Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Helicobacter Pylori |
Drug: PPI, amoxicillin, metronidazole and clarithromycin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 4, Prospective, Randomized and Comparative Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice |
- "Intention to treat" eradication rates [ Time Frame: One year ] [ Designated as safety issue: No ]"Intention-to-treat" eradication of infection.
- "Per protocol" Eradication rate [ Time Frame: One year ] [ Designated as safety issue: No ]"Per protocol" eradication of infection.
- Compliance [ Time Frame: One year ] [ Designated as safety issue: No ]Treatment compliance
- Adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]Adverse events
- Clinical and demographic variables [ Time Frame: One year ] [ Designated as safety issue: No ]Age Sex Smoking habits Comorbidity (diabetes mellitus, arterial hypertension, ischemic heart disease, dyslipidemia, others) Indication for eradication (peptic ulcer vs. uninvestigated or functional dyspepsia) Initial diagnostic test for H. pylori infection.
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Sequential treatment: |
Drug: PPI, amoxicillin, metronidazole and clarithromycin
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.
|
| Experimental: Concomitant treatment |
Drug: PPI, amoxicillin, metronidazole and clarithromycin
Quadruple therapy for ten days:PPI, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h
|
Detailed Description:
Justification of the study:
One of the latest therapeutic innovations is sequential therapy, introduced in Italy by Zullo et al. The drug delivery strategy involves a 5-day induction phase with dual therapy (a PPI every 12 hours and amoxicillin 1g every 12 hours), followed immediately by triple therapy for 5 days with a PPI every 12 hours, metronidazole 500 mg every 12 hours and clarithromycin 500 mg every 12 hours. Sequential therapy has proved more effectiveness than standard triple therapy for seven and ten days. In order to assess the efficacy of this new treatment in our area, over the past year we conducted a multicentre observational pilot study in routine clinical practice conditions in patients infected with H. pylori and with indications for eradication. 139 patients from 6 different centres were included. Excellent treatment compliance and minimal side effects, similar to those described with triple therapy, were shown. The results confirm similar efficacy to that obtained in previous studies and an eradication rate significantly higher than that obtained with classic triple therapy in our area.
Several previous studies have shown excellent efficacy of quadruple therapy with a PPI, amoxicillin, clarithromycin and metronidazole, administering "concomitantly" the same drugs as those of sequential therapy, but only for 5-7 days. Several studies have found a higher eradication rate of this "concomitant" therapy as compared with classic triple therapy. The results of a randomized study in which sequential and concomitant therapy were compared have recently been reported in the American Congress of Gastroenterology. Eradication and adverse events rates were similar with both treatments. This data suggest that the "sequentially"administration of these drugs probably complicated unnecessarily the treatment.
Therefore it is necessary to make a controlled clinical trial to directly compare "sequential" versus "concomitant" therapy. The results of this study will conclude which should be the first line treatment for H. pylori eradication.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Inclusion of patients with dyspepsia or peptic gastroduodenal ulcer for whom eradication treatment is indicated.
- 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.
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Javier P. Gisbert, Physician Doctor | +34 913093911 | gisbert@meditex.es |
| Spain | |
| Hospital del Mar | Not yet recruiting |
| Barcelona, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Felipe Bory Ros, Physician Doctor | |
| Hospital San Pedro de Alcántara | Not yet recruiting |
| Cáceres, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Javier Molina Infante, Physician Doctor | |
| Hospital de Cabueñes | Not yet recruiting |
| Gijón, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Cristobal de la Coba, Physician Doctor | |
| Hospital San Jorge | Not yet recruiting |
| Huesca, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Miguel Montoro, Physician Doctor | |
| Hospital Universitario de La Princesa | Recruiting |
| Madrid, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Dr. Javier P. Gisbert, Physician Doctor | |
| Hospital Costa del Sol | Not yet recruiting |
| Málaga, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Ángeles Pérez Aisa, Physician Doctor | |
| Hospital de Sabadell | Not yet recruiting |
| Sabadell, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Xavier Calvet, Physician Doctor | |
| Hospital Universitario de Valme | Not yet recruiting |
| Sevilla, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Manuel Castro, Physician Doctor | |
| Hospital Mútua de Terrassa | Not yet recruiting |
| Terrassa, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Montserrat Forne, Physician Doctors | |
| Hospital Universitario Río Hortega | Not yet recruiting |
| Valladolid, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Jesús Barrio, Physician Doctor | |
| Hospital Clínico Universitario "Lozano Blesa" | Not yet recruiting |
| Zaragoza, Spain | |
| Contact: Javier P. Gisbert, Physician Doctor +34 913093911 gisbert@meditex.es | |
| Principal Investigator: Julio Ducóns, Physician Doctor | |
| Principal Investigator: | Javier P. Gisbert, Physician Doctor | Digestive Service, Hospital Universitario de La Princesa |
More Information
Publications:
| Responsible Party: | Hospital Universitario de la Princesa |
| ClinicalTrials.gov Identifier: | NCT01273441 History of Changes |
| Other Study ID Numbers: | SEQvsCONC (TRA-047) |
| Study First Received: | January 7, 2011 |
| Last Updated: | December 5, 2011 |
| Health Authority: | Drug Agency in Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Additional relevant MeSH terms:
|
Amoxicillin Clarithromycin Metronidazole Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013