Clinical trial NCT05050825: Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malaria
Dengue
Influenza -Like Illness
Diarrhea
Pneumonia
Acute Febrile Illness
Keywords: clinical algorithms
mHealth
Integrated management for childhood illness
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Institut Pasteur de Dakar
name: Ministry of Health, Senegal
First posted: 2021-09-21
Enrollment: 470
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control (routine practice) vs Intervention ("CDSA" strategy)
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Non-inferiority of the CDSA strategy when compared to routine practice in terms of clinical status assessed at Day 7
timeFrame: 4 months
measure: Superiority of the CDSA strategy when compared to routine practice in terms of antibiotic prescription at Day 0
timeFrame: 4 months
Secondary outcomes:
measure: Antibiotic prescription rate during 7 days of follow-up in the intervention arm compared to the control arm
timeFrame: 4 months
measure: Diagnostic performance of the dengue rapid diagnostic test (RDT)
timeFrame: 4 months
measure: Identification of risk factors associated with viral and bacterial infections
timeFrame: 4 months
Other outcomes:
measure: Usability of the CDSA strategy
timeFrame: 4 months
Locations:
city: Fatick
country: Senegal
facility: PS Ndiaye-Fatick
city: Kedougou
country: Senegal
facility: PS Kedougou-Dalaba
city: Mbour
country: Senegal
facility: PS Mbour-Toucouleur
city: Tambacounda
country: Senegal
facility: PS Pont-Tambacounda
Study officials:
affiliation: Institut Pasteur de Dakar
name: Fabien Taieb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Pasteur de Dakar
name: Aliou Barry, MD
role: PRINCIPAL_INVESTIGATOR
References: