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NCT Number: NCT01544517

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

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

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dipartimento di Internistica Clinica e Sperimentale, SUN

Naples, Napoli, 80131, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)

Drug

amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg

Other names: proton pump inhibitors

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Costs of either regimen

    Time frame: 1 year

    The costs related to each treatment will be determined

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 6, 2012
Registry last updated
Mar 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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