Comparison of standard versus double dose of amoxicillin in the treatment of non-severe pneumonia in children aged 2-59 months: a multi-centre, double blind, randomised controlled trial in Pakistan.
BACKGROUND
WHO pneumonia case management guidelines recommend oral amoxicillin as first line treatment for non-severe pneumonia. Increasing treatment failure rates have been reported over a period of time, which could possibly be due to increasing minimum inhibitory concentrations of Streptococcus pneumoniae and Haemophilus influenzae for amoxicillin. Microbiological data show that this resistance can be overcome by increasing amoxicillin dosage. Based on this data, we examined whether we can improve the clinical outcome in non-severe pneumonia by doubling the dose of amoxicillin.


METHODS
A double blind randomised controlled trial was conducted in the outpatient departments of four large hospitals in Pakistan. Children aged 2-59 months with non-severe pneumonia were randomised to receive either standard (45 mg/kg/day) or double dose (90 mg/kg/day) oral amoxicillin for 3 days and then followed up for 14 days. Final outcome was treatment failure by day 5.


RESULTS
From September 2003 to June 2004, 876 children completed the study. 437 were randomised to standard and 439 to double dose oral amoxicillin. 20 (4.5%) children in the standard and 25 (5.7%) in the double dose group had therapy failure by day 5. Including the relapses, by day 14 there were 26 (5.9%) cumulative therapy failures with standard and 35 (7.9%) with double dose amoxicillin. These differences were not statistically significant (p = 0.55 and p = 0.29, respectively).


CONCLUSIONS
Clinical outcome in children aged 2-59 months with non-severe pneumonia is the same with standard and double dose oral amoxicillin. Non-severe pneumonia can be treated effectively and safely with a 3 day course of a standard dose.
Children's Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan. arichi99@ariresearch.edu.pk
Tabish
T
Hazir
Shamim A
SA
Qazi
Yasir
Y
Bin Nisar
Sajid
S
Maqbool
Rai
R
Asghar
Imran
I
Iqbal
Sobia
S
Khalid
Sajid
S
Randhawa
Shazia
S
Aslam
Sobia
S
Riaz
Saleem
S
Abbasi
D017677:Age Distribution; D000658:Amoxicillin / Q000008:administration & dosage* / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002675:Child, Preschool; D003906:Developing Countries; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D017211:Treatment Failure; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000658:Amoxicillin