NCT04746937

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 5, 2021

Last Update Submit

February 8, 2021

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

  • Prevention of Secondary Spontaneous Bacterial Peritonitis

    Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group

    3 months

Secondary Outcomes (1)

  • Change in Biological Biomarkers

    3 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

They will receive standard therapy plus placebo

Drug: Norfloxacin

Nitazoxanide Group

ACTIVE COMPARATOR

They will receive standard therapy plus nitazoxanide

Drug: NitazoxanideDrug: Norfloxacin

Interventions

NitazoxanideDRUG

nitazoxanide adjuvant to standard therapy

Also known as: NTZ
Nitazoxanide Group
NorfloxacinDRUG

Standard therapy

Control GroupNitazoxanide Group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

nitazoxanideNorfloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sahar M. Elhagar, Professor

    Supervisor for my master degree

    STUDY DIRECTOR

Central Study Contacts

eslam M. Altaras

CONTACT

00201010730130PG_88188@pharm.tanta.edu.eg

tarek M. Mostafa, A. Professor

CONTACT

00201154594035Tarek.mostafa@pharm.tanta.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Double-Blind Placebo-Controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 10, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

May 1, 2022

Last Updated

February 10, 2021

Record last verified: 2021-02