Status:
COMPLETED
Randomized Controlled Trial (RCT) in Children With Severe Pneumonia
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Severe Pneumonia
Eligibility:
All Genders
2-59 years
Phase:
NA
Brief Summary
Pneumonia is the leading cause of childhood morbidity and death in many developing countries including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an infection of the ...
Detailed Description
Acute lower respiratory infection (ALRI), particularly pneumonia is the leading cause of childhood morbidity and death in the developing countries including Bangladesh. Acute respiratory infection (AR...
Eligibility Criteria
Inclusion
- Age: 2 to 59 months
- Sex: Both boys and girls
- Severe pneumonia according to WHO criteria (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate ≥ 50 breaths per minute for children aged 2-11 months and ≥ 40 breaths per minute for children aged 12-59 months)
- Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday)
- Written informed consent by respective parents/guardians
Exclusion
- Very severe and non-severe pneumonia
- Nosocomial pneumonia
- History of taking antibiotics for pneumonia within 48 hour prior to enrollment
- Chronic illnesses like tuberculosis, cystic fibrosis
- Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease
- Immunodeficiency
- Trauma/burn
- Bronchiolitis
- Bronchial asthma
- Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site)
- Parents/guardians not consenting for inclusion of their children in the study
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT00455468
Start Date
December 1 2005
End Date
April 1 2009
Last Update
July 12 2011
Active Locations (1)
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1
ICDDR,B
Dhaka, Bangladesh, 1212