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Outcome Measures

Primary Outcomes (1)

Helicobacter pylori status one month after treatment.
Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
One month after finishing with therapy.

Secondary Outcomes (2)

Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.
One month after finishing with therapy.
Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.
One month after finishing with therapy.

Study Arms (2)

Levofloxacin-based sequential Therapy

ACTIVE COMPARATOR

1. Tablets Levofloxacin 500mg BID for the first five days 2. Tablet Amoxicillin 1 gm BID for first five days 3. Capsules Omeprazole 20 mg BID for first five days followed by 1\. Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms

Drug: Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID

Moxifloxacin-based Triple Therapy

ACTIVE COMPARATOR

1. Tablet Moxifloxacin 400 mg OD for ten days 2. Tablet Amoxicillin 1 gm BID for ten days 3. Capsule Omeprazole 20 mg BID for ten days Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance.

Drug: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID

Interventions

Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BIDDrug

The eradication rate of H. Pylori with levofloxacin-based sequential therapy

Also known as: Levofloxacin, Amoxicillin, Omeprazole, Tinidazole

Levofloxacin-based sequential Therapy

Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBIDDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry

Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID

The registry names several treatments. This does not confirm that participants received them together or that they form a single product.

View registry record

Grouped treatment entry

Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID

The registry names several treatments. This does not confirm that participants received them together or that they form a single product.

View registry record

Related Publications (4)

Rakici H, Ayaz T, Akdogan RA, Bedir R. Comparison of levofloxacin- and moxifloxacin-based triple therapies with standard treatment in eradication of Helicobacter pylori as first-line therapy. Digestion. 2014;90(4):261-4. doi: 10.1159/000369788. Epub 2014 Dec 24.

PMID: 25547786BACKGROUND

Mori H, Suzuki H. Update on quinolone-containing rescue therapies for Helicobacter pylori infection. World J Gastroenterol. 2020 Apr 21;26(15):1733-1744. doi: 10.3748/wjg.v26.i15.1733.

PMID: 32351290BACKGROUND

MeSH Terms

Interventions

BID protein, humanOmeprazoleTinidazoleLevofloxacinAmoxicillinMoxifloxacin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-Ring

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Patients were randomized into two regimens: 1. Levofloxacin 500mg BID, Amoxicillin 1 gm BID, Omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mg BID, Tinidazole 500mg BID, Omeprazole 20 mg BID, or 2. Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Associate Professor

Eradication of H. Pylori Infection With Moxifloxacin

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Levofloxacin-based sequential Therapy

Moxifloxacin-based Triple Therapy

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Levofloxacin-based sequential Therapy

Moxifloxacin-based Triple Therapy

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations