Status:
COMPLETED
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A phase 4 prospective, randomized, open-label clinical trial evaluating the efficacy of high dose dual therapy vs standard triple therapy in a diverse, urban New York City population.
Detailed Description
All patients, at least 18 years of age, with a chief complaint of dyspepsia and documented treatment-naïve HP infection diagnosed on UBT, esophagogastroduodenoscopy (EGD) with HP biopsy, or SAT were r...
Eligibility Criteria
Inclusion
- Age 18 or older
- Treatment-naïve
- Clinical diagnosis of helicobacter pylori infection based on urea breath test, endoscopy or stool antigen test
- Subject willing to participate and able to provide informed consent.
Exclusion
- Prior helicobacter pylori treatment failure
- Antibiotic exposure within the past 4 weeks of helicobacter pylori diagnosis
- Pregnancy or breastfeeding
- Penicillin allergy
- History of active or non-gastric malignancy
- Severe illness requiring hospitalization during treatment period
- Starting additional antibiotic while on treatment
Key Trial Info
Start Date :
June 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05342532
Start Date
June 12 2019
End Date
January 1 2022
Last Update
February 1 2023
Active Locations (1)
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1
Mount Sinai Union Square Division of Digestive Diseases
New York, New York, United States, 10003