Clarithromycin Resistant Tailored Therapy

This study has been completed.
Sponsor:
Collaborator:
Korean College of Helicobacter and Upper Gastrointestinal Research
Information provided by (Responsible Party):
Jin Il Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01453036
First received: September 29, 2011
Last updated: July 31, 2013
Last verified: July 2013

September 29, 2011
July 31, 2013
August 2011
June 2012   (final data collection date for primary outcome measure)
Helicobacter Pylori Eradication Rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.
Helicobacter pylori eradication rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01453036 on ClinicalTrials.gov Archive Site
Not Provided
Accuracy of polymerase chain reaction, Helicobacter pylori [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clarithromycin Resistant Tailored Therapy
Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance
  1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance
  2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully
  3. Material & methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peptic Ulcer
  • Helicobacter Pylori Infection
  • Procedure: 23S rRNA point mutation test of Helicobacter pylori
    mutation test group>> Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test groupConventional Conventional AOC group, Conventional AOM group >> no intervention
    Other Name: Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Korea
  • Procedure: UBT test & Gastroenterology with biopsy c silver stain
    UBT test & Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group >> intervention
  • Active Comparator: Conventional AOC group
    The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
    Intervention: Procedure: UBT test & Gastroenterology with biopsy c silver stain
  • Active Comparator: Mutation test group
    Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
    Interventions:
    • Procedure: 23S rRNA point mutation test of Helicobacter pylori
    • Procedure: UBT test & Gastroenterology with biopsy c silver stain
  • Active Comparator: Conventional AOM group
    The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
    Intervention: Procedure: UBT test & Gastroenterology with biopsy c silver stain

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
924
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 20 - 75 years old
  • Peptic ulcer (gastric ulcer, duodenal ulcer)
  • Helicobacter pylori positive

Exclusion Criteria:

  • Major comorbidities
  • Pregnancy
  • History of Helicobacter pylori eradication
  • History of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion
Both
20 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01453036
CUK
Yes
Jin Il Kim, The Catholic University of Korea
Jin Il Kim
Korean College of Helicobacter and Upper Gastrointestinal Research
Principal Investigator: Hyun Jeong Lee, fellow Yeouido St. Mary's Hospital, The Catholic University of Korea
Principal Investigator: Dae Young Cheung, professor Yeouido St. Mary's Hospital, The Catholic University of Korea
Principal Investigator: Seong Su Kim, professor The Catholic University of Korea
Principal Investigator: Byeong Ug Kim The Catholic University of Korea
Principal Investigator: Tae Ho Kim The Catholic University of Korea
Principal Investigator: Eun Jung Jeon The Catholic University of Korea
Principal Investigator: Jung Hwan Oh, Professor The Catholic University of Korea
Principal Investigator: Woo Chul Chung, professor The Catholic University of Korea
Principal Investigator: Soo Heon Park The Catholic University of Korea
Principal Investigator: Jea Kwang Kim The Catholic University of Korea
Study Chair: Jin Il Kim The Catholic University of Korea
The Catholic University of Korea
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP