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Quadruple Therapy for Triple Therapy Resistant H. Pylori Infection (QT-Hp)

This study is currently recruiting participants.
Verified by Aga Khan University, August 2007

Sponsored by: Aga Khan University
Information provided by: Aga Khan University
ClinicalTrials.gov Identifier: NCT00520949
  Purpose

Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 7-14 days.


Condition Intervention
Treatment of Helicobacter Pylori
Drug: Quadruple therapy

ChemIDplus related topics:   Amoxicillin    Amoxicillin sodium    Amoxicillin trihydrate    Esomeprazole magnesium    Esomeprazole Sodium    Omeprazole    Omeprazole magnesium    Amoxicillin-potassium clavulanate combination    Clavulanic acid    Bismuth citrate    Bismuth   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Eradication of H. pylori infection resistant to triple therapy. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Safety of the quadruple therapy [ Time Frame: 6 weeks ]

Estimated Enrollment:   48
Study Start Date:   October 2006
Estimated Study Completion Date:   December 2007

Intervention Details:
    Drug: Quadruple therapy
    Amoxicillin-clavulanic acid 1gram b.i.d; furazolidone 200mg b.i.d; colloidal bismuth subcitrate 240mg b.i.d;esomeprazole 40mg b.i.d for 14 days.
  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Informed consent given by the patient
  • Patients known to have H. pylori infection diagnosed by histopathology, rapid urease test and urea breath test
  • Failure to respond to classical triple regime of amoxicillin 1gram, clarithromycin 500mg and omeprazole 20mg twice a day for 10-14 days as documented by repeat urea breath test done one month after eradication therapy -

Exclusion Criteria:

  • Evidence of any malignancy, gastric outlet syndrome, history of gastric surgery, chronic liver disease, severe chronic renal failure, or any major co-morbidity.
  • known or suspected hypersensitivity to the medication used in the study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520949

Contacts
Contact: Zaigham Abbas, FACG     92214930051 ext 4659     zaigham@akunet.org    
Contact: Javed Yakoob, PhD     92214864679     yakoobjaved@hotmail.com    

Locations
Pakistan, Sindh
Aga Khan University Hospital     Recruiting
      Karachi, Sindh, Pakistan, 74800
      Contact: Zaigham Abbas, FACG     92214930051     zaigham@akunet.org    
      Principal Investigator: Zaigham Abbas, FACG            
      Sub-Investigator: Javed Yakoob, PhD            
      Sub-Investigator: Shahab Abid, FRCP            
      Sub-Investigator: Wasim Jafri, FACG            

Sponsors and Collaborators
Aga Khan University

Investigators
Principal Investigator:     Zaigham Abbas, FACG     Aga Khan University    
  More Information

Study ID Numbers:   609-Med
First Received:   August 24, 2007
Last Updated:   August 24, 2007
ClinicalTrials.gov Identifier:   NCT00520949
Health Authority:   Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
H.pylori  
Triple therapy failure  
Quadruple therapy  

Study placed in the following topic categories:
Bismuth tripotassium dicitrate
Amoxicillin
Clavulanic Acid
Omeprazole
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Bismuth

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Antacids
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008




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