Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study

NCT04850677 | Completed

• 1 other identifier: ITM202007
• Study Type: observational
• Target: 1,884
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood-stream Infections; Salmonella Infection Non-Typhoid

Outcome Measures

Primary Outcomes (2)

• 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

  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

  from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)

Secondary Outcomes (6)

• In-hospital survival

  from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)

• Overall survival

  One month after discharge (no maximum duration of hospitalization)

• Time to fever clearance

  from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)

• Length of hospital stay

  from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)

• Microbiological cure

  At day 5 of parenteral treatment

Study Arms (1)

Total

All subjects in the study belong to the same group/cohort. As this is an observational study there is no intervention planned.

Other: Observational Cohort

Interventions

Observational Cohort OTHER

Observational study

Total

Eligibility Criteria

• Age: 28 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• Be a child \> 28 days and \< 5 years old
• Be admitted to Kisantu Hospital
• Have a blood culture sampled upon hospital admission
• Having a caregiver willing and able to provide written informed consent, which will be requested as soon as possible after screening of the other three eligibility criteria. By consenting with study participation of the child, the caregiver agrees to that the child participates in the study procedures at presentation in the hospital, during hospital admission and during 1 month after discharge.

You may not qualify if:

• Child died and caregiver left the hospital before enrollment
• Child and caregiver left the hospital before enrollment

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• Hôpital St. Luc Kisantu: collaborator
• KU Leuven: collaborator
• International Vaccine Institute: collaborator

Study Sites (1)

Kisantu Hospital

Kisantu, Democratic Republic of the Congo

Location

Related Publications (2)

• Tack B, Vita D, Mbuyamba J, Ntangu E, Vuvu H, Kahindo I, Ngina J, Luyindula A, Nama N, Mputu T, Im J, Jeon H, Marks F, Toelen J, Lunguya O, Jacobs J, Van Calster B. Developing a clinical prediction model to modify empirical antibiotics for non-typhoidal Salmonella bloodstream infection in children under-five in the Democratic Republic of Congo. BMC Infect Dis. 2025 Jan 27;25(1):122. doi: 10.1186/s12879-024-10319-x.

  PMID: 39871187 DERIVED

• Tack B, Vita D, Ntangu E, Ngina J, Mukoko P, Lutumba A, Vangeluwe D, Toelen J, Allegaert K, Lunguya O, Ravinetto R, Jacobs J. Challenges of Antibiotic Formulations and Administration in the Treatment of Bloodstream Infections in Children Under Five Admitted to Kisantu Hospital, Democratic Republic of Congo. Am J Trop Med Hyg. 2023 Oct 30;109(6):1245-1259. doi: 10.4269/ajtmh.23-0322. Print 2023 Dec 6.

  PMID: 37903440 DERIVED

Study Officials

• Bieke Tack, MD

  Institute of Tropical Medicine Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 20, 2021
• Study Start: August 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

DE (1)