Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Diarrhea; Malaria; Dengue; Acute Febrile Illness; Influenza -Like Illness
• Intervention / Treatment: Other: Patient clinical management based on the CDSA strategy

• Study Type: Interventional
• Enrollment (Anticipated): 470
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karell G Pellé, PhD; Phone Number: +41798804538; Email: Karell.Pelle@finddx.org
• Study Contact Backup: Name: Aliou Barry, MD; Phone Number: +221772850035; Email: aliou.barry@pasteur.sn

Study Locations

• Senegal
  • Fatick, Senegal
    • Recruiting
    • PS Ndiaye-Fatick
    • Contact: Aliou Barry, MD
  • Kedougou, Senegal
    • Recruiting
    • PS Kedougou-Dalaba
    • Contact: Aliou Barry, MD
  • Mbour, Senegal
    • Recruiting
    • PS Mbour-Toucouleur
    • Contact: Aliou Barry, MD
  • Tambacounda, Senegal
    • Recruiting
    • PS Pont-Tambacounda
    • Contact: Aliou Barry, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CDSA strategy; 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; 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.
NO_INTERVENTION: Routine practice; Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers according to routine practice at the health facility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Collaborators: Ministry of Health, Senegal; Institut Pasteur de Dakar
• Investigators: Principal Investigator: Fabien Taieb, MD, Institut Pasteur de Dakar; Principal Investigator: Aliou Barry, MD, Institut Pasteur de Dakar

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2021
• Primary Completion (ANTICIPATED): November 30, 2021
• Study Completion (ANTICIPATED): December 15, 2021

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (ACTUAL): September 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: mHealth; clinical algorithms; Integrated management for childhood illness
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: FE007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No