NCT04415983

Brief Summary

Study of Nitazoxanide (NTZ) based therapeutic regimens for Helicobacter pylori in children

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
56mo left

Started Jun 2020

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 Progress56%
Jun 2020Dec 2030

First Submitted

Initial submission to the registry

June 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

10.3 years

First QC Date

June 1, 2020

Last Update Submit

June 1, 2020

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • Number of patients with cured helicobacter infection

    Total number of patients with eradicated helicobacter infection

    6 months

Study Arms (2)

Nitazoxanide group

EXPERIMENTAL

Clarithromycin, Nitazoxanide and Proton pump inhibitor

Drug: NitazoxanideDrug: ClarithromycinDrug: Proton pump inhibitor

Traditional group

ACTIVE COMPARATOR

Clarithromycin, Metronidazole and Proton pump inhibitor

Drug: ClarithromycinDrug: MetronidazoleDrug: Proton pump inhibitor

Interventions

NitazoxanideDRUG

Nitazoxanide twice daily

Also known as: nanazoxid
Nitazoxanide group
ClarithromycinDRUG

Klacid twice daily

Also known as: Klacid
Nitazoxanide groupTraditional group
MetronidazoleDRUG

Metronidazole twice daily

Also known as: Flagyl
Traditional group
Proton pump inhibitorDRUG

Omeprazoe twice daily

Nitazoxanide groupTraditional group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Positive helicobacter infection.

You may not qualify if:

  • Previous treatment for H. Pylori.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Interventions

nitazoxanideClarithromycinMetronidazoleProton Pump Inhibitors

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Rasha Gamal, Ass. Prof.

    Pediatrics department - Tanta University

    PRINCIPAL INVESTIGATOR

  • sherief Abd-Elsalam, ass. Prof.

    Tanta University Faculty of medicine

    PRINCIPAL INVESTIGATOR

  • Abeer Salamah, Lecturer

    Pediatrics department - Kafr Elsheikh University

    STUDY DIRECTOR

  • dina shawky, lecturer

    Pediatrics department - Tanta University

    STUDY DIRECTOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

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

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 4, 2020

Study Start

June 1, 2020

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)