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Levofloxacin vs Piperacillin/Sulbactam and Sultamicillin in patients with bacterial cholangitis. A double blind, randomiized study. - LAPIS

Levofloxacin vs Piperacillin/Sulbactam and Sultamicillin in patients with bacterial cholangitis. A double blind, randomiized study. - LAPIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004122-90-DE
Enrollment
Unknown
Registered
2006-12-14
Start date
2007-03-21
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

bacterial cholangitis

Interventions

Sponsors

Medizinische Fakultät der Technischen Universität München, Vertreten durch den Dekan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - clinical signs of bacterial cholangitis - elevated cholestase parameters - elevated infection parameters - age 18 - 90 years 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: - potential other cause of infection - pregnancy - psychiatric disease - Penicillin incompatibillity - Fluorochinolon incompatibillity - leucopenia - immunosuppressive medication - AIDS - liver cirrhosis - microbiological restistance against study medication - biliary pancreatitis - antibiotic pretreatment within 48 hour before study inclusion

Design outcomes

Primary

MeasureTime frame
Main Objective: number of days in hospiatl (in-patient);Secondary Objective: - change of antibiotic therapy - duration of antibiotic therapy - fever - laboratory parameters - complications of antibiotic therapy;Primary end point(s): number of days in hospital (in-patient)

Countries

Germany

Outcome results

None listed

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