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SBP - Spontaneous Bacterial PeritonitisPhase 1/2NCT07803952

N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis

A Phase 1/2 study testing NAC in people with SBP - Spontaneous Bacterial Peritonitis, run by Tanta University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
SBP - Spontaneous Bacterial Peritonitis
What is being tested?
NAC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
25 Oct 2026to 1 Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 9Show fewer
  • Previous NAC administration during the current SBP episode.
  • Inability to receive oral study medication.
  • Participation in another interventional trial that may affect study outcomes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Tanta University Hospital

    Tanta

    KHADIJA GALAL, +201118969649, khadija.ahmed@pharm.tanta.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Adjunctive N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis: A Randomized Controlled Trial

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.

Read more

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.

Being tested
Placebo, NAC

What participants receive

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

  • PlaceboDrug

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

  • NACDrug

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

Study groups in NCT07803952
Study groupRoleWhat they receive
CONTROLPlacebo comparatorNot described
Receives: Drug: Placebo
NACActive comparatorNot described
Receives: Drug: NAC

What is being measured

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

  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

    Measured: 48 H

Timeline

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

  1. First posted4 Sep 2026
  2. Study start25 Oct 2026
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07803952
Sponsor's protocol ID
N-Acetylcysteine
Status last verified
Oct 2026
First submitted
31 Aug 2026
Last updated
30 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NAC in people with SBP - Spontaneous Bacterial Peritonitis, run by Tanta University 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 0 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in ascitic-fluid polymorphonuclear (PMN) count from baseline to 48 hours after initiation of treatment (time frame: 48 H). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 Oct 2026.

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