Trial Outcomes & Findings for Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication (NCT NCT02596620)
NCT ID: NCT02596620
Last Updated: 2017-02-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
Negative results of H.pylori 4 weeks after eradication
Results posted on
2017-02-28
Participant Flow
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).
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.
Participant milestones
| Measure |
Sequential Therapy
esomeprazole 40 mg bid and amoxicillin 1 g bid for 5 days, followed by esomeprazole 40 mg bid, levofloxacin 500 mg qd, and metronidazole 500 mg tid, for 5 days
|
Triple Therapy
levofloxacin 500 mg qd, amoxicillin 1 g bid, and esomeprazole 40 mg bid
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
|
Overall Study
COMPLETED
|
81
|
81
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Sequential Therapy
esomeprazole 40 mg bid and amoxicillin 1 g bid for 5 days, followed by esomeprazole 40 mg bid, levofloxacin 500 mg qd, and metronidazole 500 mg tid, for 5 days
|
Triple Therapy
levofloxacin 500 mg qd, amoxicillin 1 g bid, and esomeprazole 40 mg bid
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication
Baseline characteristics by cohort
| Measure |
Sequential Therapy
n=82 Participants
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
|
Triple Therapy
n=82 Participants
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
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
138 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Gender
Female
|
46 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Gender
Male
|
36 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
82 participants
n=93 Participants
|
82 participants
n=4 Participants
|
164 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Negative results of H.pylori 4 weeks after eradicationSuccessful 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.
Outcome measures
| Measure |
Sequential Therapy
n=81 Participants
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
|
Triple Therapy
n=81 Participants
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
|
|---|---|---|
|
Percentage of Participants With Successful Eradication of H. Pylori
|
91.4 percentage of eradication
Interval 85.1 to 97.6
|
81.5 percentage of eradication
Interval 72.8 to 90.1
|
Adverse Events
Sequential Therapy
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Triple Therapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sequential Therapy
n=81 participants at risk
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
|
Triple Therapy
n=81 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
5/81 • Number of events 5 • 2 years
|
2.5%
2/81 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
2/81 • Number of events 2 • 2 years
|
1.2%
1/81 • Number of events 1 • 2 years
|
|
General disorders
Dizziness
|
4.9%
4/81 • Number of events 4 • 2 years
|
1.2%
1/81 • Number of events 1 • 2 years
|
|
General disorders
Headache
|
3.7%
3/81 • Number of events 3 • 2 years
|
1.2%
1/81 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea/vomiting
|
8.6%
7/81 • Number of events 7 • 2 years
|
4.9%
4/81 • Number of events 4 • 2 years
|
|
General disorders
Other
|
2.5%
2/81 • Number of events 2 • 2 years
|
1.2%
1/81 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place