Influence of HIV status on outcomes of children admitted with sepsis at a paediatric hospital in Zambia: protocol for a prospective longitudinal study.

Introduction: Sepsis, a condition of global public health concern, is a major cause of morbidity and mortality, especially in patients with underlying HIV infection. This study aims to determine outcomes, aetiology and antibiotic resistance patterns among children with HIV exposure or infection admitted with a clinical presentation suggestive of sepsis who have confirmed bloodstream infections at Arthur Davison Children's Hospital (ADCH) in Ndola, Zambia.

Methods And Analysis: This will be a prospective longitudinal study of 200 children aged <2 years admitted with sepsis at ADCH with two of the following conditions: temperature of 38.0°C, respiratory rate ≥20 breaths per minute and pulse rate ≥90 beats per minute. About 2-5 mL of blood collected from each participant will be inoculated into BACTEC culture bottles and incubated for 5-7 days. Positive cultures will be inoculated onto culture media for subculture followed by species identification followed by antibiotic susceptibility testing. Time-to-event outcomes such as hospital readmission and mortality will be analysed using Kaplan-Meier and Cox proportional hazards. Predictors will be identified using regression methods. All statistical tests will use a 5% significance level with a 95% confidence level. STATA V.16 will be used for statistical analysis.

Ethics And Dissemination: Ethical clearance and approval have been granted by the Tropical Diseases Research Centre Ethics Committee (TDRC-EC 092/07/23). Caregiver consent will be obtained verbally for participants presenting as medical emergencies, and written informed consent will be obtained once stable. Findings from this study will be shared with the Ministry of Health Zambia and will be disseminated to the scientific community through peer-reviewed scientific journals.