Pharmakokinetic investigation on the tissue penetration of moxifloxacin within the pericardial space
- Conditions
- Patients with chronic pericardial effusion , 5 of them with pericardial effusion indiced by malignancies, 10 of them with chronic inflammatory pericardial effusionMedDRA version: 9.1Level: PTClassification code 10034474Term: Pericardial effusion
- Registration Number
- EUCTR2007-006051-39-DE
- Lead Sponsor
- Philipps Universität Marburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Key inclusion criteria: age between 18-85y, presence of a moderate or large pericardial effusion (Horowitz c or D class) due to malignancies or chronic inflammatory pericarditis
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Key exclusion criteria: acute pericardial effusion or ecpected life time < 5 days, known flourochinolon allergy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Safety; Decrease of the BNP-level<br>;Primary end point(s): Primary efficacy endpoint: measurement of moxifloxacin in the pericardial effusion and plasma<br>Key secondary endpoint(s): measurement of BNP and proinflammatory cytokines in pericardial effusion and plasma<br>;Main Objective: To obtain data on the tissue penetration of moxofloxacin after i.v. application by measurement of moxofloxacin within the pericardial effusion and serum of the patients at day 4 after starting of the therapy. Concentration of Moxifloxacin inPE and SE
- Secondary Outcome Measures
Name Time Method