- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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]
|
실험적: 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.)
|
활성 비교기: 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).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants in Each Arm/Group With Successful H. Pylori Eradication
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Nayoung Kim, M.D., Ph. D, Seoul National University Bundang Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- B-1412/280-119
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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-
Shin Kong Wu Ho-Su Memorial Hospital알려지지 않은
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Shanghai Changzheng Hospital아직 모집하지 않음Helicobacter Pylori의 박멸률
-
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Chuncheon Sacred Heart Hospital완전한Helicobacter Pylori와 관련된 위궤양대한민국
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University Medical Centre Ljubljana알려지지 않은
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Shanghai Jiao Tong University School of Medicine완전한
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Seoul National University Hospital알려지지 않은헬리코박터 파일로리 감염 | Helicobacter Pylori 23S rRNA Clarithromycin 내성 돌연변이대한민국
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The First Affiliated Hospital of Nanchang University알려지지 않은헬리코박터 파이로리(H. Pylori)로 인한 세균 감염 | Helicobacter Pylori의 박멸 요법 | 헬리코박터 파이로리 검출중국
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Nanjing First Hospital, Nanjing Medical University완전한헬리코박터 파일로리 감염 | Helicobacter Pylori gyrA 레보플록사신 내성 돌연변이 | 대변 약물 내성 유전자 검출 | 헬리코박터 파일로리 감염, 감수성중국
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Eisai Co., Ltd.완전한
14 day PBMT group에 대한 임상 시험
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The Faculty Hospital Na Bulovce완전한