Clinical trial NCT01061437: S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)
Official title: A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Keywords: H. pylori
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2010-02-03
Enrollment: 1859
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization.
timeFrame: week 6 post-randomization
Secondary outcomes:
measure: Secondary aims will examine infection rates at 1 year, safety and tolerability of these regimens,& potential differential effects among selected groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Cali
country: Colombia
facility: Universidad del Valle
state: Valle
city: San Jose
country: Costa Rica
facility: Fundacion Inciensa
city: Copan
country: Honduras
facility: Hospital Occidente
city: Cuernavaca
country: Mexico
facility: National Institute for Public Health
state: Morelos
city: Obregon
country: Mexico
facility: Instituto Technologico de Sonora
state: Sonora
city: Leon
country: Nicaragua
facility: Centro de Investigacion en Demografia y Salud de la Iglesia Merced
Study officials:
affiliation: SWOG Cancer Research Network
name: E. Robert Greenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.