Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis

Phase 3

• Conditions: Spontaneous Bacterial Peritonitis
• Interventions: Drug: Nitazoxanide; Drug: Norfloxacin

• Registration Number: NCT04746937
• Lead Sponsor: Tanta University

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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Study First Posted: 2021-02-10
• Last Update Posted: 2021-02-10
• Study Start: 2021-03
• Primary Completion: 2022-03
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Exclusion criteria included active gastrointestinal bleeding Hepatic encephalopathy (>grade 2) Hepatocellular carcinoma (HCC) or other malignancies Allergy to used medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitazoxanide Group	Nitazoxanide	They will receive standard therapy plus nitazoxanide
Nitazoxanide Group	Norfloxacin	They will receive standard therapy plus nitazoxanide
Control Group	Norfloxacin	They will receive standard therapy plus placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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