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Sponsors and Collaborators: |
Pakistan Institute of Medical Sciences World Health Organization |
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Information provided by: | Pakistan Institute of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00851487 |
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 |
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Acute Respiratory Infections Pneumonia |
Drug: Amoxicillin Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Multicentre Double Blind Trial of Amoxicillin Compared With Placebo for Treatment of WHO Defined Non-Severe Pneumonia in Children Aged 2-59 Months: NARIMA Study Group |
Enrollment: | 900 |
Study Start Date: | January 2006 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Amoxicillin: Experimental
Oral amoxicillin in the dose of 15 mg/kg/dose 8 hourly was given as an active drug
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Drug: Amoxicillin
Oral Amoxicillin 15 mg/kg/dose 8 hourly
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Placebo: Placebo Comparator
The placebo was similar in colour, consistency and volume as oral amoxicillin
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Drug: Placebo
The placebo was similar in colour, consistency and volume as oral amoxicillin
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Ages Eligible for Study: | 2 Months to 59 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
WHO signs of severe pneumonia recognised by lower chest wall retraction. Children who present with wheezing will be evaluated for lower chest wall indrawing after treatments with nebulised salbutamol. WHO signs of very severe disease/pneumonia defined as any of the following:
Pakistan, Federal Capital | |
ARI Research Cell, Children Hospital, PIMS | |
Islamabad, Federal Capital, Pakistan, 44000 |
Principal Investigator: | Dr. Tabish Hazir, FCPS-Peds | Overall Head of Research Cell |
Study Director: | Dr. Yusra Ashraf, MBBS | Research Administrator to ARI Research Cell |
Responsible Party: | ARI Research Cell, Children Hospital, PIMS, Islamabad ( Dr. Tabish Hazir ) |
Study ID Numbers: | NARIMA Study Group |
Study First Received: | February 25, 2009 |
Last Updated: | February 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00851487 History of Changes |
Health Authority: | Pakistan: Ministry of Health |
ARI LRTI |
Anti-Infective Agents Anti-Bacterial Agents Amoxicillin Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases Pneumonia |
Anti-Infective Agents Anti-Bacterial Agents Amoxicillin Respiratory Tract Diseases Respiratory Tract Infections |
Therapeutic Uses Lung Diseases Infection Pharmacologic Actions Pneumonia |