Antimicrobial Susceptibility for Helicobacter Pylori Eradication
Palavras-chave
Resumo
Descrição
Usefulness of antimicrobial susceptibility in the eradication of Helicobacter pylori
PURPOSE
Background:
- The rate of eradication of Helicobacter pylori with standard triple therapy (OCA: omeprazole + clarithromycin + amoxicillin) in our area is less than the expected according to the III Maastricht III consensus. However, the current guidelines recommend the use of this therapy.
- According to the Maastricht III consensus, in populations with high rates of clarithromycin resistance (15-20%) another therapy should be considered, or alternatively, testing antimicrobial susceptibility of the H. pylori prior to treatment.
Objectives:
- To clarify the real rate of eradication with OCA therapy with and without antimicrobial susceptibility in our area (with high rate of resistance to clarythromycin).
- To study which is the diagnostic-therapeutic strategy more cost-effective for the treatment of H. pylori.
Design:
- Participants will be screened with a full medical history.
- Participants will aleatory receive OCA therapy empirically, or after antimicrobial susceptibility test if there is no resistance to clarythromycin, for ten days.
- In all cases the eradication of H. pylori will be checked by 13C urea breath test (UBT) in 8 weeks after the therapy have been finished.
- All the adverse event of the therapy will be reported.
datas
| Última verificação: | 11/30/2011 |
| Enviado pela primeira vez: | 11/18/2011 |
| Inscrição estimada enviada: | 12/01/2011 |
| Postado pela primeira vez: | 12/05/2011 |
| Última atualização enviada: | 12/10/2011 |
| Última atualização postada: | 12/12/2011 |
| Data real de início do estudo: | 01/31/2011 |
| Data Estimada de Conclusão Primária: | 10/31/2011 |
| Data Estimada de Conclusão do Estudo: | 04/30/2012 |
Condição ou doença
Intervenção / tratamento
Other: OCA 10
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Empirical OCA This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram. | |
| OCA after antibiogram This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation. |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | All |
| Método de amostragem | Probability Sample |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: - Diagnosis of H. pylori infection provided by culture, histology or UBT. - Patients need and indication to treat (peptic ulcer disease, firs-degree family history of gastric cancer, MALT lymphoma or dyspeptic symptoms) - Patients must be 18 years or older. Exclusion criteria: - Previous treatment for H. pylori eradication. - Patients who have severe concomitant disease. - Patients who have previous gastric surgery. - Patients who have intolerance to any antimicrobial drugs. |
Resultado
Medidas de Resultado Primário
1. Number of patients in whom Helicobacter pylori was eradicated. [9 months]
Medidas de Resultado Secundário
1. Number of patient with adverse event [9 months]
2. Cost of the eradication of Helicobacter Pylori in each group. [9 months]
