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
- Tabish Hazir1,
- Shamim A Qazi2,
- Yasir Bin Nisar1,
- Sajid Maqbool3,
- Rai Asghar4,
- Imran Iqbal5,
- Sobia Khalid1,
- Sajid Randhawa3,
- Shazia Aslam4,
- Sobia Riaz5,
- Saleem Abbasi1
- 1Children’s Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan
- 2Child and Adolescent Health and Development, WHO, Geneva, Switzerland
- 3Children’s Hospital, Lahore, Pakistan
- 4Rawalpindi General Hospital, Rawalpindi, Pakistan
- 5Nishtar Hospital, Multan, Pakistan
- Correspondence to:
Dr Tabish Hazir
ARI Research Cell, Children’s Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan; arichi99{at}ariresearch.edu.pk
- Accepted 7 March 2006
- Published Online First 17 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 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).
Conclusion: 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.
Footnotes
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Published Online First 17 March 2006
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Competing interests: None.
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Protocol development and study monitoring: Dr Tabish Hazir, Dr Shamim A Qazi, Dr Yasir Bin Nisar.
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Study implementation: Dr Yasir Bin Nisar, Dr Sobia Khalid (Children’s Hospital, Islamabad), Professor Sajid Maqbool, Dr Sajid Randhawa (Children’s Hospital, Lahore), Dr Rai Asghar, Dr Shazia Aslam (Rawalpindi General Hospital, Rawalpindi), Dr Imran Iqbal, Dr Sobia Riaz (Nishtar Hospital, Multan).
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Data analysis and report preparation: Dr Tabish Hazir, Dr Yasir Bin Nisar, Dr Sobia Khalid, Mr Saleem Abbasi (Children’s Hospital, Islamabad), Dr Shamim A Qazi (Department of Child and Adolescent Health and Development, WHO, Geneva), Professor Sajid Maqbool, Dr Sajid Randhawa (Children’s Hospital, Lahore), Dr Rai Asghar, Dr Shazia Aslam (Rawalpindi General Hospital, Rawalpindi), Dr Imran Iqbal, Dr Sobia Riaz (Nishtar Hospital, Multan).
