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
| ISRCTN | ISRCTN81058036 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81058036 |
| EudraCT/CTIS number | 2004-001320-20 |
| Secondary identifying numbers | HP-R/2003 |
- Submission date
- 20/03/2007
- Registration date
- 25/04/2007
- Last edited
- 17/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr José Ma Navarro-Jarabo
Scientific
Scientific
Unidad de Aparato Digestivo
Hospital Costa de Sol
Malaga
Marbella
29603
Spain
Study information
| Study design | Randomised multicentric open clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Rifabutin-based therapy will achieve an eradication rate of Helicobacter infection similar to quadruple therapy as a second-line treatment. |
| Ethics approval(s) | Approved on 23/04/2004 by "Comité Autonómico de Ensayos Clinicos de Andalucía" and authorised by " Agencia Española de Medicamentos y Productos Sanitarios" with EudraCT ref 2004-001320-20. |
| Health condition(s) or problem(s) studied | Helicobacter pylori infection after failed first treatment |
| Intervention | 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 mg/12 hours and bismuth 120 mg/6 hours and metronidazole 500 mg/8 hours and tetracycline 500 mg/6 hours for seven days The duration of follow up was 45 days after medications. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rifabutin, omeprazole, metranidazole, tetracycline and bismuth |
| Primary outcome measure | Efficacy assesed by urea breath test, measured 45 days after completion of the treatment. |
| Secondary outcome measures | Adverse events at the completion of the treatment, and 45 days after the completion of the treatment. |
| Overall study start date | 01/09/2004 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 206 |
| Key inclusion criteria | Patients in whom Helicobacter pylori infection persisted after a triple therapy treatment were included. |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Spain
Study participating centre
Unidad de Aparato Digestivo
Marbella
29603
Spain
29603
Spain
Sponsor information
Andalusian Digestive Disease Society (Sociedad Andaluza de Patología Digestiva) (Spain)
Hospital/treatment centre
Hospital/treatment centre
A7 Km 187 s/n
Marbella
29603
Spain
| Website | http://www.sapd.org |
|---|
Funders
Funder type
Government
Andalucia Health Committee (Consejería de Salud de la Junta de Andalucía) (Spain)
No information available
Fundación Hospital Costa del Sol de Marbella (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/07/2007 | Yes | No |
