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Adverse Reaction to Other Drugs and MedicinesPhase 4NCT01542801

Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention

A Phase 4 study testing Norfloxacin and ciprofloxacin in people with Adverse Reaction to Other Drugs and Medicines, run by Korea University at 7 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Norfloxacin and ciprofloxacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
7 sitesSouth Korea
Study dates
Aug 2011to Apr 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Untreated malignancy
  • Women with child-bearing age not willing to use effective contraception.
  • Pregnant or breast feeding women
  • Not able to give informed consents

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do

  • Soonchunhyang University College of Medicine, Bucheon Hospital

    Bucheon-si

  • Soonchunhyang University College of Medicine, Cheonan Hospital

    Cheonan

  • Kyungpuk National University Hospital

    Daegu

  • Korea University Anam Hospital

    Seoul

  • Soonchunhyang University College of Medicine, Seoul Hospital

    Seoul

  • Sungkyunkwan University Gangbuk Samsung Hospital

    Seoul

Other trials in South Korea

About this study

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

  • 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.
Read the 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.

Being tested
Norfloxacin, ciprofloxacin
Keywords
Effect of Preventive Antibiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NorfloxacinDrug

    Norfloxacin 400 mg per day

  • ciprofloxacinDrug

    Ciprofloxacin 750 mg per week

Study groups in NCT01542801
Study groupRoleWhat they receive
NorfloxacinActive comparatornorfloxacin 400 mg once daily administration
Receives: Drug: Norfloxacin
CiprofloxacinExperimentalCiprofloxacin 750 mg per week
Receives: Drug: ciprofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (5)

  1. 1 year mortality

    liver related mortality and overall mortality will be assessed.

    Measured: 12 months ( 1 year)

  2. Incidence of infectious event other than SBP

    Bacteremia, urinary tract infection, pneumonia, and other infections will be included.

    Measured: 12 months

  3. Hepatorenal syndrome

    Diagnostic criteria of hepatorenal syndrome is defined by the latest version of Internation ascites club consensus.

    Measured: 12 months

  4. Hepatic encephalopathy

    Will follow the Western Heaven Criteria.

    Measured: 12 months

  5. Adverse event of drugs

    Any of adverse event suspected by study drugs will be recorded.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionJul 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01542801
Sponsor's protocol ID
SBP_prevention
Status last verified
Dec 2016
First submitted
26 Feb 2012
Last updated
28 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11736714

  • 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.

    PubMed 17551068

  • 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.

    PubMed 11786970

  • 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.

    PubMed 20633946

  • 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.

    PubMed 7557868

  • 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.

    PubMed 9764990

  • 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.

    PubMed 17854593

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Norfloxacin and ciprofloxacin in people with Adverse Reaction to Other Drugs and Medicines, run by Korea University at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevention rate of spontaneous bacterial peritonitis (SBP) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01542801, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.

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