IMPACT ON THE CLINICAL OUTCOMES AND COST-EFFECTIVENESS OF THE ANTIMICROBIAL THERAPEUTIC MONITORING PROGRAM IN CRITICAL PATIENTS

Phase 1

• Conditions: - Respiratory infections- Urogenital infections - Abdominal infections; MedDRA version: 20.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: LLTClassification code 10038700Term: Respiratory infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10065583Term: Urogenital infection bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-004947-65-ES
• Lead Sponsor: Santiago Grau Cerrato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-01
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. Patients of both sexes over 18 years of age
2. Patients admitted to intensive care units with suspected or confirmed bacterial infection of respiratory, urological or abdominal focus
3. Patients being treated with linezolid, meropenem alone or in combination with each other, for at least 72 hours
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1. Pregnant or actively breastfeeding patients.
2. Patients receiving oral linezolid
3. Patients undergoing treatment with any renal replacement therapy or extracorporeal support.

Study & Design

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