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OpenTrials
Completed

NCT Number: NCT00520949

Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection

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 14 days.

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Key information

Conditions

Treatment of Helicobacter Pylori

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmentin (Amoxicillin-clavulanic)

Drug

Amoxicillin-clavulanic acid 1 gram b.i.d

Furoxone (furazolidone)

Drug

furazolidone 200 mg b.i.d

Cebes (colloidal bismuth subcitrate)

Drug

colloidal bismuth subcitrate 240 mg b.i.d

Esso (esomeprazole)

Drug

esomeprazole 40 mg b.i.d for 14 days

Primary outcomes

  1. Eradication of H. pylori infection resistant to triple therapy.

    Time frame: 6 weeks

Secondary outcomes

  1. Safety of the quadruple therapy

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy

Acronym: QT-Hp

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 27, 2007
Registry last updated
Apr 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.