Pharmakokinetic investigation on the tissue penetration of moxifloxacin within the pericardial space

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-006051-39-DE

Enrollment

Registered

2009-02-16

Start date

2008-03-12

Completion date

Unknown

Last updated

2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with chronic pericardial effusion , 5 of them with pericardial effusion indiced by malignancies, 10 of them with chronic inflammatory pericardial effusion MedDRA version: 9.1 Level: PT Classification code 10034474 Term: Pericardial effusion

Interventions

Trade Name: Avalox Pharmaceutical Form: Solution for infusion INN or Proposed INN: Moxifloxacin CAS Number: 151096-09-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Key exclusion criteria: acute pericardial effusion or ecpected life time < 5 days, known flourochinolon allergy

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Safety; Decrease of the BNP-level ;Primary end point(s): Primary efficacy endpoint: measurement of moxifloxacin in the pericardial effusion and plasma Key secondary endpoint(s): measurement of BNP and proinflammatory cytokines in pericardial effusion and plasma ;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	—

Measure

Time frame

Secondary Objective: Safety; Decrease of the BNP-level ;Primary end point(s): Primary efficacy endpoint: measurement of moxifloxacin in the pericardial effusion and plasma Key secondary endpoint(s): measurement of BNP and proinflammatory cytokines in pericardial effusion and plasma ;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

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026