dc.contributor.author | Agweyu, A | |
dc.contributor.author | Gathara, D | |
dc.contributor.author | Muinga, N | |
dc.contributor.author | Edwards, T | |
dc.contributor.author | Allen, E | |
dc.contributor.author | Maleche-Obimbo, E | |
dc.contributor.author | English, M | |
dc.contributor.author | English M;, On behalf of the Severe Pneumonia Study Group. | |
dc.date.accessioned | 2015-01-02T08:00:35Z | |
dc.date.available | 2015-01-02T08:00:35Z | |
dc.date.issued | 2014-12-30 | |
dc.identifier.citation | Clin Infect Dis. 2014 Dec 30. pii: ciu1166. | en_US |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/pubmed/25550349 | |
dc.identifier.uri | http://hdl.handle.net/11295/78706 | |
dc.description.abstract | BACKGROUND:
There are concerns that the evidence from studies showing non-inferiority of oral amoxicillin to benzyl penicillin for severe pneumonia may not be generalizable to high mortality settings.
METHODS:
An open-label multicenter randomized controlled non-inferiority trial was conducted at six Kenyan hospitals. Eligible children aged 2 - 59 months were randomized to receive amoxicillin or benzyl penicillin and followed up for the primary outcome of treatment failure at 48 hours. A non-inferiority margin of risk difference between amoxicillin and benzyl penicillin groups was pre-specified at 7%.
RESULTS:
We recruited 527 children including 302 (57.3%) with co-morbidity. Treatment failure was observed in 20/260 (7.7%)and 21/261 (8.0%) of patients in the amoxicillin and benzyl penicillin arms respectively (risk difference -0.3%, 95% confidence interval (CI) -5.0 to 4.3) in per protocol analyses. These findings were supported by the results of intention to treat analyses. Treatment failure by day 5 post-enrolment was 11.4% and 11.0% and rising to 13.5% and 16.8% by day 14 in the amoxicillin versus benzyl penicillin groups respectively. The most frequent cause of cumulative treatment failure at day 14 was clinical deterioration within 48 hours of enrolment (33/59; 55.9%). Four patients died (overall mortality 0.8%) during the study, three of whom were allocated to the benzyl penicillin group. The presence of wheeze was independently associated with less frequent treatment failure.
CONCLUSIONS:
Our findings confirm non-inferiority of amoxicillin to benzyl penicillin, provide estimates of risk of treatment failure in Kenya and offer important additional evidence for policy making in sub-Saharan Africa. | en_US |
dc.language.iso | en | en_US |
dc.publisher | University of Nairobi | en_US |
dc.title | Oral Amoxicillin versus Benzyl Penicillin for Severe Pneumonia among Kenyan Children: A Pragmatic Randomized Controlled Non-inferiority Trial. | en_US |
dc.type | Article | en_US |
dc.type.material | en | en_US |