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Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59
Months
This study has been completed.
First Received: February 25, 2009 No Changes Posted
Pakistan Institute of
Sponsor:
Medical Sciences
World Health
Collaborator:
Organization
ClinicalTrials.g
NCT00851487
ov Identifier:
Purpose
Many children with "non-severe pneumonia" (cough and fast breathing) have neither
clinical pneumonia as assessed by physicians nor pneumonia on chest radiographs.
Inappropriate use of antibiotics for these cases is leading to resistant strains of
bacteria in the community. Evidence shows that almost 50% of antibiotic prescription
is unnecessary.As over half of antibiotic prescription for ARI are not necessary since
most of these infections are viral and do not respond to antibiotic therapy which will
be source of resistance in the community.
To address this issue the investigators conducted this randomized, double blind
placebo controlled clinical trial of oral Amoxicillin versus placebo in children with
non-severe pneumonia taking into account all the necessary safety precautions for
their well being.
The study hypothesis was that the clinical outcome of children 2 to 59 months of age
with cough and fast breathing (WHO defined non-severe pneumonia) with or without
wheezing is equivalent, whether they are treated with amoxicillin or placebo.
Condition Intervention
Acute Respiratory Infections Drug: Amoxicillin
Pneumonia Drug: Placebo
Enrollment: 900
Primary Completion Date: April 2008 (Final data collection date for primary
outcome measure)
Eligibility
Locations
Pakistan
ARI Research Cell, Children Hospital, PIMS
Islamabad, Federal Capital, Pakistan, 44000
Sponsors and Collaborators
Pakistan Institute of Medical Sciences
World Health Organization
Investigators
Principal Dr. Tabish Hazir,
Overall Head of Research Cell
Investigator: FCPS-Peds
Dr. Yusra Ashraf, Research Administrator to ARI
Study Director:
MBBS Research Cell
More Information
Additional Information:
The URL has the background, contacts, personnel, publications, project status of ARI
Research Cell
No publications provided