Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

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).
    

Detailed description: 
      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.
    

Intervention name(s): ceftriaxone
Intervention type(s): Drug
Intervention MeSH terms: Ceftriaxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ceftriaxone; chloramphenicol; severe pneumonia; children