Acute Febrile Illness, Dengue, Diarrhea, Influenza -Like Illness, Malaria, Pneumonia
Conditions
Keywords
clinical algorithms, mHealth, Integrated management for childhood illness
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.
Interventions
OTHERPatient 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.
Sponsors
Foundation for Innovative New Diagnostics, Switzerland
Institut Pasteur de Dakar
Ministry of Health, Senegal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Control (routine practice) vs Intervention ("CDSA" strategy)
Eligibility
Sex/Gender
ALL
Age
6 Months to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Senegal
Contacts
PRINCIPAL_INVESTIGATORFabien Taieb, MD
Institut Pasteur de Dakar
PRINCIPAL_INVESTIGATORAliou Barry, MD
Institut Pasteur de Dakar
Outcome results
None listed