Chloramphenicol versus benzylpenicillin and gentamicin for the treatment of severe pneumonia in children in Papua New Guinea: a randomised trial.
BACKGROUND
Pneumonia is the most frequent cause of child mortality in less-developed countries. We aimed to establish whether the combination of benzylpenicillin and gentamicin or chloramphenicol would be better as first-line treatment in children with severe pneumonia in Papua New Guinea.


METHODS
We did an open randomised trial in which we enrolled children aged 1 month to 5 years of age who fulfilled the WHO criteria for very severe pneumonia and who presented to hospitals in two provinces. Children were randomly assigned to receive chloramphenicol (25 mg/kg 6 hourly) or benzylpenicillin (50 mg/kg 6 hourly) plus gentamicin (7.5 mg/kg daily) by intramuscular injection. The primary outcome measure was a good or an adverse outcome.


RESULTS
1116 children were enrolled; 559 children were treated with chloramphenicol and 557 with benzylpenicillin and gentamicin. At presentation the median haemoglobin oxygen saturation was 71% (IQR 57-77) for those allocated chloramphenicol and 69% (55-77) for those allocated penicillin and gentamicin. 147 (26%) children treated with chloramphenicol and 123 (22%) treated with penicillin and gentamicin had adverse outcomes (p=0.11). 36 children treated with chloramphenicol and 29 treated with penicillin and gentamicin died. More children treated with chloramphenicol than penicillin and gentamicin represented with severe pneumonia within 1 month of hospital discharge (p=0.03).


CONCLUSIONS
For children with severe pneumonia in less-developed countries the probability of a good outcome is similar if treated with chloramphenicol or with the combination of benzylpenicillin and gentamicin.
Duke
Trevor
T
Department of Paediatrics, Goroka Base Hospital, PO Box 392, Goroka, Papua New Guinea. duket@cryptic.rch.unimelb.edu.au
Poka
Harry
H
Dale
Frank
F
Michael
Audrey
A
Mgone
Joyce
J
Wal
Tilda
T
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002675:Child, Preschool; D002701:Chloramphenicol / Q000627:therapeutic use*; D015897:Comorbidity; D004359:Drug Therapy, Combination; D005260:Female; D005839:Gentamicins / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D008297:Male; D009512:New Guinea; D010400:Penicillin G / Q000627:therapeutic use*; D011014:Pneumonia / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D005839:Gentamicins; D002701:Chloramphenicol; D010400:Penicillin G