Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice

NCT01273441 | Completed Phase 4

• 1 other identifier: SEQvsCONC (TRA-047)
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 11

Brief Summary

Helicobacter pylori is the main cause of chronic gastritis, peptic ulcer and gastric tumors (adenocarcinoma and lymphoma). The cure of the H. pylori infection prevents recurrence of duodenal and gastric ulcer and improves dyspepsia in a significant proportion of cases, so it is cost-effective. Eradication therapy has changed over time. The usually recommended pattern in the consensus conferences has traditionally been triple therapy, composed by the combination of 2 antibiotics (clarithromycin plus amoxicillin or metronidazole) and a proton pump inhibitor (PPI) for 7-14 days. Recent meta-analyses have that the current global eradication rate after standard triple therapy is less than 80%. Several European studies have found even lower eradication rates, with 35-40% of cases resulting in treatment failure. Treatment failure leads to a second treatment and a new diagnostic test to confirm eradication.

Conditions

Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

• "Intention to treat" eradication rates

  "Intention-to-treat" eradication of infection.

  One year

Secondary Outcomes (4)

• "Per protocol" Eradication rate

  One year

• Compliance

  One year

• Adverse events

  One year

• Clinical and demographic variables

  One year

Study Arms (2)

Sequential treatment:

ACTIVE COMPARATOR

Drug: PPI, amoxicillin, metronidazole and clarithromycin

Concomitant treatment

EXPERIMENTAL

Drug: PPI, amoxicillin, metronidazole and clarithromycin

Interventions

PPI, amoxicillin, metronidazole and clarithromycin DRUG

Dual therapy for 5 days: PPI and 1g amoxicillin every 12h. After dual therapy continue with a triple therapy for 5 days: PPI, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h.

Sequential treatment:

Eligibility Criteria

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

You may qualify if:

• Requirement of confirmation of the diagnosis of H. pylori infection by at least one positive test out of the following: breath test, histology, rapid urease test or culture.

You may not qualify if:

• Age less than 18 years.
• Advanced chronic disease or any other pathology that prevents attending controls and follow up.
• Allergy to any of the antibiotics in the treatment.
• Previous gastric surgery
• Pregnancy and lactation.
• History of alcohol or drug abuse.
• Previous eradication treatment.
• Consumption of antibiotics or bismuth salts during the last 4 weeks

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead

Study Sites (11)

Hospital del Mar

Barcelona, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, Spain

Location

Hospital de Cabueñes

Gijón, Spain

Location

Hospital San Jorge

Huesca, Spain

Location

Hospital Universitario de La Princesa

Madrid, Spain

Location

Hospital Costa del Sol

Málaga, Spain

Location

Hospital de Sabadell

Sabadell, Spain

Location

Hospital Universitario de Valme

Seville, Spain

Location

Hospital Mútua de Terrassa

Terrassa, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Spain

Location

Hospital Clínico Universitario "Lozano Blesa"

Zaragoza, Spain

Location

Related Publications (34)

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  PMID: 23665990 DERIVED

MeSH Terms

Interventions

Amoxicillin; Metronidazole; Clarithromycin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Javier P. Gisbert, Physician Doctor

  Digestive Service, Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: December 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

ES (11)