Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis

NCT ID: NCT04746937

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Spontaneous Bacterial Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Double-Blind Placebo-Controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Group

They will receive standard therapy plus placebo

Group Type PLACEBO_COMPARATOR

Norfloxacin

Intervention Type DRUG

Standard therapy

Nitazoxanide Group

They will receive standard therapy plus nitazoxanide

Group Type ACTIVE_COMPARATOR

Nitazoxanide

Intervention Type DRUG

nitazoxanide adjuvant to standard therapy

Norfloxacin

Intervention Type DRUG

Standard therapy

Interventions

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Nitazoxanide

nitazoxanide adjuvant to standard therapy

Intervention Type DRUG

Norfloxacin

Standard therapy

Intervention Type DRUG

Other Intervention Names

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NTZ

Eligibility Criteria

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Inclusion Criteria

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

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Eslam Mostafa Elasawy AlTaras

Clinical Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sahar M. Elhagar, Professor

Role: STUDY_DIRECTOR

Supervisor for my master degree

Central Contacts

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eslam M. Altaras

Role: CONTACT

00201010730130

tarek M. Mostafa, A. Professor

Role: CONTACT

00201154594035

Other Identifiers

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NTZ in Prevention of SBP

Identifier Type: -

Identifier Source: org_study_id

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