EUCTR2014-003137-25-ES
Active, not recruiting
Not Applicable
Optimal duration of antibiotic treatment in patients with complicated parapneumonic pleural effusions or empyema: a randomized clinical trial - ODAPE
José Manuel Porcel Pérez Hospital Arnau de Vilanova de Lleida Servicio Medicina Interna0 sitesOctober 16, 2014
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Duration of antibiotic treatment in complicated parapneumonic pleural effusion and empyema.
- Sponsor
- José Manuel Porcel Pérez Hospital Arnau de Vilanova de Lleida Servicio Medicina Interna
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-18 years of age or older
- •\-Clinical evidence of CPPE; defined as a neutrophilic exudated in the context of
- •a community acquired pneumonia; or empyema, defined as the presence of pus
- •in pleural cavity. A CPPE required, according to the attending physician, a chest
- •tube drainage. Most patients will satisfy the following criteria: 1\) pleural fluid
- •pH \< 7\.2 or pleural fluid glucose \< 60 mg/dL, 2\) Gram\-positive or pleural fluid
- •positive culture or 3\) pleural effusion that occupy 50% or more of a hemithorax
- •in a thorax radiography or it is loculated in an image exploration (radiography,
- •ultrasound or computed tomography).
- •\-Clinical stability 2 weeks after diagnosis and antibiotic therapy beginning,
Exclusion Criteria
- •\-Pregnant women
- •\-Allergy for amoxicillin clavulanate
- •\-Immunosuppression: neutropenia, HIV infection, haematological neoplasms,
- •solid\-organ transplantation or steroids or immunosuppressive treatments.
- •\-Tuberculous pleural infection
- •\-Nosocomial\-, nursinghome\- or healthcare\-associated pneumonia.
- •\-Infection due to microorganisms that require alternative therapeutic regimens.
- •\-Life expectancy less than three months due to other causes.7\. Expected survival less than 3 months from other causes
- •8\. Patients who did not sign the informed consent
Outcomes
Primary Outcomes
Not specified
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