CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 412 enrolled
Drug / intervention
Signs of CAP and a positive chest X-Ray +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03322670
NCT03322670N/ACompleted

Description of Pneumococcal Community-acquired Pneumonia in General Practice in France

CNGE Conseil·observational·Posted Oct 26, 2017·Updated Feb 12, 2021

In Brief

An observational study evaluating Signs of CAP and a positive chest X-Ray, Patients directly hospitalized, and 3 other interventions for Community-acquired Pneumonia. Completed, enrolled 412 participants across 1 site.

Detailed 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 (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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 26, 2017
Enrollment StartDec 21, 2017
Primary CompletionDec 6, 2019
Study CompletionJan 3, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.7 years ago

Interventions

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 patientsother

\- 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