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. 2018 Apr 18:4:8.
doi: 10.1186/s40748-018-0076-2. eCollection 2018.

Simplified antibiotic regimens for treating neonates and young infants with severe infections in the Democratic Republic of Congo: a comparative efficacy trial

Adrien Lokangaka  1 , Melissa Bauserman  2 , Yves Coppieters  3 , Cyril Engmann  4 , Shamim Qazi  5 , Antoinette Tshefu  1 , Carl Bose  2
Affiliations

Simplified antibiotic regimens for treating neonates and young infants with severe infections in the Democratic Republic of Congo: a comparative efficacy trial

Adrien Lokangaka et al. Matern Health Neonatol Perinatol. .

Abstract

Background: One-quarter of neonatal and infant deaths are due to infection, and the majority of these deaths occur in developing countries. Standard treatment for infection, which includes parenteral treatment only, is often not available in low-resource settings. Infant mortality will not be reduced in developing countries without a reduction in deaths due to infection. We participated in a multi-site trial that demonstrated the effectiveness of three simplified antibiotic regimens compared to standard treatment (The AFRINEST Trial: parent study). For this report, we examined the site-specific data for the Democratic Republic Congo (DRC), the most impoverished of the countries that participated in the study, to determine if outcomes in the DRC were similar to outcomes across all sites.

Methods: The parent study was an individually randomized, open-label, equivalence trial. Infants with clinical signs of severe infection were randomized to receive one of four regimens: 1) injectable penicillin-gentamicin for 7 days (standard therapy; regimen A), 2) injectable gentamicin and oral amoxicillin for 7 days (regimen B), 3) injectable penicillin-gentamicin for 2 days then oral amoxicillin for 5 days (regimen C), or 4) injectable gentamicin for 2 days and oral amoxicillin for 5 days (regimen D). In the DRC, we enrolled 574 infants, of whom 560 met the per-protocol criteria for analysis of treatment effect. The main outcome was treatment failure within the first week of enrollment.

Results: Treatment failure occurred in 52 (9.3%) infants: 17 (11.6%) with the referent treatment regimen, 13 (9.6%) with regimen B (risk difference [RD] -2.0%; CI -9.2% to 5.2%), 13 (9.0%) with regimen C (RD -2.6%; CI -9.6% to 4.4%), and 9 (6.7%) with regimen D (RD -5.0%; CI -11.7% to 1.7%).

Conclusion: As in the parent study, the risk difference between each of the experimental treatments and the reference treatment suggests equivalence. These findings suggest that the conclusion from the parent study, that a simplified antibiotic regimen can be used for the community-based management of possible severe infection in young infants where referral to a hospital for standard care is often not possible, is true in the DRC. We speculate that the widespread use of a simplified, community-based treatment could result in increased coverage with treatment and improved survival in poor areas.

Trial registration: ACTRN12610000286044 on April 9, 2010.

Keywords: Community-based treatment; Neonatal infection; Simplified antibiotic regimen.

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Conflict of interest statement

This study was approved by the ethics committees at the World Health Organization and the Kinshasa School of Public Health. This study is registered with the Australian New Zealand Clinical Trials Registry on April 9,2010, number ACTRN12610000286044.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT Diagram of Democratic Republic of Congo study cohort. Origin of the study cohort in the Democratic Republic of Congo. The diagram illustrates the origin of the 560 infants whose outcomes were analyzed for treatment effect. Boxes to the right indicate when and why infants were excluded
See this image and copyright information in PMC

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