Helicobacter Pylori Infection
Conditions
Keywords
high-dose dual therapy, standard triple therapy, helicobacter pylori eradication, clarithromycin resistance
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).
Interventions
DRUGAmoxicillin
1 g
DRUGOmeprazole
40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
DRUGClarithromycin
500 mg twice daily
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant With Eradication of Disease | end of study at 6 weeks | The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. | 58 |
| 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.
Amoxicillin: 1 g
Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Clarithromycin: 500 mg twice daily | 54 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 20 |
| Overall Study | Lost to Follow-up | 10 | 15 |
Baseline characteristics
| Characteristic | High Dose Dual Therapy | Standard Triple Therapy | Total |
|---|---|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 15 | 52.7 years STANDARD_DEVIATION 14.6 | 51 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 28 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 26 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 28 Participants | 27 Participants | 55 Participants |
| Sex: Female, Male Male | 30 Participants | 27 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 54 |
| other Total, other adverse events | 5 / 58 | 20 / 54 |
| serious Total, serious adverse events | 0 / 58 | 0 / 54 |
Outcome results
Primary
Number of Participant With Eradication of Disease
The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.
Time frame: end of study at 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Dual Therapy | Number of Participant With Eradication of Disease | 37 Participants |
| Standard Triple Therapy | Number of Participant With Eradication of Disease | 42 Participants |
Secondary
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).
Time frame: end of study at 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Dual Therapy | Number of Participants Completing at Least 90% of All Prescribed Medications | 58 Participants |
| Standard Triple Therapy | Number of Participants Completing at Least 90% of All Prescribed Medications | 54 Participants |
Secondary
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
Time frame: end of study at 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose Dual Therapy | Number of Participants With Protocol Specific Adverse Events | 5 Participants |
| Standard Triple Therapy | Number of Participants With Protocol Specific Adverse Events | 20 Participants |