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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.

AbstractINTRODUCTION: 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.
AuthorsTabish Hazir, Shamim A Qazi, Yasir Bin Nisar, Sajid Maqbool, Rai Asghar, Imran Iqbal, Sobia Khalid, Sajid Randhawa, Shazia Aslam, Sobia Riaz, Saleem Abbasi (Affiliation: Children's Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan. arichi99 at ariresearch.edu.pk)
JournalArchives of disease in childhood (Arch Dis Child) Vol. 92 Issue 4 Pg. 291-7 (Apr 2007) ISSN: 1468-2044 England
PMID16547082 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Anti-Bacterial Agents
  • Amoxicillin
Topics
  • Age Distribution
  • Amoxicillin (administration & dosage, therapeutic use)
  • Anti-Bacterial Agents (administration & dosage, therapeutic use)
  • Child, Preschool
  • Developing Countries
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Pneumonia, Bacterial (drug therapy)
  • Treatment Failure
  • Treatment Outcome