Status:
COMPLETED
ICMR-Indiaclen Trial on Amoxycillin vs Cotrimoxazole for Non-Severe Pneumonia
Lead Sponsor:
King George's Medical University
Collaborating Sponsors:
Indian Council of Medical Research
United States Agency for International Development (USAID)
Conditions:
Non-Severe Pneumonia
Under-Fives
Eligibility:
All Genders
2-59 years
Phase:
PHASE3
Brief Summary
Background: With documented rise in bacterial resistance in vitro to co-trimoxazole, there is a need to document in vivo effectiveness of the drug in treatment of non-severe pneumonia in the community...
Eligibility Criteria
Inclusion
- Children aged 2-59 months with non-severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off with or without wheeze, accessible to follow up, whose guardians give written informed consent.
Exclusion
- Children with severe disease, other infectious disease requiring antibiotic treatment, documented use of antibiotic for the last 48 hours, three or more episodes of wheezing in a year, diagnosed asthmatics, known immunodeficiency disease, acute or chronic organic disease, history of hospitalization within last 15 days, measles within last one month, drug allergy, refusal to give consent, prior enrollment in the study.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00396526
Start Date
April 1 2004
End Date
April 1 2006
Last Update
December 7 2006
Active Locations (1)
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1
Dr. Shally Awasthi
Lucknow, Uttar Pradesh, India, 226003