Condition category
Digestive System
Date applied
20/03/2007
Date assigned
25/04/2007
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr José Ma Navarro-Jarabo

ORCID ID

Contact details

Unidad de Aparato Digestivo
Hospital Costa de Sol
Malaga
Marbella
29603
Spain

Additional identifiers

EudraCT number

2004-001320-20

ClinicalTrials.gov number

Protocol/serial number

HP-R/2003

Study information

Scientific title

Acronym

Study hypothesis

Rifabutin-based therapy will achieve an eradication rate of Helicobacter infection similar to quadruple therapy as a second-line treatment.

Ethics approval

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.

Study design

Randomised multicentric open clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Rifabutin, omeprazole, metranidazole, tetracycline and bismuth

Primary outcome measures

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 trial start date

01/09/2004

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

206

Participant 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

Recruitment start date

01/09/2004

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Spain

Trial participating centre

Unidad de Aparato Digestivo
Marbella
29603
Spain

Sponsor information

Organisation

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

Sponsor details

A7 Km 187 s/n
Marbella
29603
Spain

Sponsor type

Hospital/treatment centre

Website

http://www.sapd.org

Funders

Funder type

Government

Funder name

Andalucia Health Committee (Consejería de Salud de la Junta de Andalucía) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fundación Hospital Costa del Sol de Marbella (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17651479

Publication citations

  1. Results

    Navarro-Jarabo JM, Fernández N, Sousa FL, Cabrera E, Castro M, Ramírez LM, Rivera R, Ubiña E, Vera F, Méndez I, Rivas-Ruiz F, Moreno JL, Perea-Milla E, Efficacy of rifabutin-based triple therapy as second-line treatment to eradicate helicobacter pylori infection., BMC Gastroenterol, 2007, 7, 31, doi: 10.1186/1471-230X-7-31.

Additional files

Editorial Notes