High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Amoxicillin
* Drug: Omeprazole
* Drug: Clarithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Dose Dual Therapy<br>This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. | Drug: Amoxicillin<br>* 1 g<br>Drug: Omeprazole<br>* 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.<br>|
| Active Comparator: Standard triple therapy<br>This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily. | Drug: Amoxicillin<br>* 1 g<br>Drug: Omeprazole<br>* 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.<br>Drug: Clarithromycin<br>* 500 mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participant With Eradication of Disease | The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment. | end of study at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Protocol Specific Adverse Events | Patient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia | end of study at 6 weeks | 
| Number of Participants Completing at Least 90% of All Prescribed Medications | Patients were provided a medication log to self-report drug compliance. After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. 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). | end of study at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high-dose dual therapy, standard triple therapy, helicobacter pylori eradication, clarithromycin resistance