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 |
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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 |