Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis

Clinical Study to Evaluate the Possible Efficacy and Safety of Nitazoxanide in Secondary Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04746937

Enrollment

Registered

2021-02-10

Start date

2021-03-31

Completion date

2022-05-31

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Bacterial Peritonitis

Brief summary

the study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Detailed description

due to high recurrence rate of spontaneous bacterial peritonitis , we will study and evaluate the possible efficacy and safety of NTZ as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Interventions

DRUGNitazoxanide

nitazoxanide adjuvant to standard therapy

DRUGNorfloxacin

Standard therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Randomized Double-Blind Placebo-Controlled study

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients aged 21 - 65 years old with cirrhosis and ascites who had at least one previous confirmed episode of spontaneous bacterial peritonitis.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Prevention of Secondary Spontaneous Bacterial Peritonitis	3 months	Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group

Secondary

Measure	Time frame	Description
Change in Biological Biomarkers	3 months	Measurement of Tumor necrosis factor alfa , Procalcitonin(PCT), C-Reactive protein(CRP) and Erythrocyte sedimentation rate(ESR) with further calculation of PEC index \[PEC index = PCT × (ESR + CRP)\] before and after trial period

Contacts

Primary Contacteslam M. Altaras

PG_88188@pharm.tanta.edu.eg00201010730130

Backup Contacttarek M. Mostafa, A. Professor

Tarek.mostafa@pharm.tanta.edu.eg00201154594035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026