Skip to main content
OpenTrials
Completed

NCT Number: NCT05050825

Validation of a CDSA Strategy to Reduce Antibiotic Prescription 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malaria Acute Febrile Illness Arbovirus Infections Dengue Diarrhea Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Influenza -Like Illness Lung Diseases Mosquito-Borne Diseases Parasitic Diseases Pathological Conditions, Signs and Symptoms Pneumonia Protozoan Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Vector Borne Diseases Virus Diseases

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PS Ndiaye-Fatick, Fatick, Senegal

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Non-inferiority of the CDSA strategy when compared to routine practice in terms of clinical status assessed at Day 7

    Time frame: 4 months

    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.

  2. Superiority of the CDSA strategy when compared to routine practice in terms of antibiotic prescription at Day 0

    Time frame: 4 months

    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 outcomes

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

    Time frame: 4 months

    This measure will further assess rational antibiotic prescribing using the CDSA strategy compared to routine practice.

  2. Diagnostic performance of the dengue rapid diagnostic test (RDT)

    Time frame: 4 months

    The performance of the dengue RDT used in health facilities will be assessed against reference standards.

  3. Identification of risk factors associated with viral and bacterial infections

    Time frame: 4 months

    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.

Other outcomes

  1. Usability of the CDSA strategy

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

  • Institut Pasteur de Dakar
  • Ministry of Health, Senegal

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2021
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.