority: United States: Federal Government; Tanzania: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-20