- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Alice GREMBER, MD
- Telefonnummer: 0033476766784
- E-post: AGrember@chu-grenoble.fr
Studer Kontakt Backup
- Navn: Marcelline BUFFIN
- Telefonnummer: 0033476766784
- E-post: Mbuffin@chu-grenoble.fr
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time between the antibiotic prescription and the pleuropulmonary ultrasonography used to detect pneumonia
Tidsramme: 1 hour
|
Time between the antibiotic prescription and the pleuropulmonary ultrasonography used to detect pneumonia
|
1 hour
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Calculation of the predictive values of the pleuropulmonary ultrasound for pneumonia diagnosis
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 2 hours
|
4. Time between the performance of the pleuropulmonary ultrasound and the performance of the chest X-ray
|
2 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Alice GREMBER, MD, University Hospital, Grenoble
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 38RC26.0148
- IDRCB :2026-A00930-51 (Annen identifikator: CPP NORD OUEST IV (French Ethics Committees))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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