RT Journal Article
SR Electronic
T1 Azithromycin to prevent post-discharge morbidity and mortality in Kenyan children: a protocol for a randomised, double-blind, placebo-controlled trial (the Toto Bora trial)
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e019170
DO 10.1136/bmjopen-2017-019170
VO 7
IS 12
A1 Patricia B Pavlinac
A1 Benson O Singa
A1 Grace C John-Stewart
A1 Barbra A Richardson
A1 Rebecca L Brander
A1 Christine J McGrath
A1 Kirkby D Tickell
A1 Mary Amondi
A1 Doreen Rwigi
A1 Joseph B Babigumira
A1 Sam Kariuki
A1 Ruth Nduati
A1 Judd L Walson
YR 2017
UL http://bmjopen.bmj.com/content/7/12/e019170.abstract
AB Introduction Child mortality due to infectious diseases remains unacceptably high in much of sub-Saharan Africa. Children who are hospitalised represent an accessible population at particularly high risk of death, both during and following hospitalisation. Hospital discharge may be a critical time point at which targeted use of antibiotics could reduce morbidity and mortality in high-risk children.Methods and analysis In this randomised, double-blind, placebo-controlled trial (Toto Bora Trial), 1400 children aged 1–59 months discharged from hospitals in Western Kenya, in Kisii and Homa Bay, will be randomised to either a 5-day course of azithromycin or placebo to determine whether a short course of azithromycin reduces rates of rehospitalisation and/or death in the subsequent 6-month period. The primary analysis will be modified intention-to-treat and will compare the rates of rehospitalisation or death in children treated with azithromycin or placebo using Cox proportional hazard regression. The trial will also evaluate the effect of a short course of azithromycin on enteric and nasopharyngeal infections and cause-specific morbidities. We will also identify risk factors for postdischarge morbidity and mortality and subpopulations most likely to benefit from postdischarge antibiotic use. Antibiotic resistance in Escherichia coli and Streptococcus pneumoniae among enrolled children and their primary caregivers will also be assessed, and cost-effectiveness analyses will be performed to inform policy decisions.Ethics and dissemination Study procedures were reviewed and approved by the institutional review boards of the Kenya Medical Research Institute, the University of Washington and the Kenyan Pharmacy and Poisons Board. The study is being externally monitored, and a data safety and monitoring committee has been assembled to monitor patient safety and to evaluate the efficacy of the intervention. The results of this trial will be published in peer-reviewed scientific journals and presented at relevant academic conferences and to key stakeholders.Trial registration number NCT02414399.