- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07703852
Pilot Study to Study the Time Between Pleuropulmonary Ultrasound and Antibiotic Therapy Prescription in Patients Admitted to the Emergency Department for Suspected Pneumonia (PRE-EPPA)
Study Overview
Status
Conditions
Detailed Description
The study will be conducted in the Emergency Department of grenoble University Hospital.
Patient admitted to the emergency department for respiratory symptoms (cough, fever, and/or dyspnea) will be enrolled in the study according to the inclusion and non-inclusion criteria and after obtaining his consent.
The investigator will perform the pleuropulmonary ultrasound following the clinical examination carried out by the physician in charge of the patient.
The patient's care is unaffected by the pleuropulmonary ultrasound's outcome, which is unknown to the physician in charge of the patient.
Data collection after the patient's discharge from the emergency department.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alice GREMBER, MD
- Phone Number: 0033476766784
- Email: AGrember@chu-grenoble.fr
Study Contact Backup
- Name: Marcelline BUFFIN
- Phone Number: 0033476766784
- Email: Mbuffin@chu-grenoble.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient over 18 years admitted the the emergency department of Grenoble Alpes University Hospital with respiratory symptoms (cough and/or dyspnea, fever).
- No objection by the subject to the study
- Affiliated to the french social security system (or equivalent)
Exclusion Criteria:
- Patient admitted to a life-threatening emergency
- Patient already on antibiotic therapy on admission
- Patient excluded from another study
- Patient with respiratory signs following chest trauma
- Unable to communicate or non-french speaking patients or those with impaired comprehension or consciousness
- Protected persons referred to in articles L1121-6 and L1121-8 of French public health code (deprived of liberty, tutorship or curatorship)
- The patient already enrolled in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient admitted for suspicion of Pneumonia
Patient admitted in emergency department of Grenoble Alpes University Hospital for suspicion of Pneumonia
|
In addition to the traditional management done by the physician at the patient's expense (such as clinical examination and paraclinical examinations like biology, chest X-ray, etc.), the investigator will perform pleuropulmonary ultrasound.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time between the antibiotic prescription and the pleuropulmonary ultrasonography used to detect pneumonia
Time Frame: 1 hour
|
Time between the antibiotic prescription and the pleuropulmonary ultrasonography used to detect pneumonia
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calculation of the predictive values of the pleuropulmonary ultrasound for pneumonia diagnosis
Time Frame: 1 day
|
Calculation of the predictive values of the pleuropulmonary ultrasound for pneumonia diagnosis: area under the curve, sensitivity, specificity, positive predictive value, negative predictive value.
|
1 day
|
|
duration of performing the pleuropulmonary ultrasound
Time Frame: 5 minutes
|
duration of performing the pleuropulmonary ultrasound
|
5 minutes
|
|
Time between the patient's admission to the emergency department and the completion of the pleuropulmonary ultrasound
Time Frame: 1 hour
|
Time between the patient's admission to the emergency department and the completion of the pleuropulmonary ultrasound
|
1 hour
|
|
4. Time between the performance of the pleuropulmonary ultrasound and the performance of the chest X-ray
Time Frame: 2 hours
|
4. Time between the performance of the pleuropulmonary ultrasound and the performance of the chest X-ray
|
2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alice GREMBER, MD, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC26.0148
- IDRCB :2026-A00930-51 (Other Identifier: CPP NORD OUEST IV (French Ethics Committees))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.
In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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