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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
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