Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00520949

Acronym

QT-Hp

Enrollment

176

Registered

2007-08-27

Start date

2006-10-31

Completion date

2008-06-30

Last updated

2009-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Helicobacter Pylori

Keywords

H.pylori, Triple therapy failure, Quadruple therapy

Brief summary

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.

Interventions

DRUGAugmentin (Amoxicillin-clavulanic)

Amoxicillin-clavulanic acid 1 gram b.i.d

DRUGFuroxone (furazolidone)

furazolidone 200 mg b.i.d

DRUGCebes (colloidal bismuth subcitrate)

colloidal bismuth subcitrate 240 mg b.i.d

DRUGEsso (esomeprazole)

esomeprazole 40 mg b.i.d for 14 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Eradication of H. pylori infection resistant to triple therapy.	6 weeks

Secondary

Measure	Time frame
Safety of the quadruple therapy	6 weeks

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026