High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: High Dose Dual Therapy This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. |
Drug: Amoxicillin
1 g
Drug: Omeprazole
40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
|
Active Comparator: Standard triple therapy 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
1 g
Drug: Omeprazole
40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Drug: Clarithromycin
500 mg twice daily
|
Outcome Measures
Primary Outcome Measures
- Eradication rate [end of study at 6 weeks]
The eradication rate of high dose dual therapy vs clarithromycin triple therapy after treatment.
Secondary Outcome Measures
- Number of participants with protocol specific adverse events [end of study at 6 weeks]
Patient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia
- Number of participants completing at least 90% of all prescribed medications [end of study at 6 weeks]
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).
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mount Sinai Union Square Division of Digestive Diseases | New York | New York | United States | 10003 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
Investigators
- Principal Investigator: Ilan Weisberg, MD, MSc, Mount Sinai Beth Israel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY-19-01590