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

NCT ID: NCT01061437

Last Updated: 2012-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1859 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-07-31

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).

Conditions

Helicobacter Pylori Infection

Keywords

H. pylori

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Standard 14 day, 3-drug regimen

Group Type: ACTIVE_COMPARATOR

PACx14

Intervention Type: DRUG

Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)

Arm 2

Concomitant Therapy - 5 day, 4-drug regimen

Group Type: EXPERIMENTAL

PACMx5

Intervention Type: DRUG

Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)

Arm 3

Sequential Therapy - 10 day, 4-drug regimen

Group Type: EXPERIMENTAL

PAx5/PCMx5

Intervention Type: DRUG

Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5)

Interventions

PACx14

Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)

Intervention Type: DRUG

PACMx5

Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)

Intervention Type: DRUG

PAx5/PCMx5

Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5)

Intervention Type: DRUG

Other Intervention Names

Lansoprazole: Prevacid; Lansoprazole: Prevacid; Lansoprazole: Prevacid

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

E. Robert Greenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

Pontificia Universidad Catolica de Chile

Santiago, , Chile

Universidad del Valle

Cali, Valle del Cauca Department, Colombia

Fundacion Inciensa

San José, , Costa Rica

Hospital Occidente

Copán, , Honduras

National Institute for Public Health

Cuernavaca, Morelos, Mexico

Instituto Technologico de Sonora

Obregón, Sonora, Mexico

Centro de Investigacion en Demografia y Salud de la Iglesia Merced

León, , Nicaragua

Countries

Chile; Colombia; Costa Rica; Honduras; Mexico; Nicaragua

References

Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Pena R, Pena EM, Salazar-Martinez E, Correa P, Martinez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011 Aug 6;378(9790):507-14. doi: 10.1016/S0140-6736(11)60825-8. Epub 2011 Jul 21.

Reference Type: DERIVED

PMID: 21777974 (View on PubMed)

Morgan DR, Torres J, Sexton R, Herrero R, Salazar-Martinez E, Greenberg ER, Bravo LE, Dominguez RL, Ferreccio C, Lazcano-Ponce EC, Meza-Montenegro MM, Pena EM, Pena R, Correa P, Martinez ME, Chey WD, Valdivieso M, Anderson GL, Goodman GE, Crowley JJ, Baker LH. Risk of recurrent Helicobacter pylori infection 1 year after initial eradication therapy in 7 Latin American communities. JAMA. 2013 Feb 13;309(6):578-86. doi: 10.1001/jama.2013.311.

Reference Type: DERIVED

PMID: 23403682 (View on PubMed)

Related Links

http://www.swog.org/

Click here for more information about the study: S0701, "A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori."

Other Identifiers

S0701

Identifier Type: -

Identifier Source: org_study_id