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

Information source: Second University of Naples
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Helicobacter Pylori Infection

Intervention: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Second University of Naples

Official(s) and/or principal investigator(s):
Marco Romano, MD, Principal Investigator, Affiliation: Second University of Naples Medical School

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Eradication Rate

Secondary outcome:

Adverse events

Costs of either regimen

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

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

Starting date: January 2011
Last updated: March 5, 2012

Page last updated: August 23, 2015

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