Impact of a molecular microbiology test for the diagnosis of pneumonia's cause in the use of antimicrobials

Phase 1

Active, not recruiting

• Conditions: Community-acquired pneumonia (CAP); MedDRA version: 20.0 Level: PT Classification code 10035664 Term: Pneumonia System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-004880-29-ES
• Lead Sponsor: Dr. Jordi Carratalà Fernández (Servicio de Enfermedades Infecciosas) del Hospital Universitario de Bellvitge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 440

Inclusion Criteria

•Adult patients (18 years of age or older), of both sexes, hospitalized with a diagnosis of CAP during first 24 hours since emergency department arrival.
•Patient or his legal representative gives the informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 146
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 294

Exclusion Criteria

•Pregnancy and / or nursing.
•Severe immunocompromised patients (eg, chemotherapy or radiotherapy in the previous 90 days, use of immunosuppressive drugs, chronic use of corticosteroids at a minimum dose of 15 mg / day in the last two weeks, transplantation of hematopoietic progenitors, solid organ transplant, HIV patients with CD4 = 200 cells / mm3)
•Imminent death (life expectancy = 24h)
•Congestive heart failure (NYHA class 3 or 4).
• Participation in another clinical trial of pharmacological treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified