Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Helicobacter Pylori Screening and Treatment
Participants in this single-arm study will undergo screening for Helicobacter pylori (H. pylori) using the PYtest® 14C-Urea Capsule Breath Test. This FDA-approved, non-invasive diagnostic method involves swallowing a radiolabeled urea capsule. If gastric urease from H. pylori is present, the urea is hydrolyzed to produce carbon dioxide and ammonia. Ten minutes after ingestion, a breath sample is collected in a balloon and transferred into a collection fluid to trap the labeled carbon dioxide. The sample is analyzed using a liquid scintillation counter to determine infection status. Participants who test positive will receive VOQUEZNA® Triple Pak® therapy, dispensed by the study team at the time of diagnosis. Phathom Pharmaceuticals will supply the medications (which include complete medication package insert), but the study team hold and dispenses medications. |
FDA-approved radiolabeled urea capsule used in the PYtest® 14C-Urea Breath Test for non-invasive detection of H. pylori.
Participants ingest the capsule, and breath samples are collected and analyzed to determine infection status.
FDA-approved combination therapy for H. pylori infection, consisting of: Vonoprazan tablets 20 mg (1 tablet twice daily for 14 days) Amoxicillin 500 mg (2 tablets twice daily for 14 days) Clarithromycin 500 mg (1 tablet twice daily for 14 days) Medications are dispensed by the study team at the time of diagnosis. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline
Time Frame: Baseline
|
This measure determines the percent of participants who test positive for Helicobacter pylori at baseline.
This is done using the PYTEST® 14C-Urea Breath Test.
Participants will receive a diagnosis on-site, approximately 30 minutes after administration of urea capsule.
This will allow immediate treatment free of charge (VOQUEZNA® Triple Pak®) initiation for positive eligible participants.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shria Kumar, MD, University of Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20211207-AIM 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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