Duration of antibiotic treatment in complicated parapneumonic pleural effusion and empyema.
Conditions
Interventions
Trade Name: Ardineclav 875mg/125mg
Pharmaceutical Form: Powder for use in drinking water
INN or Proposed INN: CLAVULANIC ACID
CAS Number: 58001-44-8
Current Sponsor code: Reig Jofré, S.A.
Concentratio
Sponsors
José Manuel Porcel Pérez Hospital Arnau de Vilanova de Lleida Servicio Medicina Interna
Eligibility
Sex/Gender
All
Inclusion 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 90 mmHg. 2) Thorax radiography without pleural effusion or that occupy less than 20% of the hemithorax without chest tube in that moment. 3) Serum C-reactive protein drop of at least 50% from the diagnosis. -Capable of giving written informed consent. 3. Clinical stability at 2 weeks of diagnosis and treatment with amoxicillin-clavulanate of DPPC or empyema. This must meet three requirements: 1) in the past 48 hours: T ª 90 mmHg, 2) pleural effusion on chest radiograph occupying less than 20% of the hemithorax with pleural drainage and retired at the time, and 3) decrease in serum C-reactive protein of at least 50% from diagnosis. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To show that antibiotic treatment for 2 weeks is non-inferior to 3 weeks of treatment in patients with complicated parapneumonic pleural effusion or empyema.;Secondary Objective: To assess the impact of adjuvant treatment with NSAIDs in clinical and radiological resolution of DPPC or empyema.;Primary end point(s): ?healing?: clinical and radiological resolution 3 months alter the beginning of the antibiotic treatment and without pleural infection symptoms or signs .;Timepoint(s) of evaluation of this end point: Three months after the beginning of the antibiotic treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the residual pleural thickening;Timepoint(s) of evaluation of this end point: Three months after the beginning of the antibiotic treatment. | — |
Countries
Spain
Contacts
Public ContactInv.
José Manuel Porcel Pérez Hospital Arnau de Vilanova de Lleida Servicio Medicina Interna
Outcome results
None listed