Skip to content

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81058036
Enrollment
206
Registered
2007-04-25
Start date
2004-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection after failed first treatment Digestive System Helicobacter pylori infection

Interventions

Allocated the patients to two options of therapy: 1. Experimental: omeprazol 20 mg/12 hours and amoxicillin 1 gr/12 hours and rifabutin 150 mg/12 hours for seven days 2. Control therapy: omeprazol 20

Sponsors

Andalusian Digestive Disease Society (Sociedad Andaluza de Patología Digestiva) (Spain)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients in whom Helicobacter pylori infection persisted after a triple therapy treatment were included.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Efficacy assesed by urea breath test, measured 45 days after completion of the treatment.

Secondary

MeasureTime frame
Adverse events at the completion of the treatment, and 45 days after the completion of the treatment.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026