An interventional study of Patient clinical management based on the CDSA strategy in Malaria, Dengue and Influenza -Like Illness, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 4 sites in Senegal. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Not applicable, Interventional, and Diagnostic
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 470 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers according to routine practice at the health facility
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.
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.
Time frame: 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.
Time frame: 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
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.
Time frame: 4 months
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland