Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Concomitant Versus Hybrid Regimen for H. Pylori Eradication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03592069
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
Hellenic Society of Gastroenterology
Information provided by (Responsible Party):
SPYRIDON MICHOPOULOS, Alexandra Hospital, Athens, Greece

Brief Summary:
10 day concomitant versus 14 day hybrid regimen as first line H. pylori eradication treatment in a high clarithromycin resistance area. A multicenter, randomized, equivalence trial.

Condition or disease Intervention/treatment Phase
H. Pylori Infection, Gastritis, Resistance and Treatment Drug: 10 day concomitant regimen Drug: 14 day hybrid regimen Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 10 Day Concomitant Versus 14 Day Hybrid Regimen as First Line H. Pylori Eradication Treatment in a High Clarithromycin Resistance Area. A Multicenter Randomized Equivalence Trial
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : July 21, 2019
Estimated Study Completion Date : July 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 10 day concomitant

After the confirmation of H. pylori infection, eligible patients randomly assigned to either concomitant or hybrid treatment group will receive:

- Concomitant for 10 days, including 40 mg of esomeprazole bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid.

Drug: 10 day concomitant regimen
10 Day Concomitant Hp therapy Concomitant for 10 days, including 40 mg of esomeprazole bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid
Other Names:
  • Amoxicillin 1gr bid from day 1 to day 10
  • Clarithromycin 500mg bid from day 1 to day 10
  • Metronidazole 500mg bid from day 1 to day 10
  • Esomeprazole 40mg bid from day 1 to day 10

Active Comparator: 14 day hybrid

After the confirmation of H. pylori infection, eligible patients randomly assigned to either concomitant or hybrid treatment group will receive:

Hybrid for 14 days, including 40 mg of esomeprazole bid and amoxicillin 1g bid, for the first 7 days followed by esomeprazole 40mg bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid, for another 7 days.

Drug: 14 day hybrid regimen
14 Day Hybrid Hp therapy Hybrid for 14 days, including 40 mg of esomeprazole bid and amoxicillin 1g bid, for the first 7 days followed by esomeprazole 40mg bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid, for another 7 days.
Other Names:
  • Amoxicillin 1gr bid from day 1 to day to day 14
  • Clarithromycin 500mg bid from day 8 to day 14
  • Metronidazole 500mg bid from day 8 to day 14
  • Esomeprazole 40mg bidfrom day 1 to day to day 14




Primary Outcome Measures :
  1. To compare eradication rates between a 10 day concomitant and a 14 day hybrid regimens in intention to treat and per protocol analyses [ Time Frame: 2 YEARS ]

Secondary Outcome Measures :
  1. Adverse events during treatment [ Time Frame: 2 YEARS ]
    The percentage of patients reporting side effects during treatment and the following days until the evaluation of Hp eradication



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • patients of 18 years or older referring for upper GI endoscopy
  • infected with H. pylori (verified with 2 out of 3 tests - rapid urease test, histology, culture)
  • without previous H. pylori eradication treatment (naïve)

Exclusion criteria are:

  • age below 18 years
  • presence of severe co-morbidities (i.e. liver cirrhosis, renal failure, haematological, neurological, psychiatric, cardiovascular or pulmonary disease)
  • previous gastric surgery
  • gastric malignancies
  • Zollinger-Elisson syndrome
  • known allergy or other contraindications to the study medications
  • previous H. pylori treatment
  • use of antibiotics , bismuth salts , NSAIDS or aspirin in the preceding month
  • use of PPI in the preceding two weeks
  • not willing to participate in the study
  • pregnant or lactating women

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): NCT03592069


Contacts
Layout table for location contacts
Contact: SPYRIDON MICHOPOULOS, DIRECTOR +302103381387 michosp5@gmail.com
Contact: SOTIRIOS GEORGOPOULOS, MD+ +302104115375 georgpap@ath.forthnet.gr

Locations
Layout table for location information
Greece
Alexandra General Hospital Recruiting
Athens, Greece, 11528
Contact: SPYRIDON MICHOPOULOS, DIRECTOR    +302103381387    michosp5@gmail.com   
Sponsors and Collaborators
Alexandra Hospital, Athens, Greece
Hellenic Society of Gastroenterology

Publications:
Layout table for additonal information
Responsible Party: SPYRIDON MICHOPOULOS, Head of GI Department, PhD, MD, Alexandra Hospital, Athens, Greece
ClinicalTrials.gov Identifier: NCT03592069     History of Changes
Other Study ID Numbers: AlexandraH
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Metronidazole
Clarithromycin
Esomeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors