Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal
Study Details
Study Description
Brief Summary
This trial aims to validate a novel clinical care strategy based on a electronic clinical decision support algorithm (CDSA) combined with point of care rapid diagnostic tests by evaluating its impact on antibiotic prescription and clinical outcome of children and adolescent presenting at primary healthcare facilities with non-severe acute illness compared to routine practice. The trial also aims to assess the usability of the CDSA strategy. The study will be conducted in primary healthcare facilities across different epidemiological regions of Senegal.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CDSA strategy Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers trained on the CDSA strategy |
Other: Patient clinical management based on the CDSA strategy
The CDSA strategy is a combination of point of care tests (rapid diagnostic tests targeting malaria, dengue fever and streptococcus group a sore through) and a mHealth tool that provides patient management recommendations, including treatment, based on an algorithm integrating patient clinical signs and symptoms, history and diagnostic test results.
|
| No Intervention: Routine practice Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers according to routine practice at the health facility |
Outcome Measures
Primary Outcome Measures
- Non-inferiority of the CDSA strategy when compared to routine practice in terms of clinical status assessed at Day 7 [4 months]
This will be measured as point estimates of the percent change of patient with resolved illness at Day 7 in the intervention arm, as compared to the control arm.
- Superiority of the CDSA strategy when compared to routine practice in terms of antibiotic prescription at Day 0 [4 months]
This will be measured as point estimates of the percent change of antibiotic prescription at Day 0 in the intervention arm, as compared to the control arm and to site-specific historical data. This measure aims to assess rational use of antibiotics using the CDSA strategy compared to routine practice.
Secondary Outcome Measures
- Antibiotic prescription rate during 7 days of follow-up in the intervention arm compared to the control arm [4 months]
This measure will further assess rational antibiotic prescribing using the CDSA strategy compared to routine practice.
- Diagnostic performance of the dengue rapid diagnostic test (RDT) [4 months]
The performance of the dengue RDT used in health facilities will be assessed against reference standards.
- Identification of risk factors associated with viral and bacterial infections [4 months]
This measure aims to better characterize viral and bacterial infections in children and adolescents presenting with acute illness in these settings and improve the next version of the algorithm.
Other Outcome Measures
- Usability of the CDSA strategy [4 months]
This measure will determine the ease of use of the CDSA strategy. This will be assessed through questionnaires administered to end users at the beginning and end of participant inclusion; the assessment of data completeness comparing historical collected-on-paper to study data; and passive collection of the platform performance indicators autogenerated by the platform.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ongoing fever or diarrhea
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ongoing fever will be defined objectively or as a reported fever, defined as : axillary temperature ≥37.5°C or tympanic, oral or rectal temperature ≥38.0°C; and fever duration ≤ 10 days
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ongoing diarrhea will be defined as at least 3 abnormal stools during the last 24hrs
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First consultation for the current illness
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Feasibility of contact between the patient (or his/her designated relative) and the study team at day 3 and day 7
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Written informed consent by the caretaker/legally acceptable representative
Exclusion Criteria:
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Infants less than 6 months of age
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Age ≥ 15 years
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Clinical status requiring immediate transfer to an appropriate care facility/ severe illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PS Ndiaye-Fatick | Fatick | Senegal | ||
| 2 | PS Kedougou-Dalaba | Kedougou | Senegal | ||
| 3 | PS Mbour-Toucouleur | Mbour | Senegal | ||
| 4 | PS Pont-Tambacounda | Tambacounda | Senegal |
Sponsors and Collaborators
- Foundation for Innovative New Diagnostics, Switzerland
- Institut Pasteur de Dakar
- Ministry of Health, Senegal
Investigators
- Principal Investigator: Fabien Taieb, MD, Institut Pasteur de Dakar
- Principal Investigator: Aliou Barry, MD, Institut Pasteur de Dakar
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FE007