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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544517
First Posted: March 6, 2012
Last Update Posted: March 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marco Romano, Second University of Naples
  Purpose
A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.

Condition Intervention Phase
Helicobacter Pylori Infection Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens

Resource links provided by NLM:


Further study details as provided by Marco Romano, Second University of Naples:

Primary Outcome Measures:
  • Eradication Rate [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    The costs related to each treatment will be determined


Enrollment: 180
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5d-QCT
5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid
Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg
Other Name: proton pump inhibitors
Active Comparator: 10-day sequential regimen
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
Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg
Other Name: proton pump inhibitors

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
  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544517


Locations
Italy
Dipartimento di Internistica Clinica e Sperimentale, SUN
Naples, Napoli, Italy, 80131
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
Principal Investigator: Marco Romano, MD Second University of Naples Medical School
  More Information

Responsible Party: Marco Romano, Associate Professor of Gastroenterology, Second University of Naples
ClinicalTrials.gov Identifier: NCT01544517     History of Changes
Other Study ID Numbers: EudraCT 2010-02464415
First Submitted: February 22, 2012
First Posted: March 6, 2012
Last Update Posted: March 6, 2012
Last Verified: February 2012

Keywords provided by Marco Romano, Second University of Naples:
Helicobacter pylori
Concomitant therapy
Sequential therapy
levofloxacin

Additional relevant MeSH terms:
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Levofloxacin
Ofloxacin
Tinidazole
Esomeprazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Alkylating Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents