Clinical trial NCT05342532: High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Official title: High-Dose Dual Therapy vs Standard Triple Therapy for Treatment-Naïve H. Pylori: A Prospective Randomized Control Trial in a Diverse Urban New York City Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: high-dose dual therapy
standard triple therapy
helicobacter pylori eradication
clarithromycin resistance
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 recruited for the study. Dyspepsia was defined as persistent or recurrent abdominal pain for at least one month. All subjects who met inclusion criteria were randomly assigned by a computerized system to one of two treatment groups: standard triple therapy (STT) or high-dose dual therapy (HDDT). After patient randomization, all potential side effects were discussed. Education regarding the importance of adherence to complete the full 14 day regimen was provided. Patients were provided an electronic prescription for the respective assigned regimen along with a medication log to self-report drug compliance. The patients were asked to record medication compliance and report any adverse events to research personnel.

After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. During this period, patients were asked to abstain from taking PPI's to avoid false negative eradication testing. At the post-treatment visit, a medication log and empty pill bottles were brought in to ascertain compliance (defined as completing at least 90% of all prescribed medications).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participant With Eradication of Disease
timeFrame: end of study at 6 weeks
Secondary outcomes:
measure: Number of Participants With Protocol Specific Adverse Events
timeFrame: end of study at 6 weeks
measure: Number of Participants Completing at Least 90% of All Prescribed Medications
timeFrame: end of study at 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Union Square Division of Digestive Diseases
state: New York
Study officials:
affiliation: Mount Sinai Beth Israel
name: Ilan Weisberg, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: