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5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Concomitant therapy, Sequential therapy, levofloxacin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study.

Exclusion Criteria:

  • previous treatment for H. pylori infection,
  • use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study,
  • gastrointestinal malignancy,
  • previous gastro-oesophageal surgery,
  • severe concomitant cardiovascular,
  • respiratory or endocrine diseases,
  • clinically significant renal or hepatic disease,
  • hematologic disorders,
  • any other clinically significant medical condition that could increase risk,
  • history of allergy to any of the drug used in the study,
  • pregnancy or lactation,
  • alcohol abuse,
  • drug addiction,
  • severe neurologic or psychiatric disorders, and
  • long-term use of corticosteroids or anti-inflammatory drugs.

Sites / Locations

  • Dipartimento di Internistica Clinica e Sperimentale, SUN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5d-QCT

10-day sequential regimen

Arm Description

5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid

5 days of esomeprazole 40mg bid + amoxicillin 40mg bid followed by 5 more days of esomeprazole 40mg bid + levofloxacin 500mg bid + tinidazole 500 mg bid

Outcomes

Primary Outcome Measures

Eradication Rate
The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses

Secondary Outcome Measures

Adverse events
The incidence of adverse events during therapy will be assessed: bad taste, taste alteration, nausea, vomiting, diarrhoea, epigastric pain, glossitis, headache
Costs of either regimen
The costs related to each treatment will be determined

Full Information

First Posted
February 22, 2012
Last Updated
March 5, 2012
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT01544517
Brief Title
5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection
Official Title
Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.
Detailed Description
The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, Concomitant therapy, Sequential therapy, levofloxacin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5d-QCT
Arm Type
Experimental
Arm Description
5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid
Arm Title
10-day sequential regimen
Arm Type
Active Comparator
Arm Description
5 days of esomeprazole 40mg bid + amoxicillin 40mg bid followed by 5 more days of esomeprazole 40mg bid + levofloxacin 500mg bid + tinidazole 500 mg bid
Intervention Type
Drug
Intervention Name(s)
Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
Other Intervention Name(s)
proton pump inhibitors
Intervention Description
amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg
Primary Outcome Measure Information:
Title
Eradication Rate
Description
The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events
Description
The incidence of adverse events during therapy will be assessed: bad taste, taste alteration, nausea, vomiting, diarrhoea, epigastric pain, glossitis, headache
Time Frame
1 year
Title
Costs of either regimen
Description
The costs related to each treatment will be determined
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study. Exclusion Criteria: previous treatment for H. pylori infection, use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study, gastrointestinal malignancy, previous gastro-oesophageal surgery, severe concomitant cardiovascular, respiratory or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders, any other clinically significant medical condition that could increase risk, history of allergy to any of the drug used in the study, pregnancy or lactation, alcohol abuse, drug addiction, severe neurologic or psychiatric disorders, and long-term use of corticosteroids or anti-inflammatory drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Romano, MD
Organizational Affiliation
Second University of Naples Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dipartimento di Internistica Clinica e Sperimentale, SUN
City
Naples
State/Province
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

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5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection

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