1. This randomized, open-label, equivalence trial showed that for treatment of young infants with fast breathing as the only clinical sign of serious infection, and for whom referrals to a hospital were not possible, oral amoxicillin was as effective as injectable procaine benzylpenicillin-gentamicin.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The World Health Organization recommends young infants be referred to a hospital when serious bacterial infection is suspected. However, in many developing countries where health care resources are scarce, this is not always possible. This study assessed whether treatment with oral amoxicillin for treatment of infants with fast breathing as the only clinical sign of serious bacterial infection was as effective as standard treatment, when referral to a hospital is not possible. At sites in DR Congo, Kenya, and Nigeria young infants with fast breathing in the absence of other clinical signs of serious infection were allocated to a group treated for seven days with either oral amoxicillin twice daily or injectable procaine benzylpenicillin-gentamicin once per day. With treatment failure as the primary endpoint, oral amoxicillin was found to be as effective as the injectable treatment of young infants with fast breathing as the only clinical sign of serious infection. A major strength of this study was its high rate of follow-up.
The study was funded by Bill & Melinda Gates Foundation grant to WHO.
Click to read the study in The Lancet Global Health
Relevant Reading: Oral amoxicillin versus injectable penicillin for severe pneumonia in children aged 3 to 59 months: a randomised multicentre equivalency study
In-Depth [randomized controlled trial]: This randomized, open-label, equivalence trial sought to analyze the efficacy of oral amoxicillin in infants with fast breathing as the only clinical sign of serious infection when referral was not possible. From April 2011 to March 2013, 3,267 infants aged 0-59 days were included in analysis to compare efficacy of the oral amoxicillin to standard treatment with injectable procaine benzylpenicillin-gentamicin when referral to a hospital was not an option, at sites in DC Congo, Kenya, and Nigeria. To be included, infants needed to have fast breathing in the absence of other clinical signs. Infants were excluded if predetermined signs of critical illness were present.
Primary outcome was treatment failure by day eight of treatment defined as clinical deterioration, development of a serious adverse event (death), no improvement by day four, or not cured by day eight. In the procaine benzylpenicillin group, 234 infants (22%) infants failed treatment compared to 221 (19%) infants in the oral amoxicillin group (risk difference -2.6%, 95% CI -6.0 to 0.8). For treatment of infants with fast breathing as the only clinical sign of serious infection, oral amoxicillin was found to be as effective as injectable procaine benzylpenicillin-gentamicin when referral to a hospital was not possible.
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