Community-acquired PneumoniaPneumoCAPNCT03322670
Description of Pneumococcal Pneumonia
An observational study of Community-acquired Pneumonia, run by CNGE Conseil at 1 site in France.
Trial summary
Statement of the problem: Overprescription of antibiotics raises important public health issues because of the emergence of multiresistant bacteria by selection pressure. The results of the observational prospective study entitled "CAPA" on the description of 886 suspected cases of acute community-acquired pneumonia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Signs of CAP and a positive chest X-Ray, Patients directly hospitalized and Patients with partial participation
- How many people
- 412 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2017to 3 Jan 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In France, patients who visit a General Practitioner and who have clinical signs suggestive of CAP at clinic visits. For the control cohort, healthy patient who visit a General Practitioner in the two weeks following the inclusion of a patient with CAP confirmed on the chest X-ray
Who may be able to join
- Inclusion criteria for suspected CAP population:
- Age ≥18 years
- Presence of at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization):
- at least one sign of infection
- fever > 38.5°C (maximum temperature measured by the patient or GP)
- tachycardia > 100 /min
Show all 37Show fewer
- hyperpnea > 20/min
- global impression of severity*
- muscle aches, fatigue, or chills
- and at least one sign of pulmonary localization
- cough
- unilateral chest pain
- purulent or non-purulent sputum
- auscultatory abnormality compatible with CAP (focus of crackles)
- Affiliation with health insurance system
- Chest X-ray performed within 6 hours of presenting to the general practice
- Willing and capable of providing blood, oropharyngeal urine samples, and sputum sample, for filling self-administered questionnaires to D7 and D14 and to be contacted again on D28 and on D90 if necessary, if chest X-ray is positive.
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Inclusion criteria for who do not wish to participate in the full study or who have not received a chest X-ray
- Age ≥18 years
- Presence of at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization):
- at least one sign of infection
- fever > 38.5°C (maximum temperature measured by the patient or GP)
- tachycardia > 100 /min
- hyperpnea > 20/min
- global impression of severity*
- muscle aches, fatigue, or chills
- and at least one sign of pulmonary localization
- cough
- unilateral chest pain
- purulent or non-purulent sputum
- auscultatory abnormality compatible with CAP (focus of crackles)
- Control Inclusion Criteria
- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- A signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Age ≥18 years.
- Patients who are will to provide a urine sample
Who cannot join
- conditions of medical treatment not allowing for chest X-ray within 6 hours after diagnosis of CAP
- contraindication to chest X-ray
- conditions of medical management not allowing the realization of biological and bacteriological examinations within 8 hours of D0 consultation (except for patient immediately hospitalized)
- chest X-ray finding not compatible with CAP : chest X-ray showing another lung disease than a CAP (for example: pulmonary neoplasia, tuberculosis, pulmonary embolism)
- Control Exclusion Criteria
- Patients presenting with any of the following will not be included in the study:
Show all 14Show fewer
- Patients who are investigational site staff members or relatives of those site staff member or subjects who are Pfizer employees directly involved in the conduct of the trial.
- Patients with suspicion of CAP or other respiratory infectious diseases, as well as evidence of or documented concomitant infectious disease.
- Patients residing in any long-term care facilities (for example, nursing homes, respite care facilities, etc).
- Patients with known bronchial obstruction or a history of post-obstructive pneumonia. Chronic obstructive pulmonary disease (COPD) is permissible, provided there has not been an exacerbation within the 3 months prior to enrollment.
- Patients with primary lung cancer or another malignancy metastatic to the lungs.
- Patients with fever (measured temperature of ≥38.0° C measured by a healthcare provider).
- Patients with significant immunosuppressive disease such as AIDS, leukemia, etc.
- Patients with either pneumococcal conjugate vaccine (PCV) and/or pneumococcal polysaccharide vaccine (PPV) administration within the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of Pneumococcal Community-acquired Pneumonia in General Practice in France
Statement of the problem:
Overprescription of antibiotics raises important public health issues because of the emergence of multiresistant bacteria by selection pressure. The results of the observational prospective study entitled "CAPA" on the description of 886 suspected cases of acute community-acquired pneumonia (CAP) treated in general practices in France confirm that, whatever the etiologic hypothesis and the results of the chest X-ray, these patients routinely receive antibiotics. Therefore, it is important to be able to distinguish cases of pneumococcal CAP in which early antibiotic treatment is justified from those cases for which another strategy could be considered.
Read more
Primary objective:
To identify the clinical, biological and radiological characteristics of patients with pneumococcal CAP amongst all patients with CAP radiologically confirmed, in general practice in France.
Design :
Prospective cross-sectional descriptive study.
Inclusion criteria. Adults older than 18 showing clinical signs suggestive of CAP (at least one sign of infection and at least one pulmonary sign) and able to realize chest X ray within 6 hours after prescription.
Patient follow-up procedures. Patients will be treated by standard of care according to French recommendations. After observing clinical signs suggestive of CAP, the physician prescribes a chest X-ray. Then, protocol-specific examinations (blood sample, oropharyngeal sample for multiplex polymerase chain reaction (PCR), sputum sample testing (induced expectoration if possible), urinary sample) will be performed on all out patients. Patients will be contacted again on day 28 to increase diagnostic certainty. For patients with clinical signs of CAP and hospitalized, the investigator will ask their consent to retrieve the hospital report, on or before day 28 and to be contacted on day 90.
Read the detailed description
The aim of the study is to enroll approximately 2000 patients with CAP in total. Approximately 1000 X-ray positive patients and 1000 X-ray negative patients will be enrolled over 18 months.
Investigating GPs will identify patients with clinical signs suggestive of CAP at clinic visits.
A chest X-ray will be prescribed in accordance with local standard of care practices for patients that do not require immediate hospitalization. Chest X-ray must be completed within the 6 hours following its prescription.
For the 1000 patients (patient enrolment will be monitored centrally) with a positive chest X-ray, all procedures will be undertaken according to the protocol. Patients will attend the local medical analysis laboratory for biological sample collection (blood, sputum, oropharyngeal swab for the PCR, and urine). If a patient has taken antibiotics prior to the clinic visit at which CAP is suspected, will only have urine samples collected.
As a diagnostic confirmation of the chest X-ray assessments, for the 1000 patients for whom the local radiologist will have diagnosed a parenchymal opacity compatible with CAP, 200 patients will be randomly selected by the clinical research organization (CRO Paris Descartes Necker Cochin). A central independent thoracic radiologist expert will re-read their chest X-ray. In case of insufficient agreement, all chest X-rays will be re-read.
Patients will be asked to complete and return a self-assessment questionnaire at day 7 (D7) and at day 14 (D14) on the number of work days missed, if any, interruption of occupational activity, and the number of days of restricted everyday activities or recreational.
Patients will be contacted by telephone at day 28, and day 90 if they are hospitalized between day 0 and day 28.
For the 1000 patients (patient enrolment will be monitored centrally) with a negative chest X-ray, no medical analysis will be performed. Only clinical examination data will be recorded. Patients will be contacted by telephone at day 28.
For patients who will be directly hospitalized before the completion of the additional examinations, they will be contacted by telephone at day 28 to retrieve the hospitalization report and at day 90.
Control Patients will be included for the assessment of Pneumococcal urine antigen detection (UAD) Assay: in the two weeks following the inclusion of a patient with CAP, investigators should include a control patient according to the control patient inclusion / exclusion criteria. For these healthy patients, the number of inclusion is limited to 400.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Signs of CAP and a positive chest X-Ray, Patients directly hospitalized, Control patients, Patients with partial participation, Signs of CAP and a negative chest X-Ray
- Keywords
- community-acquired pneumonia, family practice, streptococcus pneumoniae
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signs of CAP and a positive chest X-RayOther
- collection of clinical examination data
- biological and bacteriological examinations (blood, urine, sputum, nasopharyngeal)
- self-reported questionnaires on duration of symptoms and restriction of activity
- telephone contact on day 28 and day 90 if hospitalized before day 28
Patients directly hospitalizedOther
- collection of clinical examination data
- telephone contact on day 28 and retrieval of hospitalization report
- telephone contact on day 90
Control patientsDiagnostic test
- bacteriological examinations (urine)
Patients with partial participationOther
- collection of clinical examination data
Signs of CAP and a negative chest X-RayOther
- collection of clinical examination data
- telephone contact on day 28
| Study group | Role | What they receive |
|---|---|---|
| Signs of CAP and a positive chest X-Ray | Patients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and and a chest X-Ray not compatible with CAP Receives: Other: Signs of CAP and a positive chest X-Ray | |
| Patients directly hospitalized | Patients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and and who are directly hospitalized before complementary examinations Receives: Other: Patients directly hospitalized | |
| Control patients | Healthy Patients (age-matched with a radiologically confirmed CAP patient) Receives: Diagnostic Test: Control patients | |
| Patients with partial participation | Patients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and who can not or do not want to perform all the complementary examinations of the study Receives: Other: Patients with partial participation | |
| Signs of CAP and a negative Chest X-Ray | Patients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and and a chest X-Ray not compatible with CAP Receives: Other: Signs of CAP and a negative chest X-Ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pneumococcal CAP amongst the other etiological CAP with a positive chest X-ray
Determination oh the proportion of pneumococcal CAP among all CAP radiologically confirmed with other etiologies identified, followed in general practice in France. Comparison of the clinical, biological and radiological characteristics of patients with radiologically confirmed pneumococcal CAP to those with radiologically confirmed CAP patients for whom another microbiological etiology was identified
Measured: Day 0
Secondary outcomes (1)
Description of clinical characteristics of patients treated in general practice for a radiologically confirmed CAP, based on the microbiological etiologies
Number and percentage of each of the clinical characteristics according to the microbiological etiology according to the presence or not of a sepsis and according to an hospitalization or not
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start21 Dec 2017
- Primary completion6 Dec 2019
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- CNGE Conseil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GILBERG SERGE, CNGE Conseil
- Investigators
- Serge Gilberg, Professor, Principal investigator, University Paris Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322670
- Sponsor's protocol ID
- N° ID RCB : 2016-A01537-44
- Acronym
- PneumoCAP
- Status last verified
- Feb 2021
- First submitted
- 25 Sep 2017
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hosker H, Cooke NJ, Hawkey P. Antibiotics in chronic obstructive pulmonary disease. BMJ. 1994 Apr 2;308(6933):871-2. doi: 10.1136/bmj.308.6933.871. No abstract available.
PubMed 8173363Wipf JE, Lipsky BA, Hirschmann JV, Boyko EJ, Takasugi J, Peugeot RL, Davis CL. Diagnosing pneumonia by physical examination: relevant or relic? Arch Intern Med. 1999 May 24;159(10):1082-7. doi: 10.1001/archinte.159.10.1082.
PubMed 10335685Jackson ML, Neuzil KM, Thompson WW, Shay DK, Yu O, Hanson CA, Jackson LA. The burden of community-acquired pneumonia in seniors: results of a population-based study. Clin Infect Dis. 2004 Dec 1;39(11):1642-50. doi: 10.1086/425615. Epub 2004 Nov 8.
PubMed 15578365Holm A, Nexoe J, Bistrup LA, Pedersen SS, Obel N, Nielsen LP, Pedersen C. Aetiology and prediction of pneumonia in lower respiratory tract infection in primary care. Br J Gen Pract. 2007 Jul;57(540):547-54.
PubMed 17727747Porath A, Schlaeffer F, Lieberman D. The epidemiology of community-acquired pneumonia among hospitalized adults. J Infect. 1997 Jan;34(1):41-8. doi: 10.1016/s0163-4453(97)80008-4.
PubMed 9120323Said MA, Johnson HL, Nonyane BA, Deloria-Knoll M, O'Brien KL; AGEDD Adult Pneumococcal Burden Study Team; Andreo F, Beovic B, Blanco S, Boersma WG, Boulware DR, Butler JC, Carratala J, Chang FY, Charles PG, Diaz AA, Dominguez J, Ehara N, Endeman H, Falco V, Falguera M, Fukushima K, Garcia-Vidal C, Genne D, Guchev IA, Gutierrez F, Hernes SS, Hoepelman AI, Hohenthal U, Johansson N, Kolek V, Kozlov RS, Lauderdale TL, Marekovic I, Masia M, Matta MA, Miro O, Murdoch DR, Nuermberger E, Paolini R, Perello R, Snijders D, Plecko V, Sorde R, Stralin K, van der Eerden MM, Vila-Corcoles A, Watt JP. Estimating the burden of pneumococcal pneumonia among adults: a systematic review and meta-analysis of diagnostic techniques. PLoS One. 2013;8(4):e60273. doi: 10.1371/journal.pone.0060273. Epub 2013 Apr 2.
PubMed 23565216Musher DM, Thorner AR. Community-acquired pneumonia. N Engl J Med. 2014 Oct 23;371(17):1619-28. doi: 10.1056/NEJMra1312885. No abstract available.
PubMed 25337751Dorca J, Torres A. Lower respiratory tract infections in the community: towards a more rational approach. Eur Respir J. 1996 Aug;9(8):1588-9. doi: 10.1183/09031936.96.09081588. No abstract available.
PubMed 8866576Gennis P, Gallagher J, Falvo C, Baker S, Than W. Clinical criteria for the detection of pneumonia in adults: guidelines for ordering chest roentgenograms in the emergency department. J Emerg Med. 1989 May-Jun;7(3):263-8. doi: 10.1016/0736-4679(89)90358-2.
PubMed 2745948Metlay JP, Fine MJ. Testing strategies in the initial management of patients with community-acquired pneumonia. Ann Intern Med. 2003 Jan 21;138(2):109-18. doi: 10.7326/0003-4819-138-2-200301210-00012.
PubMed 12529093Partouche H, Buffel du Vaure C, Personne V, Le Cossec C, Garcin C, Lorenzo A, Ghasarossian C, Landais P, Toubiana L, Gilberg S. Suspected community-acquired pneumonia in an ambulatory setting (CAPA): a French prospective observational cohort study in general practice. NPJ Prim Care Respir Med. 2015 Mar 12;25:15010. doi: 10.1038/npjpcrm.2015.10.
PubMed 25763466Young M, Marrie TJ. Interobserver variability in the interpretation of chest roentgenograms of patients with possible pneumonia. Arch Intern Med. 1994 Dec 12-26;154(23):2729-32. doi: 10.1001/archinte.1994.00420230122014.
PubMed 7993157Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
PubMed 26168322Ortqvist A, Hedlund J, Wretlind B, Carlstrom A, Kalin M. Diagnostic and prognostic value of interleukin-6 and C-reactive protein in community-acquired pneumonia. Scand J Infect Dis. 1995;27(5):457-62. doi: 10.3109/00365549509047046.
PubMed 8588135Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8.
PubMed 14987884
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Pneumococcal Community-acquired Pneumonia in General Practice in France
- ClinicalTrials.gov ID
- NCT03322670
- Acronym / sponsor ID
- PneumoCAP / N° ID RCB : 2016-A01537-44
- Conditions
- Community-acquired Pneumonia
- Keywords
- community-acquired pneumonia, family practice, streptococcus pneumoniae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- CNGE ConseilUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 26 Oct 2017 (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.
Statement of the problem:
Overprescription of antibiotics raises important public health issues because of the emergence of multiresistant bacteria by selection pressure. The results of the observational prospective study entitled "CAPA" on the description of 886 suspected cases of acute community-acquired pneumonia (CAP) treated in general practices in France confirm that, whatever the etiologic hypothesis and the results of the chest X-ray, these patients routinely receive antibiotics. Therefore, it is important to be able to distinguish cases of pneumococcal CAP in which early antibiotic treatment is justified from those cases for which another strategy could be considered.
Primary objective:
To identify the clinical, biological and radiological characteristics of patients with pneumococcal CAP amongst all patients with CAP radiologically confirmed, in general practice in France.
Design :
Prospective cross-sectional descriptive study.
Inclusion criteria. Adults older than 18 showing clinical signs suggestive of CAP (at least one sign of infection and at least one pulmonary sign) and able to realize chest X ray within 6 hours after prescription.
Patient follow-up procedures. Patients will be treated by standard of care according to French recommendations. After observing clinical signs suggestive of CAP, the physician prescribes a chest X-ray. Then, protocol-specific examinations (blood sample, oropharyngeal sample for multiplex polymerase chain reaction (PCR), sputum sample testing (induced expectoration if possible), urinary sample) will be performed on all out patients. Patients will be contacted again on day 28 to increase diagnostic certainty. For patients with clinical signs of CAP and hospitalized, the investigator will ask their consent to retrieve the hospital report, on or before day 28 and to be contacted on day 90.
Detailed description
The aim of the study is to enroll approximately 2000 patients with CAP in total. Approximately 1000 X-ray positive patients and 1000 X-ray negative patients will be enrolled over 18 months.
Investigating GPs will identify patients with clinical signs suggestive of CAP at clinic visits.
A chest X-ray will be prescribed in accordance with local standard of care practices for patients that do not require immediate hospitalization. Chest X-ray must be completed within the 6 hours following its prescription.
For the 1000 patients (patient enrolment will be monitored centrally) with a positive chest X-ray, all procedures will be undertaken according to the protocol. Patients will attend the local medical analysis laboratory for biological sample collection (blood, sputum, oropharyngeal swab for the PCR, and urine). If a patient has taken antibiotics prior to the clinic visit at which CAP is suspected, will only have urine samples collected.
As a diagnostic confirmation of the chest X-ray assessments, for the 1000 patients for whom the local radiologist will have diagnosed a parenchymal opacity compatible with CAP, 200 patients will be randomly selected by the clinical research organization (CRO Paris Descartes Necker Cochin). A central independent thoracic radiologist expert will re-read their chest X-ray. In case of insufficient agreement, all chest X-rays will be re-read.
Patients will be asked to complete and return a self-assessment questionnaire at day 7 (D7) and at day 14 (D14) on the number of work days missed, if any, interruption of occupational activity, and the number of days of restricted everyday activities or recreational.
Patients will be contacted by telephone at day 28, and day 90 if they are hospitalized between day 0 and day 28.
For the 1000 patients (patient enrolment will be monitored centrally) with a negative chest X-ray, no medical analysis will be performed. Only clinical examination data will be recorded. Patients will be contacted by telephone at day 28.
For patients who will be directly hospitalized before the completion of the additional examinations, they will be contacted by telephone at day 28 to retrieve the hospitalization report and at day 90.
Control Patients will be included for the assessment of Pneumococcal urine antigen detection (UAD) Assay: in the two weeks following the inclusion of a patient with CAP, investigators should include a control patient according to the control patient inclusion / exclusion criteria. For these healthy patients, the number of inclusion is limited to 400.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Signs of CAP and a positive chest X-Ray | – | Other: Signs of CAP and a positive chest X-RayPatients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and and a chest X-Ray not compatible with CAP |
| Patients directly hospitalized | – | Other: Patients directly hospitalizedPatients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and and who are directly hospitalized before complementary examinations |
| Control patients | – | Diagnostic Test: Control patientsHealthy Patients (age-matched with a radiologically confirmed CAP patient) |
| Patients with partial participation | – | Other: Patients with partial participationPatients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and who can not or do not want to perform all the complementary examinations of the study |
| Signs of CAP and a negative Chest X-Ray | – | Other: Signs of CAP and a negative chest X-RayPatients with at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization) and and a chest X-Ray not compatible with CAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In France, patients who visit a General Practitioner and who have clinical signs suggestive of CAP at clinic visits. For the control cohort, healthy patient who visit a General Practitioner in the two weeks following the inclusion of a patient with CAP confirmed on the chest X-ray
Key inclusion criteria (37 listed)
- Inclusion criteria for suspected CAP population:
- Age ≥18 years
- Presence of at least 2 signs suggestive of CAP on presentation at general practice (one general sign of infection and one sign of pulmonary localization):
- Affiliation with health insurance system
- Chest X-ray performed within 6 hours of presenting to the general practice
Key exclusion criteria (14 listed)
- Control Exclusion Criteria
- Patients who are investigational site staff members or relatives of those site staff member or subjects who are Pfizer employees directly involved in the conduct of the trial.
- Patients with suspicion of CAP or other respiratory infectious diseases, as well as evidence of or documented concomitant infectious disease.
- Patients residing in any long-term care facilities (for example, nursing homes, respite care facilities, etc).
- Patients with known bronchial obstruction or a history of post-obstructive pneumonia. Chronic obstructive pulmonary disease (COPD) is permissible, provided there has not been an exacerbation within the 3 months prior to enrollment.
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 |
|---|---|---|
| Signs of CAP and a positive chest X-Ray* collection of clinical examination data * biological and bacteriological examinations (blood, urine, sputum, nasopharyngeal) * self-reported questionnaires on duration of symptoms and restriction of activity * telephone contact on day 28 and day 90 if hospitalized before day 28 | Other | Signs of CAP and a positive chest X-Ray |
| Patients directly hospitalized* collection of clinical examination data * telephone contact on day 28 and retrieval of hospitalization report * telephone contact on day 90 | Other | Patients directly hospitalized |
| Control patients- bacteriological examinations (urine) | Diagnostic test | Control patients |
| Patients with partial participation- collection of clinical examination data | Other | Patients with partial participation |
| Signs of CAP and a negative chest X-Ray* collection of clinical examination data * telephone contact on day 28 | Other | Signs of CAP and a negative Chest X-Ray |
Primary outcome
Percentage of pneumococcal CAP amongst the other etiological CAP with a positive chest X-ray
Time frame: Day 0
Determination oh the proportion of pneumococcal CAP among all CAP radiologically confirmed with other etiologies identified, followed in general practice in France. Comparison of the clinical, biological and radiological characteristics of patients with radiologically confirmed pneumococcal CAP to those with radiologically confirmed CAP patients for whom another microbiological etiology was identified
1 secondary outcome
Description of clinical characteristics of patients treated in general practice for a radiologically confirmed CAP, based on the microbiological etiologies
Time frame: Day 0
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 12 Feb 2021.
- Background: PubMed 8173363Hosker H, Cooke NJ, Hawkey P. Antibiotics in chronic obstructive pulmonary disease. BMJ. 1994 Apr 2;308(6933):871-2. doi: 10.1136/bmj.308.6933.871. No abstract available.
- Background: PubMed 10335685Wipf JE, Lipsky BA, Hirschmann JV, Boyko EJ, Takasugi J, Peugeot RL, Davis CL. Diagnosing pneumonia by physical examination: relevant or relic? Arch Intern Med. 1999 May 24;159(10):1082-7. doi: 10.1001/archinte.159.10.1082.
- Background: PubMed 15578365Jackson ML, Neuzil KM, Thompson WW, Shay DK, Yu O, Hanson CA, Jackson LA. The burden of community-acquired pneumonia in seniors: results of a population-based study. Clin Infect Dis. 2004 Dec 1;39(11):1642-50. doi: 10.1086/425615. Epub 2004 Nov 8.
- Background: PubMed 17727747Holm A, Nexoe J, Bistrup LA, Pedersen SS, Obel N, Nielsen LP, Pedersen C. Aetiology and prediction of pneumonia in lower respiratory tract infection in primary care. Br J Gen Pract. 2007 Jul;57(540):547-54.
- Background: PubMed 9120323Porath A, Schlaeffer F, Lieberman D. The epidemiology of community-acquired pneumonia among hospitalized adults. J Infect. 1997 Jan;34(1):41-8. doi: 10.1016/s0163-4453(97)80008-4.
- Background: PubMed 23565216Said MA, Johnson HL, Nonyane BA, Deloria-Knoll M, O'Brien KL; AGEDD Adult Pneumococcal Burden Study Team; Andreo F, Beovic B, Blanco S, Boersma WG, Boulware DR, Butler JC, Carratala J, Chang FY, Charles PG, Diaz AA, Dominguez J, Ehara N, Endeman H, Falco V, Falguera M, Fukushima K, Garcia-Vidal C, Genne D, Guchev IA, Gutierrez F, Hernes SS, Hoepelman AI, Hohenthal U, Johansson N, Kolek V, Kozlov RS, Lauderdale TL, Marekovic I, Masia M, Matta MA, Miro O, Murdoch DR, Nuermberger E, Paolini R, Perello R, Snijders D, Plecko V, Sorde R, Stralin K, van der Eerden MM, Vila-Corcoles A, Watt JP. Estimating the burden of pneumococcal pneumonia among adults: a systematic review and meta-analysis of diagnostic techniques. PLoS One. 2013;8(4):e60273. doi: 10.1371/journal.pone.0060273. Epub 2013 Apr 2.
- Background: PubMed 25337751Musher DM, Thorner AR. Community-acquired pneumonia. N Engl J Med. 2014 Oct 23;371(17):1619-28. doi: 10.1056/NEJMra1312885. No abstract available.
- Background: PubMed 8866576Dorca J, Torres A. Lower respiratory tract infections in the community: towards a more rational approach. Eur Respir J. 1996 Aug;9(8):1588-9. doi: 10.1183/09031936.96.09081588. No abstract available.
- Background: PubMed 2745948Gennis P, Gallagher J, Falvo C, Baker S, Than W. Clinical criteria for the detection of pneumonia in adults: guidelines for ordering chest roentgenograms in the emergency department. J Emerg Med. 1989 May-Jun;7(3):263-8. doi: 10.1016/0736-4679(89)90358-2.
- Background: PubMed 12529093Metlay JP, Fine MJ. Testing strategies in the initial management of patients with community-acquired pneumonia. Ann Intern Med. 2003 Jan 21;138(2):109-18. doi: 10.7326/0003-4819-138-2-200301210-00012.
- Background: PubMed 25763466Partouche H, Buffel du Vaure C, Personne V, Le Cossec C, Garcin C, Lorenzo A, Ghasarossian C, Landais P, Toubiana L, Gilberg S. Suspected community-acquired pneumonia in an ambulatory setting (CAPA): a French prospective observational cohort study in general practice. NPJ Prim Care Respir Med. 2015 Mar 12;25:15010. doi: 10.1038/npjpcrm.2015.10.
- Background: PubMed 7993157Young M, Marrie TJ. Interobserver variability in the interpretation of chest roentgenograms of patients with possible pneumonia. Arch Intern Med. 1994 Dec 12-26;154(23):2729-32. doi: 10.1001/archinte.1994.00420230122014.
- Related InfoLink provided by the sponsor.
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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.
Serge Gilberg, Professor principal investigator
University Paris Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by CNGE Conseil 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 37 inclusion and 14 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 12 Feb 2021. 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?
Percentage of pneumococcal CAP amongst the other etiological CAP with a positive chest X-ray (time frame: Day 0). 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 NCT03322670, which also lists 30 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 12 Feb 2021.