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NCT Number: NCT01265173

Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC

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.

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Key information

Conditions

SBP Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Ansan Hospital, Ansan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver cirrhosis patients with ascites
  • Ascitic fluid PMN cell count >250/mm3
  • Age: 16~70 years old

Exclusion criteria

  • Allergic to 3rd generation cephalosporin or quinolone
  • Antibiotics within 2 weeks
  • Open abdominal surgery within 4 weeks
  • Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis
  • HCC with portal vein thrombosis
  • Pregnant woman
  • HIV positive

Treatment and study plan

Cefotaxime

Drug

3 g

Ceftriaxone

Drug

2 g

Ciprofloxacin

Drug

400 mg

Primary outcomes

  1. Infection resolution rates within 5 days of treatment

    Time frame: 5 days (120 hours)

    PMN < 250/mm3 from ascitic fluid

Secondary outcomes

  1. Mortality & recurrence rates within 1 month

    Time frame: 1 month

    Mortality

Sponsors and collaborators

Lead sponsor

Korea University

Other

Registry information

Official study title

Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Dec 23, 2010
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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