Effectiveness of serial C-reactive protein point-of-care testing in optimizing antibiotic treatment in neonates and children in Zanzibar: an open-label, individual randomized controlled clinical trial protocol

INTRODUCTION: Antimicrobial resistance is increasing globally. Children are disproportionately affected due to the overuse and misuse of antibiotics which is linked to lack of prompt diagnostics for suspected bacterial infections, limited access to health care facilities and financial constraints. The C-reactive protein (CRP) point-of-care test (POCT) presents an opportunity for quick and cost-effective diagnosis to establish the likelihood of a bacterial infection. However, information on the effectiveness of point-of-care CRP testing in hospitalized children in Zanzibar, Tanzania is limited. METHODS AND ANALYSIS: This multicenter, open-label, individual randomized controlled trial with 28 days follow-up is conducted at four hospitals in Zanzibar. Well-appearing neonates at risk of early onset sepsis, neonates (0 - 28 days) with clinical signs of infection on admission and children (6 months - 12 years) with febrile illness and/or diarrhea on admission are eligible for participation if their caretakers provide informed consent. The hospitals are supplied with CRP POCT equipment as well as a training session on CRP interpretation to aid in the clinical evaluation and antibiotic management of neonates and children. The primary outcome is the duration of antibiotic treatment within 14 days of the admittance of included neonates and children in each study arm and days to relapse of infection (defined as reinstitution of antibiotics within 72 h after completion of treatment). ETHICS AND DISSEMINATION: The study is approved by the Zanzibar Health Research Ethics Committee Ref. No. ZAHREC/04/AMEND/DEC/2023/11. The findings from this study will be used to generate policy briefs and technical reports to inform rational antimicrobial prescriptions' clinical practices and guide future research. Findings will be presented at global conferences and published in peer-reviewed medical journals to foster access to wider communities within Tanzania and beyond. TRIAL REGISTRATION: This trial was registered with ISRCTN registry (ISRCTN25937092) on 22/01/2024.