N-Acetylcysteine to help manage 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 early- to mid-phase trial tests whether N-acetylcysteine, given alongside standard care for SBP, improves patient outcomes in cirrhosis. Participants must have SBP confirmed by ascitic fluid analysis and be able to take oral medication; those with severe comorbidities or requiring immediate surgery are excluded. The study compares NAC to placebo to see if it reduces kidney complications, persistent infection, and early mortality. Conducted at Tanta University Hospital, the trial spans phase 1 and phase 2, focusing on safety and preliminary efficacy in this specific population.

Why it matters

Who can join: the full rules

Inclusion Criteria: Adult patients (≥18 years) with liver cirrhosis, confirmed by clinical, radiological, or histopathological findings, who are newly diagnosed with SBP based on an ascitic fluid polymorphonuclear (PMN) leukocyte count ≥250 cells/mm³ according to the American Association for the Study of Liver Diseases (AASLD) criteria (2). Eligible participants were required to have undergone diagnostic paracentesis for ascitic fluid analysis and to provide informed consent prior to enrollment.

Exclusion Criteria

* Secondary bacterial or fungal peritonitis.
* Recent abdominal surgery or requiring immediate surgical intervention.
* Known hypersensitivity to NAC.
* Pregnancy or lactation.
* Septic shock, established HRS-AKI requiring rescue therapy, or renal replacement therapy at enrollment.
* Advanced malignancy or terminal illness.
* Previous NAC administration during the current SBP episode.
* Inability to receive oral study medication.
* Participation in another interventional trial that may affect study outcomes.

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.

• Nitazoxanide for spontaneous bacterial peritonitis in adults with cirrhosis

  This study tests whether nitazoxanide can help adults with cirrhosis and spontaneous bacterial peritonitis when compared to placebo.

  Recruiting Phase 1/2 Tanta University · Tanta · NCT07808450

• 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.