Levofloxacin vs piperacillin/sulbactam and sultamicillin in patients with bacterial cholangitis: A double-blind, randomised study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90588401

Enrollment

128

Registered

2008-04-30

Start date

2007-05-02

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Bacterial cholangitis Infections and Infestations Bacterial cholangitis

Interventions

Control group: Piperacillin 4 g/sulbactam 1 g intravenously (i.v.) 3 x daily for 2 days, then sultamicillin 0.75 g orally (p.o.) 2 x daily for 2-8 days. Experimental group: Levofloxacin 0.5 g i.v. 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinical signs of bacterial cholangitis 2. Elevated cholestase parameters 3. Elevated infection parameters 4. Age 18-90 years

Exclusion criteria

Exclusion criteria: 1. Potential other cause of infection 2. Pregnancy 3. Psychiatric disease 4. Penicillin incompatibillity 5. Fluorochinolon incompatibillity 6. Leucopenia 7. Immunosuppressive medication 8. AIDS 9. Liver cirrhosis 10. Microbiological resistance against study medication 11. Biliary pancreatitis 12. Antibiotic pre-treatment within 48 hour before study inclusion

Design outcomes

Primary

Measure	Time frame
Number of days in hospital (in-patient)	—

Secondary

Measure	Time frame
1. Change of antibiotic therapy, recorded during the treatment 2. Duration of antibiotic therapy during the interventions 3. Fever, monitored during the treatment 4. Laboratory parameters 5. Complications of antibiotic therapy during the treatment	—

Countries

Germany

Outcome results

None listed

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