S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: PACx14; Drug: PACMx5; Drug: PAx5/PCMx5

• Registration Number: NCT01061437
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).

Detailed Description

Prevention of gastric cancer through eradication of H. pylori is one of the most promising strategies to reduce the global impact of cancer in the near term. Our long-term goal is to prevent gastric cancer by developing and validating an effective, simple, and low-cost approach to eradication of H. pylori. Our immediate goal, therefore, is to conduct a randomized study to compare the effectiveness of three different drug regimens for H. pylori infection. The three study arms are: Standard therapy - 14 day, 3-drug regimen of Lansoprazole, amoxicillin and clarithromycin (PACx14); Concomitant therapy - 5 day, 4-drug regimen of lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential therapy - 10 day, 4-drug regimen of lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5).

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1859

Inclusion Criteria

• positive Urea Breath Test documenting H. pylori infection
• age 21 - 65 years
• no known allergies to study drugs
• only member of household participating in study
• no known medical conditions (other than H. pylori) that would preclude or require antibiotic therapy
• patients must be willing to discontinue alcohol use for 15 days (maximum duration of treatment plus one day)
• patients must be willing to discontinue use of antacids for duration of study treatment
• patients must not have used proton pump inhibitors (PPI) within 30 days of registration. Patients also must be willing to stop using non-study provided PPIs until the completion of the 6 week follow-up contact.
• patients must not have been treated with antibiotics for H. pylori in the past and must not have taken any other antibiotics within 30 days of registration.
• patients must be willing to return for 2 follow-up visits: 6 weeks after randomization following completion of treatment & 1 year after randomization
• patients must be willing to allow submission of blood for assays of serum markers of bacterial virulence and host genetic susceptibility and environmental factors and provide consent for use of specimens.

Exclusion Criteria

• current use of anti-retroviral therapy for HIV or AIDS
• diagnosed congestive hear failure
• renal failure requiring dialysis
• diagnosed hepatic failure resulting in hyperbilirubinemia
• any current or prior malignancy except: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient has been disease free for 5 years
• pregnancy or nursing mothers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	PACx14	Standard 14 day, 3-drug regimen
Arm 2	PACMx5	Concomitant Therapy - 5 day, 4-drug regimen
Arm 3	PAx5/PCMx5	Sequential Therapy - 10 day, 4-drug regimen

Primary Outcome Measures

Name	Time	Method
To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization.	week 6 post-randomization

Secondary Outcome Measures

Name	Time	Method
Secondary aims will examine infection rates at 1 year, safety and tolerability of these regimens,& potential differential effects among selected groups.	1 year

Trial Locations

Locations (7)

Universidad del Valle; 🇨🇴 Cali, Valle, Colombia

Fundacion Inciensa; 🇨🇷 San Jose, Costa Rica

Instituto Technologico de Sonora; 🇲🇽 Obregon, Sonora, Mexico

National Institute for Public Health; 🇲🇽 Cuernavaca, Morelos, Mexico

Hospital Occidente; 🇭🇳 Copan, Honduras

Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago, Chile

Centro de Investigacion en Demografia y Salud de la Iglesia Merced; 🇳🇮 Leon, Nicaragua