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, randomized controlled trial in Pakistan

Tabish Hazir ^1*, Shamim A Qazi ², Yasir Bin Nisar ³, Sajid Maqbool ⁴, Rai Asghar ⁵, Imran Iqbal ⁶, Sobia Khalid ¹, Sajid Randhawa ⁴, Shazia Aslam ⁵, Sobia Riaz ⁶ and Saleem Abbasi ³

¹ Children Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan
² Child and Adolescent Health and Development, WHO, Geneva, Switzerland
³ ARI Research Cell, Children Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan
⁴ Children Hospital, Lahore, Pakistan
⁵ Rawalpindi General Hospital, Rawalpindi, Pakistan
⁶ Nishtar Hospital, Multan, Pakistan

^* To whom correspondence should be addressed. E-mail: arichi99{at}ariresearch.edu.pk.

Accepted 7 March 2006

Abstract

Introduction: 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 MIC's of S. Pneumoniae and H. Influenzae for amoxicillin. Microbiological data shows that this resistance can be overcome by increasing amoxicillin dosage. Based on this data we studied the question whether we can improve the clinical outcome in non-severe pneumonia by doubling the dose of amoxicillin.

Methodology: Double blind randomized controlled trial was conducted in the outpatient departments of four large hospitals in Pakistan. Children 2-59 months with non-severe pneumonia were randomized to receive either standard (45 mg/kg/day) or double dose (90 mg/kg/day) oral amoxicillin for 3 days and 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 randomized to standard and 439 to double dose of oral amoxicillin. Twenty (4.5%) children in standard and 25 (5.7%) in double dose group had therapy failure by day 5. Including the relapses, cumulative therapy failure by day 14 was 26 (5.9%) with standard and 35 (7.9%) with double dose amoxicillin. These differences were not statistically significant (p-values = 0.55 and 0.29).

Conclusion: Clinical outcome in children 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 three-day course in standard dose.

Keywords: WHO ARI guidelines, child, non-severe pneumonia, oral amoxicillin

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