- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02349685
The Efficacy of the Tailored Therapy Based on Antimicrobial Susceptibility for 2nd Eradication of H. Pylori
The Efficacy of the Culture Based Tailored Therapy for Helicobacter Pylori Eradication Comparing With the Traditional 2nd Line Rescue Therapy in Korean
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The patients who proved a failure of 1st eradication of H. pylori with Proton pump inhibitor based triple therapy (PPI bid + amoxacillin 1g b.i.d + Clarithromycin 500 mg b.i.d) or sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d) following three methods
- positive rapid urease test (CLOtest)
- histologic evidence of H. pylori by modified Giemsa staining
- positive 13C-Urea breath test
- Male and female Korean Adult (Aged ≥ 18 years)
Exclusion Criteria:
- Patients who received two or more eradication therapy for H. pylori infection
- H. pylori eradication failure because of poor compliance
- the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
- Advanced gastric cancer or other malignancy
- Abnormal liver function or liver cirrhosis
- Abnormal renal function or chronic kidney disease
- Other severe concurrent diseases
- Previous allergic reactions to the study drugs
- Pregnant or lactating women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 14 day bismuth based quadruple therapy (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
|
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]
|
Experimental: 14 day Moxifloxacin containing triple therapy (MEA) group
PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.
|
Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)
|
Active Comparator: 14 day tailored therapy group
based on H. pylori culture and antimicrobial sensitivity, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
|
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 [amoxicillin (AMC), MIC ≥ 0.5 μg / ml; clarithromycin (CLA), MIC > 1.0 μ g / ml; metronidazole (MET), MIC > 8 μ g / ml; tetracycline (TC), MIC > 4 μ g / ml; and moxifloxacin (MOX), MIC > 1 μ g / ml).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
Time Frame: 6 weeks after completion of eradication
|
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) |
6 weeks after completion of eradication
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
Time Frame: 6 weeks after completion of eradication
|
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) |
6 weeks after completion of eradication
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nayoung Kim, M.D., Ph. D, Seoul National University Bundang Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1412/280-119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Helicobacter Infection
-
Shanghai Jiao Tong University School of MedicineCompletedCure Rate of Helicobacter Pylori InfectionChina
-
Tanta UniversityNot yet recruitingPersistent Helicobacter Pylori InfectionEgypt
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingHelicobacter Pylori Infection | Helicobacter Pylori EradicationBangladesh
-
Seoul National University Bundang HospitalRecruitingHelicobacter Pylori Infection | Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation | Helicobacter Pylori Associated Gastrointestinal Disease | Helicobacter Pylori Infection, Susceptibility toKorea, Republic of
-
Iyad Naeem Muhammad, PhDCompletedHelicobacter Pylori Infection | Helicobacter Pylori Infection, Susceptibility toPakistan
-
Shandong UniversityRecruitingHelicobacter Pylori Infection | Patient Education | Helicobacter Pylori EradicationChina
-
Seoul National University Bundang HospitalRecruitingHelicobacter InfectionKorea, Republic of
-
Seoul National University Bundang HospitalTerminatedHelicobacter InfectionKorea, Republic of
-
Shandong UniversityCompletedHelicobacter Pylori Infection Helicobacter Pylori Eradication Patient EducationChina
-
National University Hospital, SingaporeUnknownHELICOBACTER PYLORI INFECTIONSSingapore
Clinical Trials on 14 day PBMT group
-
PfizerCompleted
-
Robert Jones and Agnes Hunt Orthopaedic and District...Smith & Nephew, Inc.Recruiting
-
Boehringer IngelheimCompleted
-
Amphivena Therapeutics, Inc.CompletedMyelodysplastic Syndrome (MDS)United States
-
Jiangsu Province Centers for Disease Control and...Academy of Military Medical Sciences,Academy of Military Sciences,PLA; ZHONGYIANKE... and other collaboratorsRecruiting
-
Cambridge University Hospitals NHS Foundation TrustUniversity of CambridgeNot yet recruitingInfections | Sepsis | Atrial Fibrillation | Cardiac ArrhythmiaUnited Kingdom
-
EngenderHealthUnited States Agency for International Development (USAID); World Health OrganizationCompletedVaginal FistulaKenya, Ethiopia, Congo, The Democratic Republic of the, Guinea, Nigeria, Niger, Sierra Leone, Uganda
-
University Hospital, Basel, SwitzerlandEuropean Union; Preventicus GmbHRecruitingAtrial FibrillationHungary, Germany, Greece, Netherlands, Poland, Switzerland
-
Respivert LtdCompletedAsthma | Healthy VolunteersUnited Kingdom
-
University at BuffaloCompletedArrhythmia, Palpitations, LightheadednessUnited States