Back to resultsNitazoxanide in Prevention of Secondary Spontaneous Peritonitis
Primary Purpose
Spontaneous Bacterial Peritonitis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nitazoxanide
Norfloxacin
Sponsored by
About this trial
This is an interventional prevention trial for Spontaneous Bacterial Peritonitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control Group
Nitazoxanide Group
Arm Description
They will receive standard therapy plus placebo
They will receive standard therapy plus nitazoxanide
Outcomes
Primary Outcome Measures
Prevention of Secondary Spontaneous Bacterial Peritonitis
Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04746937
Brief Title
Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis
Official Title
Clinical Study to Evaluate the Possible Efficacy and Safety of Nitazoxanide in Secondary Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Bacterial Peritonitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Double-Blind Placebo-Controlled study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
They will receive standard therapy plus placebo
Arm Title
Nitazoxanide Group
Arm Type
Active Comparator
Arm Description
They will receive standard therapy plus nitazoxanide
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
NTZ
Intervention Description
nitazoxanide adjuvant to standard therapy
Intervention Type
Drug
Intervention Name(s)
Norfloxacin
Intervention Description
Standard therapy
Primary Outcome Measure Information:
Title
Prevention of Secondary Spontaneous Bacterial Peritonitis
Description
Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Biological Biomarkers
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eslam M. Altaras
Phone
00201010730130
Email
PG_88188@pharm.tanta.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
tarek M. Mostafa, A. Professor
Phone
00201154594035
Email
Tarek.mostafa@pharm.tanta.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar M. Elhagar, Professor
Organizational Affiliation
Supervisor for my master degree
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis
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