Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050825
• Other study ID #: FE007
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: September 2021
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: Karell G Pellé, PhD
• Phone: +41798804538
• Email: Karell.Pelle[@]finddx.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: December 15, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Senegal	PS Ndiaye-Fatick	Fatick
Senegal	PS Kedougou-Dalaba	Kedougou
Senegal	PS Mbour-Toucouleur	Mbour
Senegal	PS Pont-Tambacounda	Tambacounda

Sponsors (3)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Institut Pasteur de Dakar, Ministry of Health, Senegal

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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