Respiratory InfectionVIPNCT03540706
Impact of the Use of CRP on the Prescription of Antibiotics in General Practitioners
A study testing Care with C-reactive protein assay in micro method in people with Respiratory Infection and Respiratory Infections in Children, run by Centre Hospitalier Intercommunal Creteil at 14 sites in France.
Trial summary
Respiratory infections, including episodes of coughing with fever, are the main cause of outpatient antibiotic prescription, while a minority of them are linked to bacterial infections requiring antibiotic. These prescriptions are often performed by general practitioners. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Respiratory Infection, Respiratory Infections in Children
- What is being tested?
- Care with C-reactive protein assay in micro method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 14 sitesFrance
- Study dates
- 1 May 2018to 13 Mar 2023
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 3 years
- Clinical suspicion of respiratory infection defined by the presence of at least one respiratory sign among, cough, dyspnea, chest pain and auscultatory abnormality and at least one general sign among fever, sweat, headache, myalgia, impairment of general condition
- Affiliated to a social health insurance
- Signed consent
Who cannot join
- Duration of symptoms < 24 hours
- Hospitalization or emergency assessment decision decided from the outset
- Signs of severity before the realization of POCT-CRP
- Patient previously included in the study for the same episode
- Antibiotic therapy within 7 days
- Chronic cough (more than 3 weeks)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
22 rue de Silly
Boulogne, 92100
18 rue Sainte Bathilde
Chelles, 77500
25 avenue des frères Lumière
Cormeilles-en-Parisis, 95240
8 Rue Saint-Exupéry
Meudon-la-Forêt, 92360
258 Bis Rue de Paris
Montreuil, 93100
61bis Boulevard de Charonne
Paris, 75011
25 Rue de Fécamp
Paris, 75012
237 Rue de la Croix Nivert,
Paris, 75015
1 Rue Colette Magny
Paris, 75019
391 Rue des Pyrénées
Paris, 75020
50 Rue de la Justice
Paris, 75020
72 Boulevard Davout
Paris, 75020
20 avenue Gorges Sand
Stains, 93240
19 Rue du Midi
Vincennes, 94300
About this study
Official title: Impact of the Use of C-reactive Protein in a Micro-method on the Prescription of Antibiotics in General Practitioners Consulting in the Office
Respiratory infections, including episodes of coughing with fever, are the main cause of outpatient antibiotic prescription, while a minority of them are linked to bacterial infections requiring antibiotic. These prescriptions are often performed by general practitioners. These unnecessary antibiotic contribute to increased bacterial resistance, side effects and unnecessary costs. Campaigns for the correct prescription of antibiotics have had a real but partial or transient success.
C-reactive protein micro-method (POCT-CRP) could help to differentiate between viral and bacterial infections and thus contribute to the proper use of antibiotics. The decrease in prescription of antibiotics is likely to have an even stronger positive impact in countries like France, where prescription is high.
The objective of this study is to evaluate the use of POCT-CRP in the general practitioner's office in case of suspected respiratory infection.
- Being tested
- Care with C-reactive protein assay in micro method
- Keywords
- Respiratory Infections, C-reactive protein, antibiotic prescription
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care with C-reactive protein assay in micro methodDiagnostic test
Care with C-reactive protein assay in micro method
| Study group | Role | What they receive |
|---|---|---|
| Care with C-reactive protein assay in micro method | Experimental | During a visit to the general practitioner for a clinical suspicion of respiratory infection, the doctor will practice a C-reactive protein assay in micro method. He will prescribe antibiotics according to the result of the dosage Receives: Diagnostic Test: Care with C-reactive protein assay in micro method |
| Care without C-reactive protein assay in micro method | No intervention | Simple management of a patient coming for a suspicion of respiratory infection without dosage of the C-reactive protein in micro method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of antibiotic therapy prescribed
with and without POCT-CRP
Measured: 10 days
Secondary outcomes (11)
Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old
with and without POCT-CRP
Measured: 10 days
Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old
with and without POCT-CRP
Measured: 10 days
Frequency of antibiotic therapy prescribed in patients older than 65 years old
with and without POCT-CRP
Measured: 10 days
Type of antibiotic prescribed
Measured: 10 days
Frequency of complementary exam
with and without POCT-CRP
Measured: 10 days
type of complementary exam
with and without POCT-CRP
Measured: 10 days
Proportion of number of patients referred to emergency
with and without POCT-CRP
Measured: 10 days
Proportion of number of patients with delayed antibiotic therapy
with and without POCT-CRP
Measured: 10 days
number of prescription following the recommended algorythms
Adequacy between the proposed decision algorithm according to the C-reactive protein assay and the antibiotic prescription
Measured: 10 days
Concordance between the prescription proposed by the decision algorithm as a function of the micro-CRP and the prescription realized: kappa coefficient
The assessment of the utility of the POCT procedure
Measured: 10 days
COVID-19 positive patients
Number of COVID-19 positive patients by diagnostic method (From October 2020)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 May 2018
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Respiratory InfectionStudies 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
- Masking
- None (open label)
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540706
- Sponsor's protocol ID
- VIP
- Other IDs
- 2018-A00242-53, AOR17072
- Acronym
- VIP
- Status last verified
- Aug 2023
- First submitted
- 17 May 2018
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulliford MC, Moore MV, Little P, Hay AD, Fox R, Prevost AT, Juszczyk D, Charlton J, Ashworth M. Safety of reduced antibiotic prescribing for self limiting respiratory tract infections in primary care: cohort study using electronic health records. BMJ. 2016 Jul 4;354:i3410. doi: 10.1136/bmj.i3410.
PubMed 27378578Llor C, Moragas A, Cots JM, Lopez-Valcarcel BG; Happy Audit Study Group. Estimated saving of antibiotics in pharyngitis and lower respiratory tract infections if general practitioners used rapid tests and followed guidelines. Aten Primaria. 2017 Jun-Jul;49(6):319-325. doi: 10.1016/j.aprim.2016.07.002. Epub 2016 Nov 22.
PubMed 27884552van Vugt SF, Verheij TJ, de Jong PA, Butler CC, Hood K, Coenen S, Goossens H, Little P, Broekhuizen BD; GRACE Project Group. Diagnosing pneumonia in patients with acute cough: clinical judgment compared to chest radiography. Eur Respir J. 2013 Oct;42(4):1076-82. doi: 10.1183/09031936.00111012. Epub 2013 Jan 24.
PubMed 23349450Huang Y, Chen R, Wu T, Wei X, Guo A. Association between point-of-care CRP testing and antibiotic prescribing in respiratory tract infections: a systematic review and meta-analysis of primary care studies. Br J Gen Pract. 2013 Nov;63(616):e787-94. doi: 10.3399/bjgp13X674477.
PubMed 24267862Kapasi AJ, Dittrich S, Gonzalez IJ, Rodwell TC. Host Biomarkers for Distinguishing Bacterial from Non-Bacterial Causes of Acute Febrile Illness: A Comprehensive Review. PLoS One. 2016 Aug 3;11(8):e0160278. doi: 10.1371/journal.pone.0160278. eCollection 2016.
PubMed 27486746Ivaska L, Niemela J, Leino P, Mertsola J, Peltola V. Accuracy and feasibility of point-of-care white blood cell count and C-reactive protein measurements at the pediatric emergency department. PLoS One. 2015 Jun 2;10(6):e0129920. doi: 10.1371/journal.pone.0129920. eCollection 2015.
PubMed 26034987Esposito S, Tremolati E, Begliatti E, Bosis S, Gualtieri L, Principi N. Evaluation of a rapid bedside test for the quantitative determination of C-reactive protein. Clin Chem Lab Med. 2005;43(4):438-40. doi: 10.1515/CCLM.2005.077.
PubMed 15899661Cohen R, Lecuyer A, Wollner C, Deberdt P, Thollot F, Henriquet V, de La Rocque F. [Evaluation of impact of CRP rapid test in management of febrile children in ambulatory pediatric practice]. Arch Pediatr. 2008 Jun;15(6):1126-32. doi: 10.1016/j.arcped.2008.03.007. Epub 2008 May 16. French.
PubMed 18486458Cohen R, Romain O, Levy C, Perreaux F, Decobert M, Hau I, Lecuyer A, Lesprit E, Maman L, Roullaud S, Cheron G, Bekri A, d'Athis P, Henriquet V, de La Rocque F. [Impact of CRP rapid test in management of febrile children in paediatric emergency units of Ile-de-France]. Arch Pediatr. 2006 Dec;13(12):1566-71. doi: 10.1016/j.arcped.2006.09.003. Epub 2006 Oct 27. French.
PubMed 17070024Do NT, Ta NT, Tran NT, Than HM, Vu BT, Hoang LB, van Doorn HR, Vu DT, Cals JW, Chandna A, Lubell Y, Nadjm B, Thwaites G, Wolbers M, Nguyen KV, Wertheim HF. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial. Lancet Glob Health. 2016 Sep;4(9):e633-41. doi: 10.1016/S2214-109X(16)30142-5. Epub 2016 Aug 3.
PubMed 27495137Minnaard MC, van de Pol AC, Hopstaken RM, van Delft S, Broekhuizen BD, Verheij TJ, de Wit NJ. C-reactive protein point-of-care testing and associated antibiotic prescribing. Fam Pract. 2016 Aug;33(4):408-13. doi: 10.1093/fampra/cmw039. Epub 2016 May 26.
PubMed 27230745Verlee L, Verheij TJ, Hopstaken RM, Prins JM, Salome PL, Bindels PJ. [Summary of NHG practice guideline 'Acute cough']. Ned Tijdschr Geneeskd. 2012;156(0):A4188. Dutch.
PubMed 22917039van Vugt SF, Broekhuizen BD, Lammens C, Zuithoff NP, de Jong PA, Coenen S, Ieven M, Butler CC, Goossens H, Little P, Verheij TJ; GRACE consortium. Use of serum C reactive protein and procalcitonin concentrations in addition to symptoms and signs to predict pneumonia in patients presenting to primary care with acute cough: diagnostic study. BMJ. 2013 Apr 30;346:f2450. doi: 10.1136/bmj.f2450.
PubMed 23633005Cals JW, Hopstaken RM, Butler CC, Hood K, Severens JL, Dinant GJ. Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T): study protocol of a cluster randomised controlled trial. BMC Fam Pract. 2007 Mar 29;8:15. doi: 10.1186/1471-2296-8-15.
PubMed 17394651Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013 Oct 5;382(9899):1175-82. doi: 10.1016/S0140-6736(13)60994-0. Epub 2013 Jul 31.
PubMed 23915885
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of C-reactive Protein in a Micro-method on the Prescription of Antibiotics in General Practitioners Consulting in the Office
- ClinicalTrials.gov ID
- NCT03540706
- Acronym / sponsor ID
- VIP / VIP
- Keywords
- Respiratory Infections, C-reactive protein, antibiotic prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne
- Study start
- 1 May 2018 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 30 May 2018 (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.
Respiratory infections, including episodes of coughing with fever, are the main cause of outpatient antibiotic prescription, while a minority of them are linked to bacterial infections requiring antibiotic. These prescriptions are often performed by general practitioners. These unnecessary antibiotic contribute to increased bacterial resistance, side effects and unnecessary costs. Campaigns for the correct prescription of antibiotics have had a real but partial or transient success.
C-reactive protein micro-method (POCT-CRP) could help to differentiate between viral and bacterial infections and thus contribute to the proper use of antibiotics. The decrease in prescription of antibiotics is likely to have an even stronger positive impact in countries like France, where prescription is high.
The objective of this study is to evaluate the use of POCT-CRP in the general practitioner's office in case of suspected respiratory infection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care with C-reactive protein assay in micro method | Experimental | Diagnostic Test: Care with C-reactive protein assay in micro methodDuring a visit to the general practitioner for a clinical suspicion of respiratory infection, the doctor will practice a C-reactive protein assay in micro method. He will prescribe antibiotics according to the result of the dosage |
| Care without C-reactive protein assay in micro method | No intervention | –Simple management of a patient coming for a suspicion of respiratory infection without dosage of the C-reactive protein in micro method |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 3 years
- Clinical suspicion of respiratory infection defined by the presence of at least one respiratory sign among, cough, dyspnea, chest pain and auscultatory abnormality and at least one general sign among fever, sweat, headache, myalgia, impairment of general condition
- Affiliated to a social health insurance
- Signed consent
Key exclusion criteria (6 listed)
- Duration of symptoms < 24 hours
- Hospitalization or emergency assessment decision decided from the outset
- Signs of severity before the realization of POCT-CRP
- Patient previously included in the study for the same episode
- Antibiotic therapy within 7 days
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 |
|---|---|---|
| Care with C-reactive protein assay in micro methodCare with C-reactive protein assay in micro method | Diagnostic test | Care with C-reactive protein assay in micro method |
Primary outcome
Frequency of antibiotic therapy prescribed
Time frame: 10 days
with and without POCT-CRP
11 secondary outcomes
Frequency of antibiotic therapy prescribed in patients aged from 3 to 17 years old
Time frame: 10 days
Frequency of antibiotic therapy prescribed in patients aged from 18 to 64 years old
Time frame: 10 days
Frequency of antibiotic therapy prescribed in patients older than 65 years old
Time frame: 10 days
Type of antibiotic prescribed
Time frame: 10 days
Frequency of complementary exam
Time frame: 10 days
type of complementary exam
Time frame: 10 days
Proportion of number of patients referred to emergency
Time frame: 10 days
Proportion of number of patients with delayed antibiotic therapy
Time frame: 10 days
number of prescription following the recommended algorythms
Time frame: 10 days
Concordance between the prescription proposed by the decision algorithm as a function of the micro-CRP and the prescription realized: kappa coefficient
Time frame: 10 days
COVID-19 positive patients
Time frame: 1 day
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 7 Aug 2023.
- Background: PubMed 27378578Gulliford MC, Moore MV, Little P, Hay AD, Fox R, Prevost AT, Juszczyk D, Charlton J, Ashworth M. Safety of reduced antibiotic prescribing for self limiting respiratory tract infections in primary care: cohort study using electronic health records. BMJ. 2016 Jul 4;354:i3410. doi: 10.1136/bmj.i3410.
- Background: PubMed 27884552Llor C, Moragas A, Cots JM, Lopez-Valcarcel BG; Happy Audit Study Group. Estimated saving of antibiotics in pharyngitis and lower respiratory tract infections if general practitioners used rapid tests and followed guidelines. Aten Primaria. 2017 Jun-Jul;49(6):319-325. doi: 10.1016/j.aprim.2016.07.002. Epub 2016 Nov 22.
- Background: PubMed 23349450van Vugt SF, Verheij TJ, de Jong PA, Butler CC, Hood K, Coenen S, Goossens H, Little P, Broekhuizen BD; GRACE Project Group. Diagnosing pneumonia in patients with acute cough: clinical judgment compared to chest radiography. Eur Respir J. 2013 Oct;42(4):1076-82. doi: 10.1183/09031936.00111012. Epub 2013 Jan 24.
- Background: PubMed 24267862Huang Y, Chen R, Wu T, Wei X, Guo A. Association between point-of-care CRP testing and antibiotic prescribing in respiratory tract infections: a systematic review and meta-analysis of primary care studies. Br J Gen Pract. 2013 Nov;63(616):e787-94. doi: 10.3399/bjgp13X674477.
- Background: PubMed 27486746Kapasi AJ, Dittrich S, Gonzalez IJ, Rodwell TC. Host Biomarkers for Distinguishing Bacterial from Non-Bacterial Causes of Acute Febrile Illness: A Comprehensive Review. PLoS One. 2016 Aug 3;11(8):e0160278. doi: 10.1371/journal.pone.0160278. eCollection 2016.
- Background: PubMed 26034987Ivaska L, Niemela J, Leino P, Mertsola J, Peltola V. Accuracy and feasibility of point-of-care white blood cell count and C-reactive protein measurements at the pediatric emergency department. PLoS One. 2015 Jun 2;10(6):e0129920. doi: 10.1371/journal.pone.0129920. eCollection 2015.
- Background: PubMed 15899661Esposito S, Tremolati E, Begliatti E, Bosis S, Gualtieri L, Principi N. Evaluation of a rapid bedside test for the quantitative determination of C-reactive protein. Clin Chem Lab Med. 2005;43(4):438-40. doi: 10.1515/CCLM.2005.077.
- Background: PubMed 18486458Cohen R, Lecuyer A, Wollner C, Deberdt P, Thollot F, Henriquet V, de La Rocque F. [Evaluation of impact of CRP rapid test in management of febrile children in ambulatory pediatric practice]. Arch Pediatr. 2008 Jun;15(6):1126-32. doi: 10.1016/j.arcped.2008.03.007. Epub 2008 May 16. French.
- Background: PubMed 17070024Cohen R, Romain O, Levy C, Perreaux F, Decobert M, Hau I, Lecuyer A, Lesprit E, Maman L, Roullaud S, Cheron G, Bekri A, d'Athis P, Henriquet V, de La Rocque F. [Impact of CRP rapid test in management of febrile children in paediatric emergency units of Ile-de-France]. Arch Pediatr. 2006 Dec;13(12):1566-71. doi: 10.1016/j.arcped.2006.09.003. Epub 2006 Oct 27. French.
- Background: PubMed 27495137Do NT, Ta NT, Tran NT, Than HM, Vu BT, Hoang LB, van Doorn HR, Vu DT, Cals JW, Chandna A, Lubell Y, Nadjm B, Thwaites G, Wolbers M, Nguyen KV, Wertheim HF. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial. Lancet Glob Health. 2016 Sep;4(9):e633-41. doi: 10.1016/S2214-109X(16)30142-5. Epub 2016 Aug 3.
- Background: PubMed 27230745Minnaard MC, van de Pol AC, Hopstaken RM, van Delft S, Broekhuizen BD, Verheij TJ, de Wit NJ. C-reactive protein point-of-care testing and associated antibiotic prescribing. Fam Pract. 2016 Aug;33(4):408-13. doi: 10.1093/fampra/cmw039. Epub 2016 May 26.
- Background: PubMed 22917039Verlee L, Verheij TJ, Hopstaken RM, Prins JM, Salome PL, Bindels PJ. [Summary of NHG practice guideline 'Acute cough']. Ned Tijdschr Geneeskd. 2012;156(0):A4188. Dutch.
- Individual participant dataSharing planned: No
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care with C-reactive protein assay in micro method in people with Respiratory Infection and Respiratory Infections in Children, run by Centre Hospitalier Intercommunal Creteil at 14 sites 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 6 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 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Frequency of antibiotic therapy prescribed (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540706, which also lists 22 linked publications.
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 7 Aug 2023.