Optimal duration of antibiotic treatment in patients with complicated parapneumonic pleural effusions or empyema

• Conditions: Duration of antibiotic treatment in complicated parapneumonic pleural effusion and empyema.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-003137-25-ES
• Lead Sponsor: José Manuel Porcel Pérez Hospital Arnau de Vilanova de Lleida Servicio Medicina Interna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-16
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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,

defined as: 1) absence of fever (temperature < 37.8oC), heart rate < 100 bpm,

breath rate < 24 bpm and systolic blood pressure > 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 <37.8 ° C, HR <100 bpm FR <24 rpm and SBP> 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

-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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 <br><br>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 Outcome Measures

Name	Time	Method
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.