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Ascites InfectionPhase 2NCT05621005

Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients

A Phase 2 study testing Rifaximin 550 milligram Oral Tablet [XIFAXAN] in people with Ascites Infection, run by Samar Atef Sebaweh Mohammed at 1 site in Egypt.

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

Norfloxacin is the most commonly used drug for the prophylaxis against spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis. Rifaximin, another broad spectrum antibiotic with only trivial absorption from the gut, is used for the treatment of traveler's diarrhea and prevention of hepatic… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Ascites Infection
What is being tested?
Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteEgypt
Study dates
1 Mar 2019to 1 Aug 2022
Phase
Phase 2
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Decompensated cirrhotic patients (Child B or C, ascetic patients).
  • Adult male/female aged >18 years old.
  • History or evidence of previous attack of SBP and currently clinically free from SBP.

Who cannot join

  • Recent abdominal surgery.
  • Patients with renal impairment (serum creatinine >1.5mg/dl) at baseline.
  • Patients on renal replacement therapy (RRT) at baseline.
  • Sonographic evidence of Nephropathy other than grade I nephropathy in ascetic patients
  • intraabdominal source of infection (e.g. intra-abdominal abscesses, cholecystitis or acute pancreatitis).
  • Patients with current evidence of upper Urinary tract infection.
Show all 9Show fewer
  • Other comorbidities affecting the patient survival e.g. significant cardiac disease, pulmonary disease, portal vein thrombosis, hepatocellular carcinoma or other malignancies, etc.
  • Sepsis.
  • Current or recent treatment with nephrotoxic drugs or contrast material injection.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • faculty of medicine Ain Shams university

    Cairo, 02

Other trials in Egypt

About this study

Official title: Rifaximin Prophylaxis Against Recurrence of Spontaneous Bacterial Peritonitis and Occurrence of Hepatorenal Syndrome in Decompensated Cirrhotic Egyptian Patients

Norfloxacin is the most commonly used drug for the prophylaxis against spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis. Rifaximin, another broad spectrum antibiotic with only trivial absorption from the gut, is used for the treatment of traveler's diarrhea and prevention of hepatic encephalopathy.

Read the detailed description

Prophylaxis against spontaneous bacterial peritonitis (SBP) in cirrhotic patients recovered from an episode of SBP using Norfloxacin 400 mg/day is currently established standard of care. Recently we are facing the growing challenge of standard SBP prophylaxis lacking efficacy as extended spectrum beta-lactamases and fluoro-quinolone resistant bacteria in isolates of patients on Norfloxacin.

Prophylaxis against Hepatorenal Syndrome in decompensated liver cirrhosis is limited to IV administration of Albumin in patients who develop SBP and the prevention of SBP using Norfloxacin.

this study aims to investigate the effectiveness of Rifaximin in decompensated cirrhotic patients against SBP as a secondary prophylaxis measure and Hepatorenal Syndrome.

our study was non inferiority prospective non randomized controlled trial The study enrolled patients with chronic liver disease and ascites who were monitored at outpatient clinics or who were admitted to Ain Shams University hospitals.104 patients with decompensated liver cirrhosis were enrolled in the study, The Control Group (n=52), to receive standard of care treatment \& Norfloxacin prophylaxis for the decompensated liver disease and a second Treatment Group (n=52) who will receive Rifaximin prophylaxis in addition to the original management.

Being tested
Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Keywords
Rifaximin, Norflixacin, Spontaneous bacterial peritonitis

What participants receive

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

  • Rifaximin 550 milligram Oral Tablet [XIFAXAN]Drug

    Also called xifaxan

    Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months

Study groups in NCT05621005
Study groupRoleWhat they receive
treatment group or Rifaximin groupExperimentalthey received Rifaximin 550 milligram every 12 hour
Receives: Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]
control group or Norfloxacin groupActive comparatorthey received Norfloxacin 400 milligram per day
Receives: Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]

What is being measured

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

  1. secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome

    our study was conducted to test the efficacy of Rifaximin in prevention of recurrence of SBP and occurrence of hepatorenal syndrome

    Measured: 3 months

Timeline

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

  1. First posted17 Nov 2022
  2. Study start1 Mar 2019
  3. Primary completion1 Jul 2022
  4. Study completion1 Aug 2022

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 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Study design: non inferiority prospective non randomized controlled trial Study population and setting: The study enrolled patients with chronic liver disease and ascites who were monitored at outpatient clinics or who were admitted to Ain Shams University hospitals. Sample size: 104 patients with decompensated liver cirrhosis were enrolled in the study. The Control Group (n=52), to receive standard of care treatment \& Norfloxacin prophylaxis for the decompensated liver disease and a second Treatment Group (n=52) who will receive Rifaximin prophylaxis in addition to the original management.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621005
Sponsor's protocol ID
SBP prophylaxis
Status last verified
Nov 2022
First submitted
12 Nov 2022
Last updated
21 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: individual participant data will be shared including inclusion criteria and the final statical results

Publications

  • Acevedo JG, Cramp ME. Hepatorenal syndrome: Update on diagnosis and therapy. World J Hepatol. 2017 Feb 28;9(6):293-299. doi: 10.4254/wjh.v9.i6.293.

    PubMed 28293378

  • Dong T, Aronsohn A, Gautham Reddy K, Te HS. Rifaximin Decreases the Incidence and Severity of Acute Kidney Injury and Hepatorenal Syndrome in Cirrhosis. Dig Dis Sci. 2016 Dec;61(12):3621-3626. doi: 10.1007/s10620-016-4313-0. Epub 2016 Sep 21.

    PubMed 27655104

  • Fernandez J, Tandon P, Mensa J, Garcia-Tsao G. Antibiotic prophylaxis in cirrhosis: Good and bad. Hepatology. 2016 Jun;63(6):2019-31. doi: 10.1002/hep.28330. Epub 2016 Jan 11.

    PubMed 26528864

  • Moreau R, Elkrief L, Bureau C, Perarnau JM, Thevenot T, Saliba F, Louvet A, Nahon P, Lannes A, Anty R, Hillaire S, Pasquet B, Ozenne V, Rudler M, Ollivier-Hourmand I, Robic MA, d'Alteroche L, Di Martino V, Ripault MP, Pauwels A, Grange JD, Carbonell N, Bronowicki JP, Payance A, Rautou PE, Valla D, Gault N, Lebrec D; NORFLOCIR Trial Investigators. Effects of Long-term Norfloxacin Therapy in Patients With Advanced Cirrhosis. Gastroenterology. 2018 Dec;155(6):1816-1827.e9. doi: 10.1053/j.gastro.2018.08.026. Epub 2018 Aug 23.

    PubMed 30144431

  • Soriano G, Guarner C, Teixido M, Such J, Barrios J, Enriquez J, Vilardell F. Selective intestinal decontamination prevents spontaneous bacterial peritonitis. Gastroenterology. 1991 Feb;100(2):477-81. doi: 10.1016/0016-5085(91)90219-b.

    PubMed 1985045

  • Vlachogiannakos J, Viazis N, Vasianopoulou P, Vafiadis I, Karamanolis DG, Ladas SD. Long-term administration of rifaximin improves the prognosis of patients with decompensated alcoholic cirrhosis. J Gastroenterol Hepatol. 2013 Mar;28(3):450-5. doi: 10.1111/jgh.12070.

    PubMed 23216382

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rifaximin 550 milligram Oral Tablet [XIFAXAN] in people with Ascites Infection, run by Samar Atef Sebaweh Mohammed at 1 site in Egypt.

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 3 inclusion and 9 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 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome (time frame: 3 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 NCT05621005, which also lists 6 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 21 Nov 2022.

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