Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention

NCT01542801 | Completed Phase 4 DMC

• 1 other identifier: SBP_prevention
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 7

Brief Summary

• For the prevention of spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis, norfloxacin 400mg per day is a standard regimen.
• Ciprofloxacin 750 mg per week is also known to be effective for prevention of SBP. In addition, ciprofloxacin once weekly administration is more convenient and less costly.
• Therefore ciprofloxacin once weekly could be more useful if the the efficacy is comparable to norfloxacin once daily.
• This study aims to prove ciprofloxacin once weekly administration is as effective as norfloxacin once daily administration for the prevention of SBP in cirrhotic patients with ascites.

Conditions

Adverse Reaction to Other Drugs and Medicines

Keywords

Effect of Preventive Antibiotics

Outcome Measures

Primary Outcomes (1)

• The prevention rate of spontaneous bacterial peritonitis (SBP)

  The incidence of SBP will measured in each the group. Thereby, prevention rate will also be compared between the groups.

  12 months

Secondary Outcomes (5)

• 1 year mortality

  12 months ( 1 year)

• Incidence of infectious event other than SBP

  12 months

• Hepatorenal syndrome

  12 months

• Hepatic encephalopathy

  12 months

• Adverse event of drugs

  12 months

Study Arms (2)

Norfloxacin

ACTIVE COMPARATOR

norfloxacin 400 mg once daily administration

Drug: Norfloxacin

Ciprofloxacin

EXPERIMENTAL

Ciprofloxacin 750 mg per week

Drug: ciprofloxacin

Interventions

Norfloxacin DRUG

Norfloxacin 400 mg per day

Norfloxacin

ciprofloxacin DRUG

Ciprofloxacin 750 mg per week

Ciprofloxacin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-75 years old
• Liver cirrhosis with ascites
• Ascitic polymorphonucleated cells (PMN) count \< 250/mm3
• Ascitic protein \<= 1.5 g/dL or History of SBP

You may not qualify if:

• Hypersensitivity or intolerability with quinolones
• Hepatocellular carcinoma beyond Milan Criteria
• Hepatic encephalopathy over stage 2
• History of treatment with antibiotics within 2 weeks of enrollment
• HIV infection
• Untreated malignancy
• Women with child-bearing age not willing to use effective contraception.
• Pregnant or breast feeding women
• Not able to give informed consents

Sponsors & Collaborators

• Korea University: lead
• Sungkyunkwan University: collaborator
• Kyungpook National University Hospital: collaborator
• Soon Chun Hyang University: collaborator

Study Sites (7)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Location

Soonchunhyang University College of Medicine, Bucheon Hospital

Bucheon-si, South Korea

Location

Soonchunhyang University College of Medicine, Cheonan Hospital

Cheonan, South Korea

Location

Kyungpuk National University Hospital

Daegu, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Soonchunhyang University College of Medicine, Seoul Hospital

Seoul, South Korea

Location

Sungkyunkwan University Gangbuk Samsung Hospital

Seoul, South Korea

Location

Related Publications (7)

• Mowat C, Stanley AJ. Review article: spontaneous bacterial peritonitis--diagnosis, treatment and prevention. Aliment Pharmacol Ther. 2001 Dec;15(12):1851-9. doi: 10.1046/j.1365-2036.2001.01116.x.

  PMID: 11736714 BACKGROUND

• Koulaouzidis A, Bhat S, Karagiannidis A, Tan WC, Linaker BD. Spontaneous bacterial peritonitis. Postgrad Med J. 2007 Jun;83(980):379-83. doi: 10.1136/pgmj.2006.056168.

  PMID: 17551068 BACKGROUND

• Fernandez J, Navasa M, Gomez J, Colmenero J, Vila J, Arroyo V, Rodes J. Bacterial infections in cirrhosis: epidemiological changes with invasive procedures and norfloxacin prophylaxis. Hepatology. 2002 Jan;35(1):140-8. doi: 10.1053/jhep.2002.30082.

  PMID: 11786970 BACKGROUND

• European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.

  PMID: 20633946 BACKGROUND

• Rolachon A, Cordier L, Bacq Y, Nousbaum JB, Franza A, Paris JC, Fratte S, Bohn B, Kitmacher P, Stahl JP, et al. Ciprofloxacin and long-term prevention of spontaneous bacterial peritonitis: results of a prospective controlled trial. Hepatology. 1995 Oct;22(4 Pt 1):1171-4. doi: 10.1016/0270-9139(95)90626-6.

  PMID: 7557868 RESULT

• Grange JD, Roulot D, Pelletier G, Pariente EA, Denis J, Ink O, Blanc P, Richardet JP, Vinel JP, Delisle F, Fischer D, Flahault A, Amiot X. Norfloxacin primary prophylaxis of bacterial infections in cirrhotic patients with ascites: a double-blind randomized trial. J Hepatol. 1998 Sep;29(3):430-6. doi: 10.1016/s0168-8278(98)80061-5.

  PMID: 9764990 RESULT

• Fernandez J, Navasa M, Planas R, Montoliu S, Monfort D, Soriano G, Vila C, Pardo A, Quintero E, Vargas V, Such J, Gines P, Arroyo V. Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis. Gastroenterology. 2007 Sep;133(3):818-24. doi: 10.1053/j.gastro.2007.06.065. Epub 2007 Jul 3.

  PMID: 17854593 RESULT

Related Links

• Korea University (PI of SBP\_prevention study is belong to this university)

MeSH Terms

Interventions

Norfloxacin; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Soon Ho Um, M.D., Ph.D.

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Hyung Joon Yim, M.D., Ph.D.

  Korea University Ansan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 26, 2012
• First Posted: March 2, 2012
• Study Start: August 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: April 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-12

Locations

KR (7)