Randomised multicentric controlled clinical trial to compare efficacy of rifabutin-based therapy versus quadruple therapy as second-line treatment in the infection of Helicobacter pylori
- Conditions
- Helicobacter pylori infection after failed first treatmentDigestive SystemHelicobacter pylori infection
- Registration Number
- ISRCTN81058036
- Lead Sponsor
- Andalusian Digestive Disease Society (Sociedad Andaluza de Patología Digestiva) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 206
Patients in whom Helicobacter pylori infection persisted after a triple therapy treatment were included.
1. Withheld consent
2. Had initially been treated by the Test and Treat procedure, or a baseline endoscopy was not obtained
3. Fulfilment of the treatment regimen and attendance at follow-up appointments could not reasonably be expected
4. Human Immunodeficiency Virus (HIV) positive status
5. Active alcoholism
6. Addiction to drugs
7. Age less than 18 years or more than 75 years
8. The suspicion of tuberculous infection
9. Either because of a positive intradermal reaction to Mantoux and compatible thorax radiography, or if the patient had previously received tuberculostatic treatment, or a known allergy to any of the components of either of the two treatment regimens
10. Received quadruple therapy as first-line treatment, or any other treatment including bismuth (e.g., ranitidine bismuth citrate), or antibiotics during the previous month
11. Severe associated diseases:
a. cardiac insufficiency
b. respiratory insufficiency
c. chronic kidney insufficiency
d. hepatic insufficiency
e. advanced neoplasic diseases
12. Pregnant or lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy assesed by urea breath test, measured 45 days after completion of the treatment.
- Secondary Outcome Measures
Name Time Method Adverse events at the completion of the treatment, and 45 days after the completion of the treatment.