Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study (TreNTS)
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| ClinicalTrials.gov Identifier: NCT04850677 |
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Recruitment Status :
Recruiting
First Posted : April 20, 2021
Last Update Posted : August 31, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Blood-stream Infections Salmonella Infection Non-Typhoid | Other: Observational Cohort |
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 Type : | Observational |
| Estimated Enrollment : | 3150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study - TreNTS |
| Actual Study Start Date : | August 1, 2021 |
| Estimated Primary Completion Date : | July 31, 2022 |
| Estimated Study Completion Date : | July 31, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Total
All subjects in the study belong to the same group/cohort. As this is an observational study there is no intervention planned.
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Other: Observational Cohort
Observational study |
- 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
- 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) ]In-hospital survival (categorical variable): survival measured between 1st dose of appropriate antibiotics and discharge
- Overall survival [ Time Frame: One month after discharge (no maximum duration of hospitalization) ]Overall survival (time-to-event): survival time measured between 1st dose appropriate antibiotics and one-month post-discharge
- 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) ]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
- 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) ]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
- Microbiological cure [ Time Frame: At day 5 of parenteral treatment ]Microbiological cure (categorical): no growth of NTS BSI in the follow-up blood culture taken at the day 5 of parenteral antibiotics
- Possible disease recurrence [ Time Frame: At one month post-discharge (no maximum period of hospitalization) ]
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
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| Ages Eligible for Study: | up to 5 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Child died and caregiver left the hospital before enrollment
- Child and caregiver left the hospital before enrollment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04850677
| Contact: Natacha Herssens, MSc | +32(0)32470778 | nherssens@itg.be | |
| Contact: Yven Van Herrewege, PhD | yvanherrewege@itg.be |
| Congo, The Democratic Republic of the | |
| Kisantu Hospital | Recruiting |
| Kisantu, Congo, The Democratic Republic of the | |
| Principal Investigator: | Bieke Tack, MD | Institute of Tropical Medicine Antwerp |
| Responsible Party: | Institute of Tropical Medicine, Belgium |
| ClinicalTrials.gov Identifier: | NCT04850677 |
| Other Study ID Numbers: |
ITM202007 |
| First Posted: | April 20, 2021 Key Record Dates |
| Last Update Posted: | August 31, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | 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). |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Infections Communicable Diseases Sepsis Salmonella Infections Disease Attributes Pathologic Processes |
Systemic Inflammatory Response Syndrome Inflammation Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |