Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal

NCT05050825 | Unknown

• 1 other identifier: FE007
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

clinical algorithms; mHealth; Integrated management for childhood illness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Antibiotic prescription rate during 7 days of follow-up in the intervention arm compared to the control arm

  4 months

• Diagnostic performance of the dengue rapid diagnostic test (RDT)

  4 months

• Identification of risk factors associated with viral and bacterial infections

  4 months

Other Outcomes (1)

• Usability of the CDSA strategy

  4 months

Study Arms (2)

CDSA strategy

EXPERIMENTAL

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

Routine practice

NO INTERVENTION

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

Interventions

Patient clinical management based on the CDSA strategy 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.

CDSA strategy

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infants less than 6 months of age
• Age ≥ 15 years
• Clinical status requiring immediate transfer to an appropriate care facility/ severe illness

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Institut Pasteur de Dakar: collaborator
• Ministry of Health, Senegal: collaborator

Study Sites (4)

PS Ndiaye-Fatick

Fatick, Senegal

RECRUITING

PS Kedougou-Dalaba

Kédougou, Senegal

RECRUITING

PS Mbour-Toucouleur

Mbour, Senegal

RECRUITING

PS Pont-Tambacounda

Tambacounda, Senegal

RECRUITING

MeSH Terms

Conditions

Malaria; Dengue; Diarrhea; Pneumonia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fabien Taieb, MD

  Institut Pasteur de Dakar

  PRINCIPAL INVESTIGATOR

• Aliou Barry, MD

  Institut Pasteur de Dakar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karell G Pellé, PhD

CONTACT

+41798804538; Karell.Pelle@finddx.org

Aliou Barry, MD

CONTACT

+221772850035; aliou.barry@pasteur.sn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control (routine practice) vs Intervention ("CDSA" strategy)

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: May 3, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 15, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-09

Locations

SE (4)