Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal

Not Applicable

• Conditions: Malaria; Dengue; Pneumonia; Diarrhea; Acute Febrile Illness; Influenza -Like Illness
• Interventions: Other: Patient clinical management based on the CDSA strategy

• Registration Number: NCT05050825
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-03
• Status Verified: 2021-09
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 470

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDSA strategy	Patient clinical management based on the CDSA strategy	Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers trained on the CDSA strategy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (4)

PS Ndiaye-Fatick; 🇸🇳 Fatick, Senegal

PS Kedougou-Dalaba; 🇸🇳 Kedougou, Senegal

PS Mbour-Toucouleur; 🇸🇳 Mbour, Senegal

PS Pont-Tambacounda; 🇸🇳 Tambacounda, Senegal