Trial Outcomes & Findings for The Efficacy of the Tailored Therapy Based on Antimicrobial Susceptibility for 2nd Eradication of H. Pylori (NCT NCT02349685)
NCT ID: NCT02349685
Last Updated: 2016-10-04
Results Overview
the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens. The eradication rate was evaluated by intention to treat (ITT)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
219 participants
Primary outcome timeframe
6 weeks after completion of eradication
Results posted on
2016-10-04
Participant Flow
Participant milestones
| Measure |
14 Day PBMT Group
Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
14 day PBMT group: Rescue therapy using 14 day PBMT regimen \[Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d\]
|
14 Day MEA Group
PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)
|
14 Day Tailored Therapy Group
based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
|
|---|---|---|---|
|
Overall Study
STARTED
|
89
|
89
|
41
|
|
Overall Study
COMPLETED
|
84
|
87
|
37
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy of the Tailored Therapy Based on Antimicrobial Susceptibility for 2nd Eradication of H. Pylori
Baseline characteristics by cohort
| Measure |
14 Day PBMT Group
n=89 Participants
Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
14 day PBMT group: Rescue therapy using 14 day PBMT regimen \[Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d\]
|
14 Day MEA Group
n=89 Participants
PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)
|
14 Day Tailored Therapy Group
n=41 Participants
based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
|
Total
n=219 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Age, Continuous
|
55.7 years
n=5 Participants
|
59.2 years
n=7 Participants
|
54.5 years
n=5 Participants
|
54.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
89 participants
n=5 Participants
|
89 participants
n=7 Participants
|
41 participants
n=5 Participants
|
219 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after completion of eradicationthe efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens. The eradication rate was evaluated by intention to treat (ITT)
Outcome measures
| Measure |
14 Day PBMT Group
n=89 Participants
Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
14 day PBMT group: Rescue therapy using 14 day PBMT regimen \[Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d\]
|
14 Day MEA Group
n=89 Participants
PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)
|
14 Day Tailored Therapy Group
n=41 Participants
based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute.
|
|---|---|---|---|
|
Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
|
67 participants
|
63 participants
|
36 participants
|
SECONDARY outcome
Timeframe: 6 weeks after completion of eradicationthe efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens. The eradication rate was evaluated by per-protocol analysis (PP)
Outcome measures
| Measure |
14 Day PBMT Group
n=84 Participants
Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d
14 day PBMT group: Rescue therapy using 14 day PBMT regimen \[Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d\]
|
14 Day MEA Group
n=87 Participants
PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)
|
14 Day Tailored Therapy Group
n=37 Participants
based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute.
|
|---|---|---|---|
|
Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
|
67 participants
|
63 participants
|
37 participants
|
Adverse Events
14 Day PBMT Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
14 Day MEA Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
14 Day Tailored Therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER