Trial Outcomes & Findings for Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection (NCT NCT02978157)
NCT ID: NCT02978157
Last Updated: 2019-03-14
Results Overview
Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
six weeks after the end of anti-H pylori therapy.
Results posted on
2019-03-14
Participant Flow
1. recruitment period: February 2015 2. Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital
None were excluded following participant enrollment.
Participant milestones
| Measure |
Esomeprazole+Amox+Levo
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.
|
Esomeprazole+Bismuth+Tetra+Levo
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
|
Overall Study
COMPLETED
|
52
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection
Baseline characteristics by cohort
| Measure |
Esomeprazole+Amox+Levo
n=52 Participants
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.
|
Esomeprazole+Bismuth+Tetra+Levo
n=50 Participants
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
55.08 years
STANDARD_DEVIATION 13.55 • n=5 Participants
|
56.38 years
STANDARD_DEVIATION 12.81 • n=7 Participants
|
55.72 years
STANDARD_DEVIATION 13.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
history of smoking
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: six weeks after the end of anti-H pylori therapy.Population: Intention to treat
Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication
Outcome measures
| Measure |
Esomeprazole+Amox+Levo
n=52 Participants
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.
|
Esomeprazole+Bismuth+Tetra+Levo
n=50 Participants
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
|
|---|---|---|
|
Number of Participants in Which H. Pylori Was Eradicated
|
36 participants
|
49 participants
|
Adverse Events
Esomeprazole+Amox+Levo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Esomeprazole+Bismuth+Tetra+Levo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Esomeprazole+Amox+Levo
n=52 participants at risk
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.
|
Esomeprazole+Bismuth+Tetra+Levo
n=50 participants at risk
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
4/52 • Number of events 4 • 2 months
|
16.0%
8/50 • Number of events 8 • 2 months
|
|
Gastrointestinal disorders
Dizziness
|
3.8%
2/52 • Number of events 2 • 2 months
|
6.0%
3/50 • Number of events 3 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place