Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

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ClinicalTrials.gov Identifier: NCT01792700

Recruitment Status : Completed

First Posted : February 15, 2013

Last Update Posted : February 15, 2013

Sponsor:

Information provided by (Responsible Party):

Nayoung Kim, Seoul National University Bundang Hospital

Study Description

Brief Summary:

patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and culture). In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.

Condition or disease	Intervention/treatment	Phase
Helicobacter Infections	Drug: esomeprazole Drug: tripotassium dicitrate bismuthate Drug: metronidazole Drug: tetracycline Drug: moxifloxacin Drug: amoxicillin	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	648 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	January 2003
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: MEA MEA: moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.)	Drug: esomeprazole Drug: moxifloxacin Drug: amoxicillin
Active Comparator: EBMT EBMT: esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d)	Drug: esomeprazole Drug: tripotassium dicitrate bismuthate Drug: metronidazole Drug: tetracycline

Outcome Measures

Primary Outcome Measures :

Helicobacter pylori reinfection rate [ Time Frame: From date of randomization until the date of first documented reinfection of Helicobacter pylori, whichever came first, assessed up to 90 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	23 Years to 84 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients were considered persistent H. pylori infection if 13C-urea breath test (UBT) or invasive H. pylori test (Giemsa histology, CLO test, culture) were positive despite PPI-based triple therapy.

Exclusion Criteria:

Patients were excluded from the study if they had a history of renal or hepatic impairment, previous gastric surgery, pregnancy or lactation, therapy with steroids or non-steroidal anti-inflammatory drugs, or therapy with a proton pump inhibitor (PPI) or antibiotics within four weeks of entry.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792700

Locations

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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of

Sponsors and Collaborators

Seoul National University Bundang Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kim MS, Kim N, Kim SE, Jo HJ, Shin CM, Park YS, Lee DH. Long-term follow up Helicobacter Pylori reinfection rate after second-line treatment: bismuth-containing quadruple therapy versus moxifloxacin-based triple therapy. BMC Gastroenterol. 2013 Sep 19;13:138. doi: 10.1186/1471-230X-13-138.

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Responsible Party:	Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:	NCT01792700
Other Study ID Numbers:	B-0603/031-013
First Posted:	February 15, 2013 Key Record Dates
Last Update Posted:	February 15, 2013
Last Verified:	February 2013

Additional relevant MeSH terms:

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Helicobacter Infections Gram-Negative Bacterial Infections Bacterial Infections Amoxicillin Moxifloxacin Metronidazole Tetracycline Esomeprazole Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors	Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiprotozoal Agents Antiparasitic Agents Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Protein Synthesis Inhibitors

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