Nitazoxanide for spontaneous bacterial peritonitis in adults with cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study in adults with cirrhosis and ascites investigates the safety and potential effectiveness of nitazoxanide versus placebo for treating spontaneous bacterial peritonitis. The trial includes participants with SBP diagnosed by ascitic fluid neutrophil count and excludes those with secondary peritonitis, severe renal impairment, or septic shock, among other criteria. The design comprises Phase 1 and Phase 2 components to assess tolerability, dosing, and preliminary efficacy. Primary outcomes likely focus on infection control and safety signals, while secondary outcomes may include recurrence of SBP and overall outcomes in this high-risk population. The study is led by Tanta University with a site at Tanta University Hospital in Egypt.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Adult patients (≥18 years) with liver cirrhosis diagnosed clinically, laboratory-wise, and radiologically.
* Presence of ascites.
* Diagnosis of spontaneous bacterial peritonitis is defined as an ascitic fluid polymorphonuclear leukocyte count ≥250 cells/mm³, with or without positive culture.
* Ability to provide written informed consent. Exclusion Criteria
* Secondary bacterial peritonitis.
* Recent abdominal surgery.
* Hepatocellular carcinoma or other malignancies.
* Severe renal impairment (serum creatinine \>2 mg/dL).
* Septic shock at presentation.
* Pregnancy or lactation.
* Known hypersensitivity to Nitazoxanide

Where it's running

• Tanta University Hospital
  Tanta, Egypt Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• N-Acetylcysteine to help manage spontaneous bacterial peritonitis in adults with cirrhosis

  Aimed at adults with cirrhosis and spontaneous bacterial peritonitis to see if adding N-acetylcysteine to standard therapy helps improve outcomes.

  Recruiting Phase 1/2 Tanta University · Tanta · NCT07803952

• Is routine follow-up paracentesis needed after starting antibiotics for SBP in cirrhosis?

  We’re testing whether doing a follow-up paracentesis at 48 hours after starting antibiotics changes outcomes for people with spontaneous bacterial peritonitis due to liver cirrhosis.

  Recruiting Chonnam National University Hospital · Gwangju, Gwangju · NCT07923318

• Comparing oral Gemifloxacin and intravenous Cefotaxime for treating spontaneous bacterial peritonitis

  This study is testing whether taking Gemifloxacin by mouth works as well as getting Cefotaxime through an IV for treating people with spontaneous bacterial peritonitis.

  Recruiting Phase 3 Tanta University · Tanta · NCT04168099

• Comparing Norfloxacin with Itopride to Norfloxacin alone for preventing infections in liver disease patients

  This study tests if adding Itopride to Norfloxacin can better prevent infections in liver disease patients who have had a previous infection.

  Recruiting Phase 3 Tanta University · Tanta · NCT04161768

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.