Status:
RECRUITING
Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Phathom Pharmaceuticals
NRG Oncology
Conditions:
H Pylori Infection
H Pylori Gastritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 fo...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years of age
Exclusion
- 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
Key Trial Info
Start Date :
October 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 6 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07224035
Start Date
October 15 2022
End Date
November 6 2027
Last Update
November 4 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136