Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).
Prevention of gastric cancer through eradication of H. pylori is one of the most promising strategies to reduce the global impact of cancer in the near term. Our long-term goal is to prevent gastric cancer by developing and validating an effective, simple, and low-cost approach to eradication of H. pylori. Our immediate goal, therefore, is to conduct a randomized study to compare the effectiveness of three different drug regimens for H. pylori infection. The three study arms are: Standard therapy - 14 day, 3-drug regimen of Lansoprazole, amoxicillin and clarithromycin (PACx14); Concomitant therapy - 5 day, 4-drug regimen of lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential therapy - 10 day, 4-drug regimen of lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Standard 14 day, 3-drug regimen |
|
| Arm 2 | Experimental | Concomitant Therapy - 5 day, 4-drug regimen |
|
| Arm 3 | Experimental | Sequential Therapy - 10 day, 4-drug regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACx14 | Drug | Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization. | week 6 post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary aims will examine infection rates at 1 year, safety and tolerability of these regimens,& potential differential effects among selected groups. | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| E. Robert Greenberg, M.D. | SWOG Cancer Research Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidad Catolica de Chile | Santiago | Chile | ||||
| Universidad del Valle |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23403682 | Derived | Morgan DR, Torres J, Sexton R, Herrero R, Salazar-Martinez E, Greenberg ER, Bravo LE, Dominguez RL, Ferreccio C, Lazcano-Ponce EC, Meza-Montenegro MM, Pena EM, Pena R, Correa P, Martinez ME, Chey WD, Valdivieso M, Anderson GL, Goodman GE, Crowley JJ, Baker LH. Risk of recurrent Helicobacter pylori infection 1 year after initial eradication therapy in 7 Latin American communities. JAMA. 2013 Feb 13;309(6):578-86. doi: 10.1001/jama.2013.311. | |
| 21777974 |
| Label | URL |
|---|---|
| Click here for more information about the study: S0701, "A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori." | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PACMx5 | Drug | Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5) |
|
|
| PAx5/PCMx5 | Drug | Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5) |
|
|
| Cali |
| Valle del Cauca Department |
| Colombia |
| Fundacion Inciensa | San José | Costa Rica |
| Hospital Occidente | Copán | Honduras |
| National Institute for Public Health | Cuernavaca | Morelos | Mexico |
| Instituto Technologico de Sonora | Obregón | Sonora | Mexico |
| Centro de Investigacion en Demografia y Salud de la Iglesia Merced | León | Nicaragua |
| Derived |
| Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Pena R, Pena EM, Salazar-Martinez E, Correa P, Martinez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011 Aug 6;378(9790):507-14. doi: 10.1016/S0140-6736(11)60825-8. Epub 2011 Jul 21. |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |