Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study
Condition: Blood-stream Infections; Salmonella Infection Non-Typhoid
MeSH terms: Infections; Communicable Diseases; Sepsis; Salmonella Infections
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Observational Cohort
Intervention type(s): Other
Intervention description(s): Observational study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between 28 days and 5 years that are admitted to the Kisantu hospital with a need
        for a blood sample culture (suspicion of a blood-stream infection).