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The Efficacy of the Tailored Therapy Based on Antimicrobial Susceptibility for 2nd Eradication of H. Pylori

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ClinicalTrials.gov Identifier: NCT02349685
Recruitment Status : Completed
First Posted : January 29, 2015
Results First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Helicobacter Infection
Interventions Procedure: H. pylori culture and antimicrobial susceptibility test
Drug: 14 day PBMT group
Drug: 14 day MEA group
Enrollment 219
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 14 Day PBMT Group 14 Day MEA Group 14 Day Tailored Therapy Group
Hide Arm/Group Description

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]

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.)

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.
Period Title: Overall Study
Started 89 89 41
Completed 84 87 37
Not Completed 5 2 4
Arm/Group Title 14 Day PBMT Group 14 Day MEA Group 14 Day Tailored Therapy Group Total
Hide Arm/Group Description

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]

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.)

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 of all reporting groups
Overall Number of Baseline Participants 89 89 41 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 89 participants 41 participants 219 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
49
  55.1%
52
  58.4%
27
  65.9%
128
  58.4%
>=65 years
40
  44.9%
37
  41.6%
14
  34.1%
91
  41.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 89 participants 89 participants 41 participants 219 participants
55.7
(18 to 74)
59.2
(25 to 75)
54.5
(29 to 75)
54.5
(18 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 89 participants 41 participants 219 participants
Female
43
  48.3%
53
  59.6%
25
  61.0%
121
  55.3%
Male
46
  51.7%
36
  40.4%
16
  39.0%
98
  44.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 89 participants 89 participants 41 participants 219 participants
89 89 41 219
1.Primary Outcome
Title Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
Hide Description

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)

Time Frame 6 weeks after completion of eradication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 14 Day PBMT Group 14 Day MEA Group 14 Day Tailored Therapy Group
Hide Arm/Group Description:

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]

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.)

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.

Overall Number of Participants Analyzed 89 89 41
Measure Type: Number
Unit of Measure: participants
67 63 36
2.Secondary Outcome
Title Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
Hide Description

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 per-protocol analysis (PP)

Time Frame 6 weeks after completion of eradication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 14 Day PBMT Group 14 Day MEA Group 14 Day Tailored Therapy Group
Hide Arm/Group Description:

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]

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.)

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.

Overall Number of Participants Analyzed 84 87 37
Measure Type: Number
Unit of Measure: participants
67 63 37
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 14 Day PBMT Group 14 Day MEA Group 14 Day Tailored Therapy Group
Hide Arm/Group Description

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]

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.)

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.
All-Cause Mortality
14 Day PBMT Group 14 Day MEA Group 14 Day Tailored Therapy Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
14 Day PBMT Group 14 Day MEA Group 14 Day Tailored Therapy Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/87 (0.00%)   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
14 Day PBMT Group 14 Day MEA Group 14 Day Tailored Therapy Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/87 (0.00%)   0/37 (0.00%) 
Early termination leading to small number of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nayoung Kim
Organization: SeoulNUBH
Phone: + 82-31-787-7008
EMail: nayoungkim49@empas.com
Layout table for additonal information
Responsible Party: Nayoung Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02349685     History of Changes
Other Study ID Numbers: B-1412/280-119
First Submitted: January 25, 2015
First Posted: January 29, 2015
Results First Submitted: April 26, 2016
Results First Posted: October 4, 2016
Last Update Posted: October 4, 2016