TY - JOUR
T1 - A randomized controlled trial of hospital versus home based therapy with oral amoxicillin for severe pneumonia in children aged 3 - 59 months
T2 - The IndiaCLEN Severe Pneumonia Oral Therapy (ISPOT) Study
AU - ISPOT Study Group
AU - Patel, Archana B.
AU - Bang, Akash
AU - Singh, Meenu
AU - Dhande, Leena
AU - Chelliah, Luke Ravi
AU - Malik, Ashraf
AU - Khadse, Sandhya
AU - Agrawal, Gopal
AU - Charde, Girish
AU - Pandit, Sadbhawna
AU - Ray, Pallab
AU - Agarwal, Amit
AU - Ravichandran, C.
AU - Meeran, Md
AU - Suresh, Saradha
AU - Jain, Manish
AU - Vilhekar, Krushna
AU - Mendiratta, Deepak
AU - Khairkar, Vijayshree
AU - Firdaus, Uzma
AU - Rizvi, Meher
AU - Valvi, Chhaya
N1 - Publisher Copyright:
© 2015 Patel et al.
PY - 2015/11/17
Y1 - 2015/11/17
N2 - Background: Pneumonia is the leading cause of child mortality under five years of age worldwide. For pneumonia with chest indrawing in children aged 3-59 months, injectable penicillin and hospitalization was the recommended treatment. This increased the health care cost and exposure to nosocomial infections. We compared the clinical and cost outcomes of a seven day treatment with oral amoxicillin with the first 48 h of treatment given in the hospital (hospital group) or at home (home group). Methods: We conducted an open-label, multi-center, two-arm randomized clinical trial at six tertiary hospitals in India. Children aged 3 to 59 months with chest indrawing pneumonia were randomized to home or hospital group. Clinical outcomes, treatment adherence, and patient safety were monitored through home visits on day 3, 5, 8, and 14 with an additional visit for the home group at 24 h. Clinical outcomes included treatment failure rates up to 7 days (primary outcome) and between 8-14 days (secondary outcome) using the intention to treat and per protocol analyses. Cost outcomes included direct medical, direct non-medical and indirect costs for a random 17 % subsample using the micro-costing technique. Results: 1118 children were enrolled and randomized to home (n = 554) or hospital group (n = 564). Both groups had similar baseline characteristics. Overall treatment failure rate was 11.5 % (per protocol analysis). The hospital group was significantly more likely to fail treatment than the home group in the intention to treat analysis. Predictors with increased risk of treatment failure at any time were age 3-11 months, receiving antibiotics within 48 h prior to enrolment and use of high polluting fuel. Death rates at 7 or 14 days did not differ significantly. (Difference -0.0 %; 95 % CI -0.5 to 0.5). The median total treatment cost was Rs. 399 for the home group versus Rs. 602 for the hospital group (p < 0.001), for the same effect of 5 % failure rate at the end of 7 days of treatment in the random subsample. Conclusions: Home based oral amoxicillin treatment was equivalent to hospital treatment for first 48 h in selected children of chest indrawing pneumonia and was cheaper. Consistent with the recent WHO simplified guidelines, management with home based oral amoxicillin for select children with only fast breathing and chest-indrawing can be a cost effective intervention.
AB - Background: Pneumonia is the leading cause of child mortality under five years of age worldwide. For pneumonia with chest indrawing in children aged 3-59 months, injectable penicillin and hospitalization was the recommended treatment. This increased the health care cost and exposure to nosocomial infections. We compared the clinical and cost outcomes of a seven day treatment with oral amoxicillin with the first 48 h of treatment given in the hospital (hospital group) or at home (home group). Methods: We conducted an open-label, multi-center, two-arm randomized clinical trial at six tertiary hospitals in India. Children aged 3 to 59 months with chest indrawing pneumonia were randomized to home or hospital group. Clinical outcomes, treatment adherence, and patient safety were monitored through home visits on day 3, 5, 8, and 14 with an additional visit for the home group at 24 h. Clinical outcomes included treatment failure rates up to 7 days (primary outcome) and between 8-14 days (secondary outcome) using the intention to treat and per protocol analyses. Cost outcomes included direct medical, direct non-medical and indirect costs for a random 17 % subsample using the micro-costing technique. Results: 1118 children were enrolled and randomized to home (n = 554) or hospital group (n = 564). Both groups had similar baseline characteristics. Overall treatment failure rate was 11.5 % (per protocol analysis). The hospital group was significantly more likely to fail treatment than the home group in the intention to treat analysis. Predictors with increased risk of treatment failure at any time were age 3-11 months, receiving antibiotics within 48 h prior to enrolment and use of high polluting fuel. Death rates at 7 or 14 days did not differ significantly. (Difference -0.0 %; 95 % CI -0.5 to 0.5). The median total treatment cost was Rs. 399 for the home group versus Rs. 602 for the hospital group (p < 0.001), for the same effect of 5 % failure rate at the end of 7 days of treatment in the random subsample. Conclusions: Home based oral amoxicillin treatment was equivalent to hospital treatment for first 48 h in selected children of chest indrawing pneumonia and was cheaper. Consistent with the recent WHO simplified guidelines, management with home based oral amoxicillin for select children with only fast breathing and chest-indrawing can be a cost effective intervention.
KW - Cost effective
KW - Hospitalization
KW - Lower chest indrawing
KW - Oral amoxicillin
KW - Randomizedtrial
KW - Severe pneumonia
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U2 - 10.1186/s12887-015-0510-9
DO - 10.1186/s12887-015-0510-9
M3 - Article
C2 - 26577943
AN - SCOPUS:84946963018
SN - 1471-2431
VL - 15
JO - BMC Pediatrics
JF - BMC Pediatrics
IS - 1
M1 - 186
ER -