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RecruitingNCT07803952Updated Oct 30, 2026

N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis

A Phase 1/2 interventional study of Placebo and NAC in SBP - Spontaneous Bacterial Peritonitis, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Tanta University · Phase 1/2, Interventional, and Treatment

Updated Oct 30, 2026Now RecruitingFirst site in Egypt+4 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Spontaneous bacterial peritonitis (SBP) is one of the most serious infectious complications of liver cirrhosis and ascites. It affects approximately 10-30% of hospitalized patients with decompensated cirrhosis and carries an in-hospital mortality of 20-40% despite appropriate antimicrobial therapy. SBP results from bacterial translocation across the intestinal mucosa together with cirrhosis-associated immune dysfunction, leading to impaired bacterial clearance and exaggerated systemic inflammation. Current international guidelines recommend immediate empirical antibiotic therapy together with intravenous human albumin to reduce the incidence of acute kidney injury (AKI), hepatorenal syndrome, and mortality.

Although this strategy has substantially improved outcomes, treatment failure, persistent infection, renal dysfunction, acute-on-chronic liver failure (ACLF), and early mortality remain common, indicating that currently available therapy does not adequately address all pathogenic mechanisms of SBP. Increasing evidence suggests that oxidative stress is a central contributor to the progression of bacterial infections in cirrhosis. Excessive production of reactive oxygen species aggravates hepatocellular injury, endothelial dysfunction, immune dysregulation, and renal impairment, thereby amplifying systemic inflammatory responses during SBP. Consequently, therapeutic strategies targeting oxidative stress may improve host defense while limiting organ injury.

N-acetylcysteine (NAC) is a precursor of glutathione and one of the most extensively studied antioxidant agents in clinical medicine. Besides restoring intracellular glutathione stores, NAC exerts anti-inflammatory, endothelial-protective, and immunomodulatory effects through inhibition of oxidative stress and pro-inflammatory cytokine production. On the other hand, experimental studies have further demonstrated that NAC can inhibit bacterial biofilm formation, enhance antibiotic penetration, and potentiate antimicrobial activity against several clinically important bacterial pathogens.

Despite these promising biological properties, the therapeutic role of NAC in active SBP has not been established. Previous data have primarily evaluated NAC for hepato- or renal protection in liver disease. While its potential role as an adjunctive antibacterial therapy during active SBP has not been investigated in adequately designed randomized controlled trials. Therefore, the present study will evaluate whether adjunctive NAC improves early treatment response and reduces subsequent organ dysfunction and short-term adverse outcomes.

02

Conditions studied

  • SBP - Spontaneous Bacterial Peritonitis

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03

In context

Peritonitis

167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.

This study's planned enrollment of 60 is below the median of 79 across 106 interventional studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 prior to enrollment.

Exclusion Criteria

  • Secondary bacterial or fungal peritonitis.
  • Recent abdominal surgery or requiring immediate surgical intervention.
  • Known to NAC.
  • Pregnancy or lactation.
  • Septic shock, established HRS-AKI requiring rescue therapy, or renal replacement therapy at enrollment.
  • Advanced 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    CONTROL

    Drug: Placebo

  • Active comparator
    NAC

    Drug: NAC

Interventions

  • DrugPlacebo

    Standard-of-care SBP therapy + matching placebo twice daily for 7 days.

  • DrugNAC

    Standard-of-care SBP therapy + NAC 600 mg orally twice daily for 7 days.

06

What researchers measure

Primary outcomes

  1. Percentage change in ascitic-fluid polymorphonuclear (PMN) count from baseline to 48 hours after initiation of treatment

    Primary Outcome: Percentage change in ascitic-fluid polymorphonuclear (PMN) count from baseline to 48 hours after initiation of treatment. % change = \[(48-h PMN - baseline PMN) / baseline PMN\] × 100

    Time frame: 48 H

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Oct 2026 (actual). Primary completion is estimated for Jun 2027, 7 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: start Sep 2026 → Oct 2026, primary completion Sep 2027 → Jun 2027 and completion Sep 2027 → Jun 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 4, 2026
StartActual
Oct 25, 2026was Sep 2026
Primary completionEst.
Jun 1, 2027was Sep 2027
CompletionEst.
Jun 1, 2027was Sep 2027
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 30, 2026
Sites
1 site added — first site in Egypt
Show site
  • Tanta University Hospital · Tanta, Egypt
Oct 30, 2026
Start date
Sep 10, 2026→Oct 25, 2026 (actual)
Oct 30, 2026
Primary completion
Sep 1, 2027→Jun 1, 2027
Oct 30, 2026
Study completion
Sep 1, 2027→Jun 1, 2027
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Egypt
    Show site
    • Tanta University Hospital · Tanta, Egypt
    Start date Sep 10, 2026→Oct 25, 2026 (now actual)
    Primary completion Sep 1, 2027→Jun 1, 2027
    Study completion Sep 1, 2027→Jun 1, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07803952
Lead sponsor
Tanta University
Responsible party
Khadija Ahmed Mhrose Glal (Director, Tanta University) — Principal investigator
First posted
Sep 4, 2026
Start date
Oct 25, 2026
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Oct 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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