A study to determine antibiotic levels in the blood and lungs of patients in intensive care

Phase 1

• Conditions: Critical illness, ventilator associated pneumonia; MedDRA version: 14.1Level: LLTClassification code 10065153Term: Ventilator associated pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-004470-28-GB
• Lead Sponsor: niversity Hospital of South Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Subject is an adult aged 18 to 85
2.Subject requires or has been commenced on piperacillin/tazobactam as directed by clinical Intensive Care Unit medical staff

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Subject is known to be intolerant of ß-lactams antibiotics
2.Subject has an infection with a piperacillin/tazobactam resistant organism (i.e. P. aeruginosa with MIC =16 mg/L, other organism with MIC = 8mg/L) or organisms with inherent resistance (e.g. Stenotrophomonas)
3.Subject is immunocompromised (neutropenia, HIV/AIDS)
4.Subject is unlikely to survive longer the 48 hours
5.Subject is pregnant or breast-feeding or plans to become pregnant during the course of the study
6.Subject is enrolled in another Clinical Trial of an Investigational Medical Product.

Study & Design

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