Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia
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Purpose
More than half of the world's population is infected with Helicobacter pylori, a bacterium that colonizes the human stomach. Although most infected subjects live free of symptoms and disease outcomes (except superficial gastritis), only a few develop peptic ulcers or gastric cancer, while some others may develop non-ulcer dyspepsia. Current clinical practice for the management of peptic ulcer disease includes testing for and treating H. pylori, if present. Although there are triple therapies that contain 2 antibiotics plus a bismuth compound, a proton-pump inhibitor, or a H2-receptor antagonist which are effective at eliminating H. pylori in Europe and North America, these treatments are dramatically less effective in developing countries. Our recent meta-analysis showed quadruple therapies containing clarithromycin, amoxicillin, metronidazole and a proton pump inhibitor to be effective in the presence of clarithromycin or metronidazole resistance. However, this regimen has yet to be tested in a developing country. Therefore, in the current randomized clinical trial in Pasto, Colombia, we aim to examine the effectiveness of clarithromycin, amoxicillin, metronidazole with and without a proton pump inhibitor compared to the Food and Drug Administration approved 10-day regimen containing clarithromycin, amoxicillin and omeprazole. Since antibiotic therapy is most effective within a specific gastric pH range, and since mutifocal atrophy results in damage and loss of the acid producing parietal cells, we will test the efficacy of our modified therapy stratified by diagnosis of multifocal atrophic gastritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Helicobacter Pylori Infection |
Drug: Clarithromycin, Metronidazole, Amoxicillin (+Omeprazole) Drug: Clarithromycin, Amoxicillin, Omeprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Clinical Trial to Examine the Efficacy of a Clarithromycin-, Amoxicillin-, and Metronidazole-Based Regimen to Eradicate Helicobacter Pylori Infections in Pasto, Colombia |
- Helicobacter pylori eradication determined by 13C-urea breath test. [ Time Frame: 4-6 weeks following the completion of treatment ] [ Designated as safety issue: No ]
- Dyspeptic symptom resolution ascertained by self-report. [ Time Frame: 4-6 weeks following the completion of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 151 |
| Study Start Date: | April 2006 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Clarithromycin 500 mg bid, metronidazole 500 mg tid, and amoxicillin 500mg tid for 14 days (with or without omeprazole 20 mg bid)
|
Drug: Clarithromycin, Metronidazole, Amoxicillin (+Omeprazole)
Clarithromycin 500 mg bid, metronidazole 500 mg tid, and amoxicillin 500mg tid with or without omeprazole 20 mg bid for 14 days
Other Name: Biaxin, Flagyl, Amoxil, Prilosec
|
|
Active Comparator: 2
Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days
|
Drug: Clarithromycin, Amoxicillin, Omeprazole
Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days
Other Name: Biaxin, Amoxil, Prilosec
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 29 Years to 77 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 29-77 years; have lived in Pasto, Colombia for at least 5 years and plan to remain in Pasto for ≥5 more years;
- Currently have Helicobacter pylori infection;
- Willing to refrain from alcohol consumption for 2 weeks;
- Have never taken a therapy to eradicate Helicobacter pylori;
- Have not taken antibiotics, bismuth compounds, proton-pump inhibitors, H2-receptor antagonists, or antacids within 30 days of the trial;
- Are not pregnant, and have little or no risk of pregnancy.
Exclusion Criteria:
- History of kidney, liver, heart, or mental disease;
- Frequent alcohol consumption;
- Allergic to clarithromycin, amoxicillin, penicillin, omeprazole or metronidazole;
- Currently taking drugs which may interact with any of the trial medications.
Contacts and Locations| Colombia | |
| Universidad del Valle | |
| Cali, Colombia | |
| Principal Investigator: | Lori A Fischbach, PhD, MPH | University of North Texas Health Science Center |
| Study Chair: | Pelayo Correa, MD | Vanderbilt University |
| Study Director: | Luis E Bravo, MD | Universidad del Valle |
More Information
No publications provided by University of North Texas Health Science Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Lori A. Fischbach, University of North Texas Health Science Center |
| ClinicalTrials.gov Identifier: | NCT00719420 History of Changes |
| Other Study ID Numbers: | 06-02-24-2 |
| Study First Received: | July 11, 2008 |
| Last Updated: | July 18, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Texas Health Science Center:
|
Randomized clinical trial Helicobacter pylori clarithromycin metronidazole |
amoxicillin proton pump inhibitor Colombia |
Additional relevant MeSH terms:
|
Helicobacter Infections Gram-Negative Bacterial Infections Bacterial Infections Amoxicillin Clarithromycin Metronidazole Omeprazole Proton Pump Inhibitors Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013