Respiratory Tract DiseasesICARENCT07632651
Impact of C-reactive Protein Micromethod Testing in Primary Care on Antibiotics Delivery in Patients With Upper or Lower Respiratory Tract Infections
A study testing Quick test in people with Respiratory Tract Diseases, run by MSPU des 3 Provinces at 1 site in France.
Trial summary
The project is a pragmatic approach to primary care. The main objective is to evaluate the impact of making a CRP measurement device available in primary care general practices on antibiotic prescribing for upper respiratory tract (URT) or lower respiratory tract (LRT) infections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Diseases
- What is being tested?
- Quick test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2023to 14 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have received information and given written consent
- Patients of any age consulting a general practice with one or more of the following symptoms: fever, cough, arthralgias, myalgias, rhinorrhea;
- Symptomatology evolving for more than 24 hours;
- Symptoms associated with an upper respiratory tract infection such as otitis, angina, laryngitis, rhinopharyngitis, sinusitis; and/or a lower respiratory tract infection such as acute bronchitis, pneumonia, exacerbation of COPD (chronic obstructive pulmonary disease).
Who cannot join
- These criteria correspond to factors making interpretation of the CRP value difficult:
- Antibiotics taken in the 15 days prior to inclusion
- Presence of one of the following signs of severity requiring immediate hospitalization:
- Impairment of higher functions (altered consciousness) Sign of severity (Pas\<90mmHg; HR\>120/min; FR\>30 cycles/min) Temperature \<35 or \>40°c Inhalation pneumonitis
- Sepsis: organ dysfunction, FR\>22cycles/min, PAS≤100 mmHg and Galsgow score ≤ 13(34)
- Immediate hospitalization
Show all 16Show fewer
- Pregnancy
- Burns
- Heat stroke
- Presenting with an associated serious pathology:
- Associated neoplastic disease in progress
- Severe liver failure
- Ischemic or thromboembolic pathology
- Traumatic pathology
- Inflammatory rheumatism
- Autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of C-reactive Protein Micromethod Testing in Primary Care on Antibiotics Delivery in Patients With Upper or Lower Respiratory Tract Infections: a Randomized Pragmatic Intervention Trial
The project is a pragmatic approach to primary care. The main objective is to evaluate the impact of making a CRP measurement device available in primary care general practices on antibiotic prescribing for upper respiratory tract (URT) or lower respiratory tract (LRT) infections.
- Conditions
- Respiratory Tract Diseases
- Being tested
- Quick test
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quick testDiagnostic test
The 70 GPs in the intervention arm will be able to measure CRP levels by using the Quick read GO in patients with upper or lower respiratory tract infections
| Study group | Role | What they receive |
|---|---|---|
| TROD | Experimental | The study involves equipping 70 physicians assigned to the experimental group with a TROD (a bedside rapid test) Receives: Diagnostic Test: Quick test |
| Control | No intervention | The intervention group consists of 70 physicians equipped with a TROD (a bedside rapid test), while the control group comprises 70 physicians without access to a TROD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic dispensing rate
This calculated index is defined by the French health insurance scheme as the "number of antibiotic treatments per 100 patients aged 16 to 65 / attending physician". It is expressed as a percentage.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
antibiotics prescriptions in other unit of measure
defined daily doses delivered per 1000 patients in both groups (doctors with or whitout TROD)
Measured: through study completion, an average of 1 year
Factors influencing the modulation of antibiotic dispensing
factors may be influence the modulation of antibiotic dispensing:
- age of physician in year (age group or average age)
- physician gender, qualitative data (number of male gender or number of femal gender)
- practitioner training supervisor or not, qualitative date "yes" or "not"
- physician geographical location, qualitative data (rural or urban)
- type of exercice, qualitative data (medical center or single exercice)
- seasonal effect, comparison of various parameters according to the winter or summer period
- volume of patients followed by years (number of patients treated by the general practitioner by year)
- type of patients followed : number of patients with or without long-term illness followed by the GP, age (years) of patients followed by the GP, gender of patients (in number or percentage) followed by the GP
Measured: baseline and one year
Evolution of antibiotic dispensing in the daily delivered dose in both GP's groups (doctors with and without TROD)
temporal variability in the daily delivered dose of antibiotics prescriptions in both GP's groups (doctors with and without TROD)
Measured: baseline and 3 months, baseline and 6 months, baseline and 1 year, between winter and summer period
Complementary radiological and biological examinations
- number of chest X-rays prescribed in both groups (doctors with and without TROD)
- number of biological examinations (blood counts, CRP, ferritinemia, firinogen, urine cytobacteriological examination) prescribed in both groups (doctors with and without TROD);
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start14 Mar 2023
- Primary completion14 Mar 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- MSPU des 3 Provinces
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632651
- Sponsor's protocol ID
- 2022-A00747-36
- Acronym
- ICARE
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2025
- Last updated
- 8 Jun 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of C-reactive Protein Micromethod Testing in Primary Care on Antibiotics Delivery in Patients With Upper or Lower Respiratory Tract Infections: a Randomized Pragmatic Intervention Trial
- ClinicalTrials.gov ID
- NCT07632651
- Acronym / sponsor ID
- ICARE / 2022-A00747-36
- Conditions
- Respiratory Tract Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- MSPU des 3 ProvincesUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 8 Jun 2026 (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.
The project is a pragmatic approach to primary care. The main objective is to evaluate the impact of making a CRP measurement device available in primary care general practices on antibiotic prescribing for upper respiratory tract (URT) or lower respiratory tract (LRT) infections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TROD | Experimental | Diagnostic Test: Quick testThe study involves equipping 70 physicians assigned to the experimental group with a TROD (a bedside rapid test) |
| Control | No intervention | –The intervention group consists of 70 physicians equipped with a TROD (a bedside rapid test), while the control group comprises 70 physicians without access to a TROD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have received information and given written consent
- Patients of any age consulting a general practice with one or more of the following symptoms: fever, cough, arthralgias, myalgias, rhinorrhea;
- Symptomatology evolving for more than 24 hours;
- Symptoms associated with an upper respiratory tract infection such as otitis, angina, laryngitis, rhinopharyngitis, sinusitis; and/or a lower respiratory tract infection such as acute bronchitis, pneumonia, exacerbation of COPD (chronic obstructive pulmonary disease).
Key exclusion criteria (16 listed)
- Antibiotics taken in the 15 days prior to inclusion
- Presence of one of the following signs of severity requiring immediate hospitalization:
- Impairment of higher functions (altered consciousness) Sign of severity (Pas\<90mmHg; HR\>120/min; FR\>30 cycles/min) Temperature \<35 or \>40°c Inhalation pneumonitis
- Sepsis: organ dysfunction, FR\>22cycles/min, PAS≤100 mmHg and Galsgow score ≤ 13(34)
- Immediate hospitalization
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 |
|---|---|---|
| Quick testThe 70 GPs in the intervention arm will be able to measure CRP levels by using the Quick read GO in patients with upper or lower respiratory tract infections | Diagnostic test | TROD |
Primary outcome
Antibiotic dispensing rate
Time frame: through study completion, an average of 1 year
This calculated index is defined by the French health insurance scheme as the "number of antibiotic treatments per 100 patients aged 16 to 65 / attending physician". It is expressed as a percentage.
4 secondary outcomes
antibiotics prescriptions in other unit of measure
Time frame: through study completion, an average of 1 year
Factors influencing the modulation of antibiotic dispensing
Time frame: baseline and one year
Evolution of antibiotic dispensing in the daily delivered dose in both GP's groups (doctors with and without TROD)
Time frame: baseline and 3 months, baseline and 6 months, baseline and 1 year, between winter and summer period
Complementary radiological and biological examinations
Time frame: one year
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 8 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quick test in people with Respiratory Tract Diseases, run by MSPU des 3 Provinces at 1 site in France.
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 4 inclusion and 16 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Antibiotic dispensing rate (time frame: through study completion, an average of 1 year). 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 8 Jun 2026.