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Journal of Tropical Pediatrics Advance Access published online on July 8, 2008
Journal of Tropical Pediatrics, doi:10.1093/tropej/fmn050
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© The Author [2008]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Effectiveness of 3-Day Amoxycillin vs. 5-Day Co-trimoxazole in the Treatment of Non-severe Pneumonia in Children Aged 2–59 Months of Age: A Multi-centric Open Labeled Trial

Shally Awasthia, Girdhar Agarwalb, J. V. Singha, S. K. Kabrac, R. M. Pillaid, Sunit Singhie, Baridalyne Nongkynrihc, Rashmi Dwivedif, Vaishali B. Moreg, Madhuri Kulkarnig, A. K. Niswadeh, Bhavneet Bharti, Ankur Ambasta, Puneet Dhasmanaa and ICMR-IndiaClen Pneumonia Project Group *

aKing George's Medical University, Lucknow, India
bLucknow University, Lucknow, India
cAll India Institute of Medical Sciences, New Delhi, India
dGovernment Medical College, Trivandrum, India
ePost Graduate Institute of Medical Sciences, Chandigarh, India
fGandhi Medical College, Bhopal, India
gLok Manya Tilak Medical College, Mumbai, India
hGovernment Medical College, Nagpur, India

Correspondence: Prof. Shally Awasthi, Department of Pediatrics, King George's Medical University, Lucknow. E-mail <sawasthi{at}sancharnet.in>.


  Abstract

This cluster randomized, open labeled trial was conducted to compare the effectiveness of 3 days of oral amoxycillin and 5 days of co-trimoxazole treatment in terms of clinical failure in children with World Health Organization (WHO) defined non-severe pneumonia in primary health centers in rural India. Participants were children aged 2–59 months with WHO defined non-severe pneumonia, with or without wheeze, who were accessible to follow up. From seven primary health centers in each arm, 2009 cases were randomized, 993 and 1016 in treatment with amoxycillin and co-trimoxazole, respectively. Fever was present in 1247 (62.1%) and wheeze in 443 (22.1%). There was good adherence and low loss to follow-up. Clinical failure on amoxycillin and co-trimoxazole on intention to treat analysis was 137 and 97, respectively (absolute difference = 0.04, 95% confidence interval: – 0.035–0.12). We conclude that there was no difference in effectiveness of oral co-trimoxazole or amoxycillin in treating non-severe pneumonia.

*The members of ICMR-IndiaClen Pneumonia Project Group are listed in Appendix.


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