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

Aga Khan University

Status

Completed

Conditions

Treatment of Helicobacter Pylori

Treatments

Drug: Cebes (colloidal bismuth subcitrate)

Drug: Augmentin (Amoxicillin-clavulanic)

Drug: Furoxone (furazolidone)

Drug: Esso (esomeprazole)

Study type

Interventional

Funder types

Other

Identifiers

NCT00520949

609-Med

Details and patient eligibility

About

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.

Enrollment

176 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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