EUCTR2019-004947-65-ES
Active, not recruiting
Phase 1
IMPACT ON THE CLINICAL OUTCOMES AND COST-EFFECTIVENESS OF THE ANTIMICROBIAL THERAPEUTIC MONITORING PROGRAM IN CRITICAL PATIENTS
Santiago Grau Cerrato0 sites230 target enrollmentSeptember 1, 2021
Conditions- Respiratory infections- Urogenital infections - Abdominal infectionsMedDRA version: 20.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10038700Term: Respiratory infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10065583Term: Urogenital infection bacterialSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- - Respiratory infections- Urogenital infections - Abdominal infections
- Sponsor
- Santiago Grau Cerrato
- Enrollment
- 230
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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