Back to resultsValidation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal
Primary Purpose
Malaria, Dengue, Influenza -Like Illness
Status
Unknown status
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
Patient clinical management based on the CDSA strategy
Sponsored by
About this trial
This is an interventional diagnostic trial for Malaria focused on measuring clinical algorithms, mHealth, Integrated management for childhood illness
Eligibility Criteria
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
Sites / Locations
- PS Ndiaye-FatickRecruiting
- PS Kedougou-DalabaRecruiting
- PS Mbour-ToucouleurRecruiting
- PS Pont-TambacoundaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CDSA strategy
Routine practice
Arm Description
Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers trained on the CDSA strategy
Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers according to routine practice at the health facility
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05050825
First Posted
September 10, 2021
Last Updated
October 26, 2021
Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Institut Pasteur de Dakar, Ministry of Health, Senegal
1. Study Identification
Unique Protocol Identification Number
NCT05050825
Brief Title
Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Institut Pasteur de Dakar, Ministry of Health, Senegal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Dengue, Influenza -Like Illness, Diarrhea, Pneumonia, Acute Febrile Illness
Keywords
clinical algorithms, mHealth, Integrated management for childhood illness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control (routine practice) vs Intervention ("CDSA" strategy)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CDSA strategy
Arm Type
Experimental
Arm Description
Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers trained on the CDSA strategy
Arm Title
Routine practice
Arm Type
No Intervention
Arm Description
Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers according to routine practice at the health facility
Intervention Type
Other
Intervention Name(s)
Patient clinical management based on the CDSA strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Non-inferiority of the CDSA strategy when compared to routine practice in terms of clinical status assessed at Day 7
Description
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.
Time Frame
4 months
Title
Superiority of the CDSA strategy when compared to routine practice in terms of antibiotic prescription at Day 0
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Antibiotic prescription rate during 7 days of follow-up in the intervention arm compared to the control arm
Description
This measure will further assess rational antibiotic prescribing using the CDSA strategy compared to routine practice.
Time Frame
4 months
Title
Diagnostic performance of the dengue rapid diagnostic test (RDT)
Description
The performance of the dengue RDT used in health facilities will be assessed against reference standards.
Time Frame
4 months
Title
Identification of risk factors associated with viral and bacterial infections
Description
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.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Usability of the CDSA strategy
Description
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karell G Pellé, PhD
Phone
+41798804538
Email
Karell.Pelle@finddx.org
First Name & Middle Initial & Last Name or Official Title & Degree
Aliou Barry, MD
Phone
+221772850035
Email
aliou.barry@pasteur.sn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien Taieb, MD
Organizational Affiliation
Institut Pasteur de Dakar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aliou Barry, MD
Organizational Affiliation
Institut Pasteur de Dakar
Official's Role
Principal Investigator
Facility Information:
Facility Name
PS Ndiaye-Fatick
City
Fatick
Country
Senegal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliou Barry, MD
Facility Name
PS Kedougou-Dalaba
City
Kedougou
Country
Senegal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliou Barry, MD
Facility Name
PS Mbour-Toucouleur
City
Mbour
Country
Senegal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliou Barry, MD
Facility Name
PS Pont-Tambacounda
City
Tambacounda
Country
Senegal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliou Barry, MD
12. IPD Sharing Statement
Learn more about this trial
Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal
We'll reach out to this number within 24 hrs