MalariaNCT05050825
Validation of a CDSA Strategy to Reduce Antibiotic Prescription in Senegal
A study testing Patient clinical management based on the CDSA strategy in people with Malaria and Dengue, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in Senegal.
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… Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Malaria, Dengue, Influenza -Like Illness
- What is being tested?
- Patient clinical management based on the CDSA strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 4 sitesSenegal
- Study dates
- 3 May 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Infants less than 6 months of age
- Age ≥ 15 years
- Clinical status requiring immediate transfer to an appropriate care facility/ severe illness
Trial locations and contacts
4 sites in 1 country.
Senegal4 sites
PS Ndiaye-Fatick
Fatick
PS Kedougou-Dalaba
Kedougou
PS Mbour-Toucouleur
Mbour
PS Pont-Tambacounda
Tambacounda
About this study
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
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
- Being tested
- Patient clinical management based on the CDSA strategy
- Keywords
- clinical algorithms, mHealth, Integrated management for childhood illness
- Medical subject headings
- Malaria, Dengue, Diarrhea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient clinical management based on the CDSA strategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CDSA strategy | Experimental | Children and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers trained on the CDSA strategy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Secondary outcomes (3)
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start3 May 2021
- Primary completion30 Nov 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control (routine practice) vs Intervention ("CDSA" strategy)
- Masking
- None (open label)
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Dakar, Ministry of Health, Senegal
- Responsible party
- Sponsor
- Investigators
- Fabien Taieb, MD, Principal investigator, Institut Pasteur de DakarAliou Barry, MD, Principal investigator, Institut Pasteur de Dakar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050825
- Sponsor's protocol ID
- FE007
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2021
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05050825
- Acronym / sponsor ID
- FE007
- Conditions
- Malaria, Dengue, Influenza -Like Illness, Diarrhea, Pneumonia, Acute Febrile Illness
- Keywords
- clinical algorithms, mHealth, Integrated management for childhood illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Institut Pasteur de Dakar, Ministry of Health, Senegal
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control (routine practice) vs Intervention ("CDSA" strategy)
| Arm | Type | Receives |
|---|---|---|
| CDSA strategy | Experimental | Other: Patient clinical management based on the CDSA strategyChildren and adolescents presenting with non-severe acute febrile illness or diarrhea managed by healthcare workers trained 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 |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Infants less than 6 months of age
- Age ≥ 15 years
- Clinical status requiring immediate transfer to an appropriate care facility/ severe illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient clinical management based on the CDSA strategyThe 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. | Other | CDSA strategy |
Primary outcome
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.
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.
3 secondary outcomes
Antibiotic prescription rate during 7 days of follow-up in the intervention arm compared to the control arm
Time frame: 4 months
Diagnostic performance of the dengue rapid diagnostic test (RDT)
Time frame: 4 months
Identification of risk factors associated with viral and bacterial infections
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien Taieb, MD principal investigator
Institut Pasteur de Dakar
Aliou Barry, MD principal investigator
Institut Pasteur de Dakar
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient clinical management based on the CDSA strategy in people with Malaria and Dengue, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of the CDSA strategy when compared to routine practice in terms of clinical status assessed at Day 7 (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.