Skip to main content
. 2013 Jun 4;2013(6):CD004874. doi: 10.1002/14651858.CD004874.pub4

Awasthi 2008.

Methods Cluster‐randomised, open‐label trial
Participants Children of either sex, between 2 months to 59 months with WHO‐defined non‐severe pneumonia
Interventions Eligible children were randomised to receive oral dispersible scored amoxycillin (125 mg per tablet) given thrice a day (tds) for 3 days or co‐trimoxazole (20 mg trimethoprim per tablet) given twice a day (bd) for 5 days. Doses of amoxycillin were between 31 to 51 mg/kg/day and trimethoprim 7 to 11 mg/kg/day
Outcomes Primary outcome measure was clinical failure defined as presence of at least 1 of the following: (i) development of signs of WHO‐defined severe pneumonia or very severe disease (ii) respiratory rate above age specific cut‐off, (iii) documented axillary temperature > 38.3 °C on the day of outcome assessment, that is day 4 for amoxycillin and day 6 for co‐trimoxazole arm, (iv) death within the follow‐up period of 14 days, (v) lost to follow‐up on day 4 or day 6 in the amoxycillin and co‐trimoxazole arms, respectively, or (vi) withdrawal at any time (requirement of intention‐to‐treat (ITT) analysis)
The secondary outcome measure was clinical relapse on day 13 to 15, defined as development of signs of WHO‐defined pneumonia among the clinically cured in either arm
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomly allocated
Allocation concealment (selection bias) Low risk This was an open‐label study and the unit of randomisation was primary health centre
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Open‐label randomised controlled trial
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open‐label randomised controlled trial
Selective reporting (reporting bias) Low risk No selective reporting
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Incomplete data adequately addressed
Other bias Low risk Funded by Indian Council of Medical Research