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Trial record 17 of 21 for:    "Gastritis" | "Clarithromycin"

Daily Four Times or Two Times Usage of PPI and Amoxicillin for the First or Second Line H. Pylori Eradication

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ClinicalTrials.gov Identifier: NCT03802318
Recruitment Status : Enrolling by invitation
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Li-Wei Chen, Chang Gung Memorial Hospital

Brief Summary:

The hypothesis and plan of the current study are:

  1. One induction phase of high dose PPI before eradication will increase intragastric pH and induce H. pylori into an active replicative status. Active replicative status will enhance the bactericidal effect of amoxicillin. Rabeprazole (20 mg) four times per day (qid) for 3 days will be used for induction in this study.
  2. High dose PPI will provide adequate plasma concentration irrespective of the CYP2C19 genotype of the population. Here rabeprazole (20 mg) qid will be applied as high dose PPI.
  3. High frequent amoxicillin usage (500 mg, qid) will maintain plasma concentration above the MIC. Amoxicillin (500 mg) qid will be described for total 14 days.
  4. In the rescue therapy, add levofloxacin on high dose dual therapy will increase the eradication rate than single high dose dual therapy. A combination of levofloxacin and high dose dual therapy will also have a better eradication rate than the common used levofloxacin based triple therapy.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Helicobacter Gastritis Helicobacter-Associated Pyloric Ulcer Drug: Rabeprazole Not Applicable

Detailed Description:

This study aims to evaluate:

  1. the first line H. pylori eradication rate of high dose dual therapy with 14 days rabeprazole 20 mg qid, plus amoxicillin 500 mg qid (HDDT group) comparing to the clarithromycin-based triple therapy with 14 days clarithromycin 500 mg bid, amoxicillin 1000mg bid , and rabeprazole 20mg bid (CATT group).
  2. the eradication efficacy in rescue therapy of a levofloxacin-based triple therapy with 14 days levofloxacin 500 mg qd, amoxicillin 500 mg qid and rabeprazole 20 mg qid (LHDT group) comparing to the common levofloxacin-based triple therapy with 14 days levofloxacin 500 mg qd, amoxicillin 1000mg bid and rabeprazole 20 mg (LATT group).

Material and Methods Patients and study design This is a prospective, randomized, open-label trial. The patients diagnosed with H. pylori infection will be enrolled from Jan 2019 to Dec 2020 in Keelung Chang-Gung Memorial hospital. The source of subjects may include (1) community participants who obtain a positive result of urea breath test (UBT) from the checkup screening (2) hospital patients who obtain a positive result of H. pylori infection by esophagogastroduodenoscopy (EGD). Exclusion criteria include age less than 20 years, pregnancy or nursing, serious concomitant illness, malignant tumors, history of hypersensitivity to study drugs, active ulcer bleeding, previous gastric surgeries, and taking PPIs within two weeks or antibiotics within one month before study. Patients without previous H. pylori eradication therapy are invited to receive the first-line regimens, whereas patients who have previously received H. pylori eradication therapy are invited to receive rescue regimens.

Hospital patients are asked to receive five endoscopic biopsy specimens (3 from gastric antrum and 2 from body mucosa) for rapid urease test (RUT) and culture studies. The definition of H. pylori infection is a positive finding from UBT, RUT or culture.

Diagnosis for H. pylori infection RUT Three specimens from endoscopic biopsy are used for the RUT (HelicotecUT ® plus test; Strong Biotech Corporation, Taipei, Taiwan). The test result will be read one hour later. A medium color change from yellowish to pink or red is recorded as a positive finding for H. pylori.

Bacterial culture and antibiotic susceptibility test Two specimens are homogenized and streaked onto an agar plate with selective medium. The plates are incubated at 37∘C under microaerophilic conditions (5% O2, 10% CO2, 85% N2) for 3-7 days. H pylori is identified by its characteristic biotyping. The primary isolates are subcultured for antibiotic susceptibility tests as described previously [21]. The E test strips (AB Biodisk, Solna, Sweden) are used for susceptibility testing. The resistance to antibiotics is according to MIC values of >0.5, ≥1, ≥8, and >1 mg/L for amoxicillin, clarithromycin, tetracycline, and levofloxacin, respectively [21].

Subjects should complete a standardized questionnaire and recorded symptoms and daily drug consumption during the treatment period to evaluate compliance and tolerability.

All patients are asked to describe any adverse event (diarrhea, taste disturbance, nausea ⁄ vomiting, bloating, abdominal pain, constipation, headache and skin rash) during the period when they are taking eradication drugs. The incidence of side effects is checked using a standardized degree of interference with daily activities format, as follows: absent; mild-not interfering; moderate-frequently interfering, but allowing treatment to be completed; severe-requiring interruption of treatment [33].

Four weeks after treatment completion, H pylori eradication success will be determined by 13C-UBT.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison Study of Helicobacter Pylori Eradication Rates Between Daily Four Times and Daily Two Times Usage of Proton Pump Inhibitor and Amoxicillin for the First Line and the Second Line Eradication Therapy
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HDDT group
high dose PPI induction (oral rabeprazole 20mg qid) for 3 days, then 14 days combined with amoxicillin (regular dose, daily 2 g, 500mg qid) for high frequency dual therapy.
Drug: Rabeprazole
Rabeprazole daily four time (Bid) or daily four times (Qid) Amoxicillin used daily two times (1000 mg bid) or daily four times (500 mg qid) apply in the first line or the second line H pylori eradication therapy
Other Name: Amoxicillin

Placebo Comparator: CATT group
conventional triple therapy 14 days (rabeprazole 20 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid)
Drug: Rabeprazole
Rabeprazole daily four time (Bid) or daily four times (Qid) Amoxicillin used daily two times (1000 mg bid) or daily four times (500 mg qid) apply in the first line or the second line H pylori eradication therapy
Other Name: Amoxicillin

Experimental: LHDT group
high dose PPI (oral rabeprazole 20mg qid) induction for 3 days, then Rabeprazole 20 mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd for 14 days.
Drug: Rabeprazole
Rabeprazole daily four time (Bid) or daily four times (Qid) Amoxicillin used daily two times (1000 mg bid) or daily four times (500 mg qid) apply in the first line or the second line H pylori eradication therapy
Other Name: Amoxicillin

Placebo Comparator: LATT group
levofloxacin base rescue therapy 14 days (rabeprazole 20 mg bid, amoxicillin 1 g bid, levofloxacin 500 mg qd)
Drug: Rabeprazole
Rabeprazole daily four time (Bid) or daily four times (Qid) Amoxicillin used daily two times (1000 mg bid) or daily four times (500 mg qid) apply in the first line or the second line H pylori eradication therapy
Other Name: Amoxicillin




Primary Outcome Measures :
  1. H. pylori eradication rate [ Time Frame: 2~3 months ]
    Two to three months after eradication therapy, urea breath test will be performed. If the result of UBT is negative, it means successful eradication. If the result is positive, it means eradicaiton failure



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The source of subjects may include (1) community participants who obtain a positive result of urea breath test (UBT) from the checkup screening (2) hospital patients who obtain a positive result of H. pylori infection by esophagogastroduodenoscopy (EGD).

Exclusion Criteria:

  • Exclusion criteria include age less than 20 years, pregnancy or nursing, serious concomitant illness, malignant tumors, history of hypersensitivity to study drugs, active ulcer bleeding, previous gastric surgeries, and taking PPIs within two weeks or antibiotics within one month before study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802318


Locations
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Taiwan
Chang-Gung memorial hospital at Keelung
Keelung, Taiwan, 20401
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Ming-Jui Hung, PhD Chang-Gung Memorial Hospital at Keelung

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Responsible Party: Li-Wei Chen, chief, division of hepato-gastroenterology, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03802318     History of Changes
Other Study ID Numbers: 201801792A3
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Li-Wei Chen, Chang Gung Memorial Hospital:
Helicobacter pylori
Proton pump inhibitor
Amoxicillin
Urea breath test
Levofloxacin
Clarithromycin

Additional relevant MeSH terms:
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Gastritis
Clarithromycin
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Levofloxacin
Ofloxacin
Rabeprazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents