Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 18 years of age
排除标准
- •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
- •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
- •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
研究组 & 干预措施
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.
干预措施: PYTEST® 14C-Urea Breath Test (Drug)
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.
干预措施: VOQUEZNA® Triple Pak® (Drug)
结局指标
主要结局
Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline
时间窗: 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.
次要结局
未报告次要终点
研究者
Shria Kumar
Assistant Professor of Clinical Medicine
University of Miami