Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Proton pump inhibitor, Eradication
Brief summary
Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth salts are not available. The investigators compare the efficacies of 10-day levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients after failure of standard triple therapy and to determine what clinical and bacterial factors influencing the efficacy of salvage regimens.
Detailed description
In this randomized-controlled trial , the investigator recruited participants with H pylori infection after failure of first line standard triple therapy. Using a computer-generated randomization sequence, the investigators randomly allocated patients to either 10-day levofloxacin-containing sequential (EALM, esomeprazole 40 mg b.d., amoxicillin 1 g b.d.for 5 days and followed by esomeprazole 40 mg b.d., levofloxacin 500 mg qd and metronidazole for 5 days) or 10-day levofloxacin-containing triple therapy (EAL, esomeprazole 40 mg b.d., amoxicillin 1 g b.d., and levofloxacin 500 mg qd) at a 1:1 ratio. The primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.
Interventions
DRUGNexium
Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
DRUGAmolin
Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
DRUGCravit
Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm
DRUGFlagyl
Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive H. pylori-infected participants, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis who failed first-line eradication therapies with standard triple regimens (PPI twice daily, 500 mg of clarithromycin twice daily and 1 g of amoxicillin twice daily)
Exclusion criteria
* Ingestion of antibiotics, bismuth, or proton-pump inhibitors within the prior 4 weeks * Use of non-steroidal anti-inflammatory drugs within the prior 4 weeks * Participants with allergic history to the medications used * Participants with previous gastric surgery * The coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Successful Eradication of H. Pylori | Negative results of H.pylori 4 weeks after eradication | Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks. |
Participant flow
Recruitment details
164 patients who had failed the H pylori eradication attempts using the standard triple therapy (proton pump inhibitor bid, clarithromycin 500 mg bid, amoxicillin 1 g bid × 7 days) were randomly assigned to either an sequential therapy group (EALM)(n = 82) or a 10-day levofloxacin-containing teriple therapy group (EAL)(n = 82).
Pre-assignment details
We excluded those patients who had taken antibiotics, bismuth, proton-pump inhibitors, or non-steroidal anti-inflammatory drugs within the previous 4 weeks, were allergic to the medications used, had a history of previous gastric surgery or serious concomitant illness, or were currently pregnant.
Participants by arm
| Arm | Count |
|---|---|
| Sequential Therapy Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days
Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm
Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm | 82 |
| Triple Therapy Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days
Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm | 82 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Sequential Therapy | Triple Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 14 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 68 Participants | 138 Participants |
| Gender Female | 46 Participants | 42 Participants | 88 Participants |
| Gender Male | 36 Participants | 40 Participants | 76 Participants |
| Region of Enrollment Taiwan | 82 participants | 82 participants | 164 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 81 | 9 / 81 |
| serious Total, serious adverse events | 0 / 81 | 0 / 81 |
Outcome results
Primary
Percentage of Participants With Successful Eradication of H. Pylori
Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks.
Time frame: Negative results of H.pylori 4 weeks after eradication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sequential Therapy | Percentage of Participants With Successful Eradication of H. Pylori | 91.4 percentage of eradication |
| Triple Therapy | Percentage of Participants With Successful Eradication of H. Pylori | 81.5 percentage of eradication |