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Pharmacokinetic and colimicine (ColistinaR) concentrations in broncho alveolar lavage in patients affected by pulmonary infections caused by Gram - bacteria. - ND

Pharmacokinetic and colimicine (ColistinaR) concentrations in broncho alveolar lavage in patients affected by pulmonary infections caused by Gram - bacteria. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005045-38-IT
Enrollment
Unknown
Registered
2007-11-22
Start date
2007-10-02
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

pulmonary disease caused by Gram - infection MedDRA version: 9.1 Level: LLT Classification code 10061229 Term: Lung infection

Interventions

Trade Name: COLIMICINA Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Colistin Concentration unit: U unit(s) Concentration type: equal Concentration number: 10

Sponsors

OSPEDALE POLICLINICO S. MATTEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: age > 18 years, patient with pulmonary infection, needing respiratory assistance, secretion containing Gram - 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: age < 18 years, patient with known sensibility to colimicine, pregnant woman

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate the colimicine (ColistinaR) pharmacokinetic, assessed by specific HPLC method, measuring plasma, urine and epitelial lining fluid (ELF)(obtained by broncho alveolar lavage) concentrations in patients affected by bacterical Gram - pneumonia.;Secondary Objective: not specified;Primary end point(s): to evaluate colimicine pharmacokinetic and pharmacodinamic parameters (in particular ELF concentration) in ventilated patient, with pulmonary infection in critical conditions—

Countries

Italy

Outcome results

None listed

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