Pneumonia Clinical Trial
Official title:
Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children Aged Less Than Five Years at Mulago Hospital: A Randomized Controlled Trial
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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