Blood-stream InfectionsTreNTSNCT04850677
Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study
An observational study of Blood-stream Infections and Salmonella Infection Non-Typhoid, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 5 years
- Conditions the study is for
- Blood-stream Infections, Salmonella Infection Non-Typhoid
- What is being tested?
- Observational Cohort
- How many people
- 1,884 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Aug 2021to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 5 years
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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.
Who cannot join
- Child died and caregiver left the hospital before enrollment
- Child and caregiver left the hospital before enrollment
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Kisantu Hospital
Kisantu
About this study
Official title: Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study - TreNTS
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.
Read the 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.
- Being tested
- Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational CohortOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Total | All subjects in the study belong to the same group/cohort. As this is an observational study there is no intervention planned. Receives: Other: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
In-hospital survival (categorical variable): survival measured between 1st dose of appropriate antibiotics and discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At one month post-discharge (no maximum period of hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Aug 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood-stream InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,884 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Hôpital St. Luc Kisantu, KU Leuven, International Vaccine Institute
- Responsible party
- Sponsor
- Investigators
- Bieke Tack, MD, Principal investigator, Institute of Tropical Medicine Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850677
- Sponsor's protocol ID
- ITM202007
- Acronym
- TreNTS
- Status last verified
- Sep 2022
- First submitted
- 7 Apr 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sharing procedure for the study will comply with the Institute of Tropical Medicine's data sharing policy on open access to research data. After publishing the manuscript, participant level study data may be shared with other interested users under restricted conditions or made available through an open data repository. These study data will only be shared if the enrolled child are anonymized so that their identity cannot be determined, neither directly nor indirectly. Any subsequent sharing of participant level data will require approval from Institut National de Recherche Biomédicale (INRB) and Institute of Tropical Medicine (ITM).
Publications
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.
PubMed 39871187Tack 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.
PubMed 37903440
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study - TreNTS
- ClinicalTrials.gov ID
- NCT04850677
- Acronym / sponsor ID
- TreNTS / ITM202007
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,884 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Hôpital St. Luc Kisantu, KU Leuven, International Vaccine Institute
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total | – | Other: Observational CohortAll subjects in the study belong to the same group/cohort. As this is an observational study there is no intervention planned. |
Who may qualify
- Ages
- 28 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Child died and caregiver left the hospital before enrollment
- Child and caregiver left the hospital before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational CohortObservational study | Other | Total |
Primary outcome
Clinical failure (fever)
Time frame: up to day 7 after start of appropriate antibiotics
Clinical failure (categorical): composite outcome defined as: - the persistence of tympanic temperature > 37.5°C after 7 days of appropriate antibiotic treatment
Clinical failure (death)
Time frame: from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)
Clinical failure (categorical): composite outcome defined as: - death between the 1st dose of appropriate antibiotics and discharge
6 secondary outcomes
In-hospital survival
Time frame: from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)
Overall survival
Time frame: One month after discharge (no maximum duration of hospitalization)
Time to fever clearance
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
Time frame: from 1st dose of antibiotics until discharge. (maximum period of hospitalization is not defined but is usually maximum 4 weeks)
Microbiological cure
Time frame: At day 5 of parenteral treatment
Possible disease recurrence
Time frame: At one month post-discharge (no maximum period of hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Derived from this study: PubMed 39871187Tack 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.
- Derived from this study: PubMed 37903440Tack 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.
- Individual participant dataSharing planned: Undecided. The data sharing procedure for the study will comply with the Institute of Tropical Medicine's data sharing policy on open access to research data. After publishing the manuscript, participant level study data may be shared with other interested users under restricted conditions or made available through an open data repository. These study data will only be shared if the enrolled child are anonymized so that their identity cannot be determined, neither directly nor indirectly. Any subsequent sharing of participant level data will require approval from Institut National de Recherche Biomédicale (INRB) and Institute of Tropical Medicine (ITM).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bieke Tack, MD principal investigator
Institute of Tropical Medicine Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood-stream Infections and Salmonella Infection Non-Typhoid, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical failure (fever) (time frame: up to day 7 after start of appropriate antibiotics). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04850677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.