With this study the researchers aim to provide observational data on the treatment efficacy of currently used antibiotic treatment regimens for NTS BSI in hospital-admitted children. The study is an observational cohort study where the antibiotic treatments used and treatment outcomes in the St. Luc general referral hospital in Kisantu health zone (Province Kongo Central, DR Congo) will be described.
In sub-Saharan Africa, non-typhoidal Salmonella (NTS) are a frequent cause of bloodstream infection (BSI) in young children, display high levels of antibiotic resistance and have a high case fatality rate (15%). In Kisantu hospital in the Democratic Republic of Congo (DR Congo), NTS account for 75% of blood culture pathogens in young children. Currently, NTS BSI are mostly treated with third generation cephalosporins or fluoroquinolones. However, resistance to these antibiotics is emerging in NTS BSI. Third generation cephalosporine and fluoroquinolone resistant Salmonella are identified as critical priority pathogens by the World Health Organization (WHO). To combat the developing antimicrobial resistance, rational and evidence-based antibiotic treatment of NTS BSI is crucial. So far, there are no guidelines to treat NTS BSI in a low-resource setting. The currently used antibiotic regimens are experience-based or extrapolated from typhoid fever. The absence of dedicated studies addressing antibiotic treatment efficacy in NTS BSI in sub-Saharan African children hampers the development of evidence-based antibiotic treatment guidelines and antibiotic stewardship. Clinical practice guidelines established for high- and middle-income countries recommend 7 - 14 days of parenteral antibiotic treatment for NTS BSI. In sub-Saharan Africa however, financial, logistic and nursing care barriers preclude such long parenteral treatment regimens. To decrease the case fatality and combat antibiotic resistance of NTS BSI in its most affected population (i.e. children in sub-Saharan Africa), data that support appropriate antibiotic treatment (i.e. antibiotic class, dose, route and duration) are urgently needed. The researchers aim to provide observational data on the treatment efficacy of currently used antibiotic treatment regimens for NTS BSI in hospital-admitted children. They hypothesize that, in terms of treatment efficacy in hospital admitted children with NTS BSI, a short course of parenteral antibiotics (\<7 days) with switch to oral antibiotics is not inferior to a full parenteral antibiotic course (≥7 days). This study is designed as a prospective, single-center, hospital-based observational study on the efficacy of antibiotic treatment of a cohort of young children (1 month to 5 years old) with NTS BSI. Data will be collected from the enrolled children during three different study phases, i.e., upon admission, daily in-hospital follow-up and post-discharge follow-up.
Observational study
Kisantu Hospital
Kisantu, Democratic Republic of the Congo
Clinical failure (fever)
Clinical failure (categorical): composite outcome defined as: \- the persistence of tympanic temperature \> 37.5°C after 7 days of appropriate antibiotic treatment
Time frame: up to day 7 after start of appropriate antibiotics
Clinical failure (death)
Clinical failure (categorical): composite outcome defined as: \- death between the 1st dose of appropriate antibiotics and discharge
Time frame: from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)
In-hospital survival
In-hospital survival (categorical variable): survival measured between 1st dose of appropriate antibiotics and discharge
Time frame: from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)
Overall survival
Overall survival (time-to-event): survival time measured between 1st dose appropriate antibiotics and one-month post-discharge
Time frame: One month after discharge (no maximum duration of hospitalization)
Time to fever clearance
Time to fever clearance (time-to-event): fever clearance is defined as a tympanic temperature ≤37.5°C for at least 2 days \[15-17\], measured between 1st dose appropriate antibiotics and discharge
Time frame: from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)
Length of hospital stay
Length of hospital stay (time-to-event): number of days that the child was admitted to the hospital, measured between moment of admission and discharge
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Study Type
OBSERVATIONAL
Enrollment
1,884
Time frame: from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)
Microbiological cure
Microbiological cure (categorical): no growth of NTS BSI in the follow-up blood culture taken at the day 5 of parenteral antibiotics
Time frame: At day 5 of parenteral treatment
Possible disease recurrence
Possible disease recurrence: * Fever recurrence: reappearance of objective (measured temperature \> 37.5°C) or subjective fever according to the caregiver, measured between moment of fever clearance and one-month post-discharge * All-cause hospital readmission: readmission at a hospital or health center irrespective of the cause of readmission, measured between discharge and one-month post-discharge * All-cause care seeking at health care facilities: consultation of any health care facility (traditional, private or official) irrespective of the reason for consultation, measured between discharge and one-month post-discharge * Re-initiation of antibiotics or antimalarials: start of antibiotic or antimalarial treatment after stop of antibiotic treatment for NTS BSI irrespective of the reason for treatment, measured between last dose of appropriate antibiotics and one-month post-discharge
Time frame: At one month post-discharge (no maximum period of hospitalization)