1. This randomized, open label, equivalence trial showed that an outpatient combination of parenteral and oral antibiotic therapy was equally as effective and safe as standard parenteral treatment for neonates and young infants with severe infections.
2. Decreasing the number of injections required for outpatient treatment of severe infantile infection may lead to broadened treatment options and enhanced access to care in resource-poor areas.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Infection accounts for nearly one quarter of neonatal death worldwide. In under-developed areas of the world where birth takes place in the home and often with the assistance of an unskilled attendant, the chance for introduction of an infectious agent early in life is high. In resource-poor areas of the world it is often difficult, unacceptable, or impossible for parents or caregivers to access healthcare treatment in a hospital or formal environment. This necessitates that treatment for infections must be delivered in a manner suitable for outpatient treatment. This study sought to identify whether two alternate mixed oral/parenteral antibiotic treatment regimens with fewer injections were as effective as the standard seven day parenteral antibiotic treatment regimen of penicillin (or amoxicillin) and gentamicin currently recommended for neonates with severe infections.
The results showed that the two alternate mixed oral/parenteral antibiotic treatments in the outpatient setting were as effective as the current standard regimen. Additionally, death rates and non-fatal relapse rates were similar in all three groups. This study was strengthened by the inclusion of both urban and rural populations, suggesting that these treatments are effective in a wide range of settings, by the incorporation of validity controls in the form of a blinded second physician assessor to corroborate findings found by the primary physician treating each infant. The study, however, was weakened by the fact that the primary physician was not blinded to group assignment and that there were very few infants between the ages of 0-6 days, which limits the applicability of the study for this population.
In-Depth [randomized controlled trial]: This study included 2,490 infants aged 0-59 days from rural and urban sites in Bangladesh with signs of severe infection (lower chest wall indrawing, axillary temperature >38.0°C or <35.5°C, lethargy, or history of feeding problems). These infants were randomly assigned to one of three groups to receive outpatient antibiotic treatment for their illness. Treatment groups consisted of A) standard treatment of intramuscular procaine benzylpenicillin and gentamicin once daily for 7 days (n=795), B) alternative treatment with intramuscular gentamicin once daily and oral amoxicillin twice daily for 7 days (n=782), or C) alternative treatment with intramuscular procaine benzylpenicillin and gentamicin once daily for 2 days, followed by oral amoxicillin twice daily for 5 days (n=790). Treatment failure in seven days was the primary outcome assessed.
The results showed that 78 (10%) infants in group A had treatment failure while 65 (8%) and 64 (8%) of infants in groups B and C, respectively, had treatment failure (risk difference B:A -1.5%, 95% Confidence Interval [CI] -4.3 to 1.3) and (C:A -1.7%, -4.5 to 1.1). Death rates were similar in all three groups, as were non-fatal relapse rates.
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