Investigation of clinical, epidemiological, and genomic landscape of healthcare-associated infections in Malawi: a study protocol for a prospective longitudinal cohort

Background Healthcare-associated infections (HCAI) represent a pressing global health concern, with each country and healthcare setting facing distinct challenges. In African countries, the emergence of antimicrobial resistance (AMR), especially to third-generation cephalosporins amongst Enterobacterales (3GCR-E) is particularly severe given the widespread dependence on ceftriaxone as a first-line treatment for severe infections. The burden of HCAI is not yet adequately described. This study aims to address this gap in Malawi, by estimating the attributable mortality and morbidity associated with HCAI and associated AMR. Methods This is a prospective longitudinal cohort targeting three HCAI syndromes: surgical site infection, bloodstream infection, and catheter-associated urinary tract infection. We aim to recruit 600 adult (≥ 18 years) patients (300 with HCAI and 300 without HCAI) in three selected healthcare facilities in Malawi. Clinical variables are collected at enrolment, hospital discharge, and at day 30, 90 and 180 post-discharge using electronic case report forms. Mortality, extra length of hospital stay, and other health outcomes will be compared between patients with (drug-resistant or susceptible) HCAI and those without HCAI. Discussion The results of this study will contribute to understanding the burden of HCAI and AMR in Malawi. This information will help the infection prevention and control programme leads at facility level and policy-makers nationally, whilst providing regionally relevant insight into HCAI.