A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
Information source: American University of Beirut Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Infections
Intervention: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: American University of Beirut Medical Center Official(s) and/or principal investigator(s): Ala' I Sharara, MD, Principal Investigator, Affiliation: American University of Beirut Medical Center
Summary
The proposed study will test the hypothesis that H. pylori can be eradicated successfully
(>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen:
rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in
patients with peptic ulcers and H. pylori related gastritis.
Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be
enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests,
documenting H. pylori infection, will be randomized into one of two groups: Full dose or half
dose the concomitant regimen, with 100 patients in each group. Compliance and side effects
will be assessed, and a urea breath test will be done for all patients after 4 weeks of
therapy completion to evaluate eradication rates. Success of therapy will be evaluated
according to intent-to treat and per-protocol analyses.
Clinical Details
Official title: A Randomized Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of participants with negative urea breath test post treatment
Secondary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Detailed description:
Infection with H. pylori has been linked with chronic active gastritis, peptic ulcer
disease, adenocarcinoma and Non-Hodgkin's lymphoma of the stomach. Eradication of this
organism has been recommended for patients with peptic ulcer disease, low-grade gastric
mucosa-associated lymphoid tissue lymphoma, atrophic gastritis, unexplained iron deficiency
anemia, chronic idiopathic thrombocytopenic purpura, as well as first-degree relatives of
gastric cancer patients.
Guidelines still recommend using triple therapy regimen of PPI, clarithromycin and
amoxicillin/metronidazole twice daily for 7 to 14 days. Over the years, it has become clear
that the first-line triple therapy is loosing efficacy worldwide with PP and ITT eradication
rates inferior to 80%. Antimicrobial resistance plays an important role in some of these
failures.
Major H. pylori study groups in the world have agreed that alternative treatment regimens
are urgently needed. So far, 2 alternative treatment regimens have shown superiority over
the first-line treatment protocols: the sequential therapy consisting of a combination of
amoxicillin and a PPI twice a day for 5 days followed by another 5 days of the PPI plus
clarithromycin and tinidazole/metronidazole, and the concomitant non-bismuth quadruple
regimen consisting of PPI, clarithromycin, metronidazole, and amoxicillin twice daily.
The proposed study will test the hypothesis that H. pylori can be eradicated successfully
(>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen:
rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in
patients with peptic ulcers and H. pylori related gastritis.
Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be
enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests,
documenting H. pylori infection, will be randomized into one of two groups: Full dose or half
dose the concomitant regimen, with 100 patients in each group. Compliance and side effects
will be assessed, and a urea breath test will be done for all patients after 4 weeks of
therapy completion to evaluate eradication rates. Success of therapy will be evaluated
according to intent-to treat and per-protocol analyses.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- documented H. pylori infection by a CLO test or a Urea Breath Test
- sign the informed consent
Exclusion Criteria:
- Age under 18 or older than 80 years
- Allergies to any of the drugs used
- Recent antibiotic therapy (within 2 weeks of enrolment)
- Severe ulcers or bleeding
- Gastric perforation or obstruction
- Previous gastrectomy
- Gastric cancer
- Pregnancy or lactation
- Prior eradication therapy for H. pylori
- Severe concomitant disease or condition making the treatment unlikely to be effective
i. e. alcoholism, drug addiction, and history of poor compliance.
Locations and Contacts
American University of Beirut - Medical Center, Beirut, Lebanon
Additional Information
Starting date: October 2010
Last updated: January 24, 2014
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