Five Days Quadruple and Clarithromycin Containing Triple Therapy as Treatment for Helicobacter Pylori Eradication

The University of Hong Kong (HKU)

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Quadruple therapy; Drug: Triple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01306786

HKU-HP1

Details and patient eligibility

About

The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.

Full description

Eligible patients with H pylori infection were randomized to receive either five-day QUAD (esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.) or EAC (esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d.). H. pylori status was rechecked by 13C urea breath test 8 weeks after treatment. Patients who failed their respective therapy were invited to undergo H. pylori susceptibility testing and crossover to receive the alternative regimen for the same duration.

Enrollment: 800 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with H. pylori infection
• did not receive H. pylori eradication therapy before

Exclusion criteria

• patients who have received previous H. pylori eradication therapy
• co-morbidity of liver cirrhosis
• co-morbidity of renal failure
• co-morbidity of alcoholism
• co-morbidity of malignancy
• received antibiotics, bismuth preparations, proton pump inhibitors or probiotic in the preceding three months
• patients with known allergy to the medications used
• patients with a history of previous gastrointestinal diseases or gastric surgery
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Quadruple therapy

Active Comparator group

Description:

First line: 5 days esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d. Cross over second line for those who failed first line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d

Treatment:

Drug: Quadruple therapy

Triple Therapy

Active Comparator group

Description:

First line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d Second line cross over if failed first line: 7 days quadruple therapy: esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.)

Treatment:

Drug: Triple therapy