Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia

NCT00719420 | Completed Phase 3

• 1 other identifier: 06-02-24-2
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori Infection

Keywords

Randomized clinical trial; Helicobacter pylori; clarithromycin; metronidazole; amoxicillin; proton pump inhibitor; Colombia

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication determined by 13C-urea breath test.

  4-6 weeks following the completion of treatment

Secondary Outcomes (1)

• Dyspeptic symptom resolution ascertained by self-report.

  4-6 weeks following the completion of treatment

Study Arms (2)

1

EXPERIMENTAL

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)

2

ACTIVE COMPARATOR

Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days

Drug: Clarithromycin, Amoxicillin, Omeprazole

Interventions

Clarithromycin, Metronidazole, Amoxicillin (+Omeprazole) DRUG

Clarithromycin 500 mg bid, metronidazole 500 mg tid, and amoxicillin 500mg tid with or without omeprazole 20 mg bid for 14 days

Also known as: Biaxin, Flagyl, Amoxil, Prilosec

1

Clarithromycin, Amoxicillin, Omeprazole DRUG

Clarithromycin 500 mg bid, amoxicillin 1 g bid, and omeprazole 20 mg bid for 10 days

Also known as: Biaxin, Amoxil, Prilosec

2

Eligibility Criteria

• Age: 29 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• Universidad del Valle, Colombia: collaborator
• Vanderbilt University: collaborator

Study Sites (1)

Universidad del Valle

Cali, Colombia

Location

Related Publications (1)

• Fischbach LA, Bravo LE, Zarama GR, Bravo JC, Ojha RP, Priest EL, Collazos T, Casabon AL, Guerrero LZ, Singh KP, Correa P. A randomized clinical trial to determine the efficacy of regimens containing clarithromycin, metronidazole, and amoxicillin among histologic subgroups for Helicobacter pylori eradication in a developing country. Helicobacter. 2009 Apr;14(2):100-8. doi: 10.1111/j.1523-5378.2009.00667.x.

  PMID: 19298337 DERIVED

MeSH Terms

Interventions

Clarithromycin; Metronidazole; Amoxicillin; Omeprazole

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles

Study Officials

• Lori A Fischbach, PhD, MPH

  University of North Texas Health Science Center

  PRINCIPAL INVESTIGATOR

• Pelayo Correa, MD

  Vanderbilt University

  STUDY CHAIR

• Luis E Bravo, MD

  Universidad del Valle

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 21, 2008
• Study Start: April 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: July 21, 2008

Record last verified: 2008-07

Locations

CO (1)