Assessment of meropenem concentrations in lungs in patients with postoperative pneumonia.

Phase 1

• Conditions: Post-operative pneumonia; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-002796-10-ES
• Lead Sponsor: Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-27
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

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

Inclusion Criteria

• Patients of both genres aged older than 18 years old at the screening visit.
• Diagnosis of pneumonia in FRGMR post-operative patients . The diagnosis of pneumonia is based on clínical criteria and / or scores on the Clinical Infectious Pulmonary Score (PIACSS) = 6 points.
• Admission at theIntensive Care postoperative Unit (ICUPQ): The patient've been admited to ICUPQ after a surgical intervention and been developed a pneumonia during this insgress.
• Patients who have signed inform consent indicating that they have been informed regarding all the clinical trial aspects, or in the event that the subjects of the trial are incapacitated, signature of consent by the family member or legally designated representative.
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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

• Allergy or hypersensitivity to ß-lactamic antibiotics or any of the excipients of the drug clinical trial.
• Administration of carbapenemics antibiotics in the previous 15 days to inclusion of the study.
•Glomerular filtration <50 ml / min (GFR) (calculed by MDRD-4 formula (four-variable Modification of Diet in Renal Disease formula) or acute renal failure with renal indications of renal replacement.
• Severe disruption of the function, liver cirrhosis, defined as Class C según the classification of Child-Pugh.
• Obesity (BMI> 30).
• Known colonization with pathogens with resistance to meropenem.
• Life expectancy <3 days.
• Pregnant women or breast feeding.
• Participation in a clinical research dentro de los 3 months prior to administration of the drug.

Study & Design

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