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

University of Campania "Luigi Vanvitelli"

Status and phase: Completed; Phase 3

Conditions: Helicobacter Pylori Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01544517

EudraCT 2010-02464415

Details and patient eligibility

About

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

Full 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

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

5d-QCT

Experimental group

Description:

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

Treatment:

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

10-day sequential regimen

Active Comparator group

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

Treatment:

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