Sponsor study identifier
interventional
124
1 country
7
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)Study Completion
April 2016
Actual (reported)Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 26, 2012
Actual (reported)March 2, 2012
Actual (reported)July 2015
Actual (reported)April 2016
Actual (reported)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
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
norfloxacin 400 mg once daily administration
Ciprofloxacin 750 mg per week
Norfloxacin 400 mg per day
Ciprofloxacin 750 mg per week
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Soonchunhyang University College of Medicine, Bucheon Hospital
Bucheon-si, South Korea
Soonchunhyang University College of Medicine, Cheonan Hospital
Cheonan, South Korea
Kyungpuk National University Hospital
Daegu, South Korea
Korea University Anam Hospital
Seoul, South Korea
Soonchunhyang University College of Medicine, Seoul Hospital
Seoul, South Korea
Sungkyunkwan University Gangbuk Samsung Hospital
Seoul, South Korea
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.
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.
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.
Soon Ho Um, M.D., Ph.D.
Korea University Anam Hospital
Hyung Joon Yim, M.D., Ph.D.
Korea University Ansan Hospital
124 participants (actual enrollment reported by the registry).
First Submitted
February 26, 2012
First Posted
March 2, 2012
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Pharmacokinetics of Ciprofloxacin in Pediatric Patients
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
July 2015
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
December 28, 2016
Record last verified: 2016-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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