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| Name | Class |
|---|---|
| Institut Pasteur de Dakar | OTHER |
| Ministry of Health, Senegal | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDSA strategy | Experimental | Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers trained on the CDSA strategy |
|
| Routine practice | No Intervention | Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers according to routine practice at the health facility |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient clinical management based on the CDSA strategy | Other | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the CDSA strategy | 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. | 4 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karell G Pellé, PhD | Contact | +41798804538 | Karell.Pelle@finddx.org | |
| Aliou Barry, MD | Contact | +221772850035 | aliou.barry@pasteur.sn |
| Name | Affiliation | Role |
|---|---|---|
| Fabien Taieb, MD | Institut Pasteur de Dakar | Principal Investigator |
| Aliou Barry, MD | Institut Pasteur de Dakar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PS Ndiaye-Fatick | Recruiting | Fatick | Senegal |
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Control (routine practice) vs Intervention ("CDSA" strategy)
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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 |
| PS Kedougou-Dalaba | Recruiting | Kedougou | Senegal |
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| PS Mbour-Toucouleur | Recruiting | Mbour | Senegal |
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| PS Pont-Tambacounda | Recruiting | Tambacounda | Senegal |
|
| ID | Term |
|---|---|
| D008288 | Malaria |
| D003715 | Dengue |
| D003967 | Diarrhea |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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