5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection - Full Text View

Purpose

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

Condition	Intervention	Phase
Helicobacter Pylori Infection	Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens

Resource links provided by NLM:

Drug Information available for: Tinidazole Amoxicillin Amoxicillin sodium Omeprazole Ofloxacin Omeprazole magnesium Levofloxacin Ofloxacin hydrochloride Esomeprazole Esomeprazole Sodium Esomeprazole magnesium Helicobacter pylori infection

U.S. FDA Resources

Further study details as provided by Second University of Naples:

Primary Outcome Measures:

Eradication Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses

Secondary Outcome Measures:

Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The costs related to each treatment will be determined

Enrollment:	180
Study Start Date:	January 2011
Study Completion Date:	December 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: proton pump inhibitors

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544517

Locations

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

Sponsors and Collaborators

Second University of Naples

Investigators

Principal Investigator:

Marco Romano, MD

Second University of Naples Medical School

More Information

No publications provided

Responsible Party:	Marco Romano, Associate Professor of Gastroenterology, Second University of Naples
ClinicalTrials.gov Identifier:	NCT01544517 History of Changes
Other Study ID Numbers:	EudraCT 2010-02464415
Study First Received:	February 22, 2012
Last Updated:	March 5, 2012
Health Authority:	Italy: National Institute of Health

Keywords provided by Second University of Naples:

Helicobacter pylori
Concomitant therapy
Sequential therapy
levofloxacin

Additional relevant MeSH terms:

Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Ofloxacin
Tinidazole
Omeprazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Alkylating Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 22, 2013