Session: Simplified Antibiotic Regimens for Newborns and Young Infants Without Access to Hospital Treatment: New Global Evidence and Implications for Countries
Presenter: Wammanda Robinson, Ahmadu Bello University/Ahmadu Bello University Teaching Hospital
There is a need to evaluate simpler antibiotics to be used in young infants with possible severe bacterial infection when referral is not possible. In an open-label equivalence trial in DR Congo, Kenya, and Nigeria, newborns and young infants (0-59 days) with signs of clinically severe infection, classified by a study nurse, were eligible for enrollment if families refused hospitalization. Enrolled babies were randomly assigned to receive one of the four treatment regimens: injectable procaine benzylpenicillin–gentamicin for 7 days (A); injectable gentamicin and oral amoxicillin for 7 days (B); injectable procaine benzylpenicillin–gentamicin for 2 days, then oral amoxicillin for 5 days (C); or injectable gentamicin for 2 days and oral amoxicillin for 7 days (D) on outpatient basis. Primary outcome was treatment failure by day 8 after enrollment, no improvement by day 4, or not cured by day 8. Independent assessors evaluated study outcomes on days 4, 8, 11 and 15. Pre-speciﬁed similarity margin of 5% was used. 894, 884, 896 and 890 were assigned to groups A, B, C and D respectively. 67 (8%) infants failed treatment in group A compared with 51 (6%) infants in group B (risk diﬀerence –1•9%, 95% CI –4•4 to 0•1), 65 (8%) in group C (–0•6%, –3•1 to 2•0), and 46 (5%) in group D (–2•7%, –5•1 to 0•3). Treatment failure in groups B, C, and D was within the similarity margin compared with group A. During the 15 days after random allocation, 12 (1%) infants died in group A, compared with ten (1%) infants in group B, 20 (2%) infants in group C, and 11 (1%) infants in group D. The three simpler regimens were as eﬀective as injectable procaine benzylpenicillin–gentamicin for 7 days on an outpatient basis.