Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal

Foundation for Innovative New Diagnostics (FIND)

Status: Unknown

Conditions: Dengue; Influenza -Like Illness; Diarrhea; Malaria; Acute Febrile Illness; Pneumonia

Treatments: Other: Patient clinical management based on the CDSA strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05050825

FE007

Details and patient eligibility

About

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.

Enrollment: 470 estimated patients

Sex: All

Ages: 6 months to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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470 participants in 2 patient groups

CDSA strategy

Experimental group

Description:

Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers trained on the CDSA strategy

Treatment:

Other: Patient clinical management based on the CDSA strategy

Routine practice

No Intervention group

Description:

Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers according to routine practice at the health facility