Possible serious bacterial infections (PSBI), or sepsis, accounts for 23 percent of newborn deaths in low and middle income countries.1,2 The “gold standard” treatment – hospitalization and 7-10 days of injectable antibiotics – is often not feasible in low resource settings. In 2007, the Health Research Program and partners convened a global consultation to review evidence on home-based therapies for PSBI treatment. Experts determined there was insufficient evidence to recommend home-based treatment and that further research was needed.
As part of a series of coordinated clinical trials, USAID conducted a trial in Bangladesh to compare a combination of simple regimens to the standard treatment. Similar trials were conducted in five other African and Asian countries. Results from these studies published in 2013 indicated that infants with clinical severe infections could be treated effectively with simpler regimens administered by trained health workers when hospitalization was not possible.3, 4,5
Based on these findings, WHO released new guidelines on the treatment of PSBI in 2015 and convened meetings in several countries to orient policy makers and select local implementation sites. Technical support units were also established in seven countries in Africa and Asia, including Bangladesh. In August 2016, the Health Research Program issued an Addendum to the Global Health Broad Agency Announcement, soliciting Expressions of Interest for implementation research to support introduction of of the simplified regimen in real-world settings.
Using Bangladesh as an example, the country adopted a new PSBI treatment policy in 2013. The research-to-practice process began by engaging policy leaders to support neonatal sepsis management scale-up, forming working groups, disseminating research results, and advocating for a national PSBI guideline that incorporated a simplified treatment regimen. The Health Research Program then supported implementation research in three sites to identify coverage, quality, and operational challenges, and solutions for effectively implementing the new guidelines. Results from the studies will inform planning for the scale-up of PSBI management in Bangladesh.6
The Health Research Program’s work on PSBI treatment is a model for accelerating research-to-use. The strong collaborative partnership established early on between USAID, WHO, UNICEF, Bill and Melinda Gates Foundation, and Save the Children informed global policy change and country level action on the treatment of PSBI in newborns. As noted by Steve Wall, Senior Advisor for Newborn Health, Save the Children, during the Health Research Program’s End of Project Symposium in Washington DC in July 2016, “this kind of partnership produced results that are interpretable and able to lead to global health policy change much more quickly…”
Visit the HRCI project page for more information about the Simplified Antibiotic Treatment (SAT) trial on neonatal sepsis in Bangladesh. Another good resource on PSBI and related newborn health issues is the Healthy Newborn Network.
Check out this video to learn more about newborn sepsis.
- Liu L, Oza S, Hogan D, et. al. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40.
- Wall, S. (2016). Rationale for simplified antibiotic regimens for newborn infection. Health Research Program End of Project Symposium [PowerPoint Slides].
- Baqui, A. H., Saha, S. K., Ahmed, A. S. M. N. U., Shahidullah, M., Quasem, I., Roth, D. E., … Black, R. E. (2013). Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Serious Infection in Neonates and Young Infants 0–59 Days of Age in Bangladesh: Design of a Randomized Controlled Trial. The Pediatric Infectious Disease Journal, 32(Suppl 1 Innovative Treatment Regimens for Severe Infections in Young Infants), S12–S18. http://doi.org/10.1097/INF.0b013e31829ff790
- African Neonatal Sepsis Trial (AFRINEST) group, Tshefu, A, Lokangaka, A et al. Simplified antibiotic regimens compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with clinical signs of possible serious bacterial infection when referral is not possible: a randomised, open-label, equivalence trial. Lancet. 2015; 385: 1767–1776. http://dx.doi.org/10.1016/ S0140-6736(14)62284-4
- Baqui, A. (2016). AFRINEST AND SATT: Design, Findings, Conclusions. HaRP End of Project Meeting. [Power Point Slides].
- Shahidullah, M., El Arifeen, S., Rubayet, S. (2016). PSBI Management of Newborn and Young Infant: Bangladesh. HaRP End of Project Meeting. [Power Point Slides].