Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1

Sponsor: University of Miami

Sponsor score: 40

ClinicalTrials ID:NCT07224035

This study screens adults aged 18 and over for H. pylori using the PYTEST® 14C-Urea Breath Test. Those testing positive receive the VOQUEZNA® Triple Pak®, a 14-day FDA-approved treatment combining vonoprazan, amoxicillin, and clarithromycin, aiming to prevent gastritis, peptic ulcers, and gastric cancer.

Patient Parameters

Program Overview

H. pylori is an infection of the stomach that can cause chronic gastritis, gastric cancer and peptic ulcer disease. The goal of this study is to screen people for this infection and offer treatment for those who test positive for the infection. By treating those who are positive for H. pylori, there is an opportunity to prevent gastritis, peptic ulcer disease, and even gastric cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults ≥ 18 years of age

Exclusion Criteria

  • Adults with a personal history of gastric cancer
  • Adults with prior history of H. Pylori (HP) treatment and confirmed eradication
  • Adults unable to consent
  • Adults unable to consent in their preferred language
  • Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed
  • Prisoners
  • Persons who are allergic, hypersensitive, or unable to take any of the components of the medication regimen VOQUEZNA® Triple Pak®:
  • vonoprazan
  • amoxicillin or any other beta-lactams (e.g. penicillins and cephalosporins)
  • clarithromycin or any other macrolide antimicrobial (e.g. erythromycin)
  • Persons presently taking any of the following:
  • Rilpivirine-containing products
  • Pimozide
  • Lomitapide, lovastatin, simvastatin, atorvastatin, and pravastatin
  • Ergot alkaloids
  • Colchicine (if with kidney or liver impairment)
  • Lurasidone
  • Drugs known to prolong the QT interval (e.g., pimozide).
  • Class IA (e.g., quinidine, procainamide, disopyramide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Verapamil, amlodipine, diltiazem, nifedipine
  • Nateglinide, pioglitazone, repaglinide, rosiglitazone, and insulin
  • Quetiapine
  • Warfarin
  • Benzodiazepines (e.g. triazolam, midazolam)
  • Persons who have any of the following, as they may be prone to adverse effects from the medication regimen:
  • History of cholestatic jaundice
  • Severe kidney impairment
  • Severe hepatic impairment
  • Participants with known prolongation of QT interval, ventricular cardiac arrhythmia, including torsades de pointes.
  • Participants with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
  • Participants with ongoing mononucleosis

Locations

FACILITYZIPCITYSTATE
University of Miami33136MiamiFlorida

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