A Phase 3 interventional study of ceftriaxone in Pneumonia, sponsored by Makerere University. Completed at 4 sites in Uganda. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2010-07-26.
Sponsored by Makerere University · Phase 3, Interventional, and Treatment
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).
A recent report from the World health Organization showed pneumonia was the leading cause of death in children less than 5 years. WHO recommends intravenous Chloramphenicol 25mg/kg six hourly as the first line drug for the treatment of severe pneumonia in these children. Ceftriaxone 75mg/kg daily is the second line drug.
The efficacy of chloramphenicol for the treatment of severe pneumonia ranges from 80%-84%, while that of ceftriaxone ranges from 85% to 97%. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. A study comparing penicillin G plus chloramphenicol and ceftriaxone in the treatment of severe pneumonia in Turkey found that both drugs were equally effective in normalization of the outcome parameters. A recent Cochrane review found no randomized controlled trials comparing both drugs in the treatment of severe forms of pneumonia.
The objective of this study it to compare the efficacy of Ceftriaxone versus Chloramphenicol in the treatment of severe pneumonia in the children under five years of age admitted to Mulago hospital.
This will be a double- blinded randomized controlled trial. Three hundred forty eight children with severe pneumonia will be randomized to receive either intravenous ceftriaxone 75mg/kg/day for seven days or intravenous chloramphenicol 100mg/kg/day for seven days. The primary outcome will mortality and secondary outcomes will be time taken to normalization of respiratory rate, temperature and oxygen saturation.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 348 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Makerere University is the lead sponsor of 143 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mortality from severe pneumonia by 7th day of treatment
Time to normalisation of respiratory rate
Time to normalisation temperature
Time to normalisation of oxygen saturation
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Makerere University