Trials / Completed
CompletedNCT01265173
Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC
Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 261 (actual)
- Sponsor
- Korea University · Academic / Other
- Sex
- All
- Age
- 16 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis. The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.
Detailed description
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis. The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore 87 patients for each group are needed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cefotaxime | 3 g |
| DRUG | Ceftriaxone | 2 g |
| DRUG | Ciprofloxacin | 400 mg |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2010-12-23
- Last updated
- 2020-04-06
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01265173. Inclusion in this directory is not an endorsement.