NCT04161768

Brief Summary

Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
32mo left

Started Dec 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress74%
Dec 2018Dec 2028

Study Start

First participant enrolled

December 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

10 years

First QC Date

November 10, 2019

Last Update Submit

November 10, 2019

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

  • Number of bouts of recurrence during treatment.

    The recurrence of infection during treatment.

    6 months

Study Arms (2)

Norfloxacin

ACTIVE COMPARATOR

Norfloxacin 400 mg daily

Drug: Norfloxacin

Norfloxacin and Itopride

EXPERIMENTAL

Norfloxacin 400 mg daily and Itopride 50 mg three times daily.

Drug: NorfloxacinDrug: Itopride

Interventions

NorfloxacinDRUG

Norfloxacin 400 mg daily

Also known as: Epinor
NorfloxacinNorfloxacin and Itopride
ItoprideDRUG

Itopride 50 mg three times daily

Also known as: Ganaton
Norfloxacin and Itopride

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cirrhotic patients with ascites who had previous episodes of SBP.

You may not qualify if:

  • \. Allergy or contraindication for the used drugs. 2. Recent antibiotics therapy in the previous 2 weeks. 3. Patients with hepatocellular carcinoma or other neoplasia. 4. Pregnant and lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Interventions

Norfloxacinitopride

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Afaf Younes Mohammed Younes, Msc

    Tanta University - Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Mona Ahmed Helmy Shehata, Prof.

    Tanta University - Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Sherief Abd-Elsalam, Ass. Prof.

    Tanta University - Tropical Medicine Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

sherief abd-elsalam, ass. prof.

CONTACT

00201147773440sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 13, 2019

Study Start

December 1, 2018

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)