DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention

Information source: Korea University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adverse Reaction to Other Drugs and Medicines

Intervention: Norfloxacin (Drug); ciprofloxacin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Korea University

Official(s) and/or principal investigator(s):
Soon Ho Um, M.D., Ph.D., Principal Investigator, Affiliation: Korea University Anam Hospital
Hyung Joon Yim, M.D., Ph.D., Study Director, Affiliation: Korea University

Overall contact:
Soon Ho Um, M.D., Ph.D., Phone: 82-10-3311-8102, Email: umsh@korea.ac.kr

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.

Clinical Details

Official title: Comparison of Daily Norfloxacin Versus Weekly Ciprofloxacin for the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: The prevention rate of spontaneous bacterial peritonitis (SBP)

Secondary outcome:

1 year mortality

Incidence of infectious event other than SBP

Hepatorenal syndrome

Hepatic encephalopathy

Adverse event of drugs

Detailed description: Spontaneous bacterial peritonitis (SBP) is one of the most serious complication of liver cirrhosis. The short term mortality reaches 20-30% mainly due to sepsis, hepatorenal syndrome, and liver failure. In addition, patients who suffered SBP show poor prognosis with 1 year-mortality of 50-70%. The high recurrence rate is also problematic. Therefore appropriate prevention of SBP is critically needed to improve survival as well as quality of life. Selective intestinal decontamination (SID) is eradicating gram negative bacterial in the gut lumen, and effectively prevent development of SBP. Patients with gastrointestinal hemorrhage, low ascitic protein level, high bilirubin, or history of SBP need SID. Norfloxacin 400 mg daily administration decreased the incidence of SBP to 2% compared with 17% of no prevention group's among patients with ascitic protein less than 1. 5 g/dL. Also, in high risk patients (Child-Pugh score > or = 9 points and serum bilirubin level > or = 3 mg/dL, serum creatinine level > or = 1. 2 mg/dL, blood urea nitrogen level > or = 25 mg/dL, or serum sodium level < or = 130 mEq/L), norfloxacin 400 mg/day improved 1 year-survival to 60% compared with 48% of no prevention group's. Therefore norfloxacin is now primarily recommend for the prevention of SBP in cirrhotic patients. However, norfloxacin should be administered on daily basis, so efforts to reduce cost and frequency have been made. Ciprofloxacin 750 mg weekly administration has been evaluated, and shown to be effective as 3. 6% versus 22% in prevention versus no prevention arm, respectively. Therefore, ciprofloxacin 750 mg/week is a reasonable option for prevention of SBP. However, comparison of efficacy of these two methods (norfloxacin 400 mg daily versus ciprofloxacin 750 mg weekly) has not been performed, yet. The investigators aim to compare the efficacy and safety of norfloxacin 400 mg daily and ciprofloxacin 750 mg weekly for the proper management of cirrhotic patients with ascites.

Eligibility

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Incompatibility with inclusion criteria

- 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

Locations and Contacts

Soon Ho Um, M.D., Ph.D., Phone: 82-10-3311-8102, Email: umsh@korea.ac.kr

Kyungpuk National University Hospital, Daegu, Korea, Republic of; Recruiting
Soo Young Park, M.D., Phone: 82-17-515-3619, Email: psyoung@medimail.co.kr
Soo Young Park, M.D., Principal Investigator
Won Young Tak, M.D., Sub-Investigator

Korea University Anam Hospital, Seoul, Korea, Republic of; Recruiting
Soon Ho Um, Phone: 82-10-3311-8102, Email: umsh@korea.ac.kr
Yeon Seok Seo, M.D., Ph.D., Phone: 82-70-7557-9928, Email: drseo@korea.ac.kr
Soon Ho Um, M.D., Ph.D., Principal Investigator

Sungkyunkwan University Gangbuk Samsung Hospital, Seoul, Korea, Republic of; Recruiting
Byung Ik Kim, M.D., Phone: 82-11-757-7424, Email: bik.kim@samsung.com
Byung Ik Kim, M.D., Principal Investigator

Korea University Ansan Hospital, Ansan, Gyeonggi-do, Korea, Republic of; Recruiting
Hyung Joon Yim, M.D., Ph.D.
Hyung Joon Yim, M.D., Ph.D., Principal Investigator

Additional Information

Liver cirrhosis clinical research center (PI of SBP_prevention study is belong to this center)

Korea University (PI of SBP_prevention study is belong to this university)

Related publications:

Mowat C, Stanley AJ. Review article: spontaneous bacterial peritonitis--diagnosis, treatment and prevention. Aliment Pharmacol Ther. 2001 Dec;15(12):1851-9. Review.

Koulaouzidis A, Bhat S, Karagiannidis A, Tan WC, Linaker BD. Spontaneous bacterial peritonitis. Postgrad Med J. 2007 Jun;83(980):379-83. Review.

Fernández J, Navasa M, Gómez J, Colmenero J, Vila J, Arroyo V, Rodés J. Bacterial infections in cirrhosis: epidemiological changes with invasive procedures and norfloxacin prophylaxis. Hepatology. 2002 Jan;35(1):140-8.

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. Review.

Starting date: August 2011
Last updated: April 8, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017