Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute lower respiratory tract infections are a leading cause of morbidity and mortality in sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous chloramphenicol for the treatment of severe pneumonia in children aged less than five years. However, up to 20% of children fail treatment due to the emergence of resistance by bacteria. Several centers now use ceftriaxone, a third generation cephalosporin, which is reported to be efficacious in the treatment of severe pneumonia. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. The purpose of this study is to compare chloramphenicol and ceftriaxone in the treatment of severe pneumonia in children under five.

We hypothesize that 92.7% of children who receive once daily intravenous ceftriaxone (75 mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80.2 % of those who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Treatments: Ceftriaxone; Chloramphenicol; Chloramphenicol succinate

Criteria

Inclusion Criteria:

• Children aged 6 months to 59months with cough, difficult breathing and lower chest indrawing

• Consent from parent/carer

Exclusion Criteria:

• Children with severe Asthmatic attack

• Allergy to any of the study drugs

• Diagnosis of Pneumocystis JiroveciPneumonia on therapeutic treatment