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

Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens

A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)

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

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Dipartimento di Internistica Clinica e Sperimentale, SUN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: proton pump inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication Rate	The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	The incidence of adverse events during therapy will be assessed: bad taste, taste alteration, nausea, vomiting, diarrhoea, epigastric pain, glossitis, headache	1 year
Costs of either regimen	The costs related to each treatment will be determined	1 year

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Principal Investigator: Marco Romano, MD, Second University of Naples Medical School

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (Estimate): March 6, 2012

Study Record Updates

• Last Update Posted (Estimate): March 6, 2012
• Last Update Submitted That Met QC Criteria: March 5, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Sequential therapy; levofloxacin; Concomitant therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Alkylating Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Amoxicillin; Levofloxacin; Ofloxacin; Tinidazole; Esomeprazole; Proton Pump Inhibitors
• Other Study ID Numbers: EudraCT 2010-02464415