Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal

Study Overview
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Brief Summary
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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.

Official Title
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Validation of an Assisted Medical Care Strategy Composed of a Clinical Decision Support System and RDTs to Reduce Antibiotic Prescription in Non-severe Acute Disease in Children 15 Years Old and Younger in Senegal

Conditions
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Malaria, Dengue, Influenza -Like Illness, Diarrhea, Pneumonia, Acute Febrile Illness

Intervention / Treatment
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* Other: Patient clinical management based on the CDSA strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ongoing fever or diarrhea 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 ongoing diarrhea will be defined as at least 3 abnormal stools during the last 24hrs First consultation for the current illness Feasibility of contact between the patient (or his/her designated relative) and the study team at day 3 and day 7 Written informed consent by the caretaker/legally acceptable representative Exclusion Criteria: Infants less than 6 months of age Age ≥ 15 years Clinical status requiring immediate transfer to an appropriate care facility/ severe illness

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control (routine practice) vs Intervention (CDSA strategy)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDSA strategy<br>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<br>* 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.<br>|
| No Intervention: Routine practice<br>Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers according to routine practice at the health facility | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of the CDSA strategy when compared to routine practice in terms of clinical status assessed at Day 7 | 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. | 4 months | 
| Superiority of the CDSA strategy when compared to routine practice in terms of antibiotic prescription at Day 0 | 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic prescription rate during 7 days of follow-up in the intervention arm compared to the control arm | This measure will further assess rational antibiotic prescribing using the CDSA strategy compared to routine practice. | 4 months | 
| Diagnostic performance of the dengue rapid diagnostic test (RDT) | The performance of the dengue RDT used in health facilities will be assessed against reference standards. | 4 months | 
| Identification of risk factors associated with viral and bacterial infections | 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. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical algorithms, mHealth, Integrated management for childhood illness