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NCT04746937 Clinical Trial

Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis

Spontaneous Bacterial Peritonitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04746937
Other study ID # NTZ in Prevention of SBP
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date March 2021
Est. completion date May 2022

Study information
Verified date February 2021
Source Tanta University
Contact eslam M. Altaras
Phone 00201010730130
Email PG_88188@pharm.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date May 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Nitazoxanide
nitazoxanide adjuvant to standard therapy
• Norfloxacin
Standard therapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Outcome
Type Measure Description Time frame Safety issue
Primary Prevention of Secondary Spontaneous Bacterial Peritonitis Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group 3 months
Secondary Change in Biological Biomarkers 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 3 months
See also
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Completed NCT02528097 - A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis N/A
Completed NCT01193426 - Diagnostic of Spontaneous Bacterial Peritonitis
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Completed NCT02608658 - Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites N/A
Completed NCT02388035 - Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis N/A
Completed NCT03163745 - Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis
Completed NCT04273373 - Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis. N/A
Active, not recruiting NCT04395365 - Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis Phase 3
Terminated NCT00570960 - Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis Phase 4
Recruiting NCT05422118 - Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis N/A