Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal

NCT ID: NCT05050825

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2021-12-15

Brief Summary

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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

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Conditions

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Malaria Dengue Influenza -Like Illness Diarrhea Pneumonia Acute Febrile Illness

Keywords

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clinical algorithms mHealth Integrated management for childhood illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control (routine practice) vs Intervention ("CDSA" strategy)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CDSA strategy

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

Group Type EXPERIMENTAL

Patient clinical management based on the CDSA strategy

Intervention Type OTHER

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Pasteur de Dakar

OTHER

Sponsor Role collaborator

Ministry of Health, Senegal

OTHER_GOV

Sponsor Role collaborator

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabien Taieb, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Dakar

Aliou Barry, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Dakar

Locations

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PS Ndiaye-Fatick

Fatick, , Senegal

Site Status RECRUITING

PS Kedougou-Dalaba

Kédougou, , Senegal

Site Status RECRUITING

PS Mbour-Toucouleur

Mbour, , Senegal

Site Status RECRUITING

PS Pont-Tambacounda

Tambacounda, , Senegal

Site Status RECRUITING

Countries

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Senegal

Central Contacts

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Karell G Pellé, PhD

Role: CONTACT

Phone: +41798804538

Email: [email protected]

Aliou Barry, MD

Role: CONTACT

Phone: +221772850035

Email: [email protected]

Facility Contacts

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Aliou Barry, MD

Role: primary

Aliou Barry, MD

Role: primary

Aliou Barry, MD

Role: primary

Aliou Barry, MD

Role: primary

Other Identifiers

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FE007

Identifier Type: -

Identifier Source: org_study_id