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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01061437
• Date of registration: 01/02/2010
• Prospective Registration: No
• Primary sponsor: Southwest Oncology Group
• Public title: S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)
• Scientific title: A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori
• Date of first enrolment: June 2009
• Target sample size: 1859
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01061437
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Chile, Colombia, Costa Rica, Honduras, Mexico, Nicaragua

Contacts

• Name: E. Robert Greenberg, M.D.
• Affiliation: Southwest Oncology Group

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Helicobacter Pylori Infection

Intervention(s)

Drug: PACMx5

Drug: PACx14

Drug: PAx5/PCMx5

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

S0701

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bill and Melinda Gates Foundation