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

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)

• Registration Number: NCT01544517
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-05
• Study Completion: 2011-12
• Status Verified: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-03-05
• Last Update Submitted: 2012-03-05
• Study First Posted: 2012-03-06
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5d-QCT	Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)	5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid
10-day sequential regimen	Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)	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

Primary Outcome Measures

Name	Time	Method
Eradication Rate	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

Name	Time	Method
Adverse events	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	1 year	The costs related to each treatment will be determined

Trial Locations

Locations (1)

Dipartimento di Internistica Clinica e Sperimentale, SUN; 🇮🇹 Naples, Napoli, Italy