Pulmonary DiseasesPhase 4NCT00367913
Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease
A Phase 4 study testing Addition of clarithromycin to rifampicin and ethambutol, Addition of Ciprofloxacin to rifampicin and ethambutol and Vaccination with M.vaccae in people with Pulmonary Diseases, run by British Thoracic Society at 1 site in United Kingdom.
Trial summary
To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active in vitro against these species of mycobacteria. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pulmonary Diseases
- What is being tested?
- Addition of clarithromycin to rifampicin and ethambutol, Addition of Ciprofloxacin to rifampicin and ethambutol and Vaccination with M.vaccae
- Type of treatment
- Vaccines
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 1995to Sep 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with pulmonary disease due to M.avium intracellulare, M.malmoense or M.xenopi. Aged 16 or over. With clinical and/or radiological evidence of active infection and producing sputum positive on culture on at least 2 occasions.
Who cannot join
- Pregnant women and women of childbearing age not taking adequate contraceptive precautions.
- Patients who have sputum currently positive on culture for M.tuberculosis or M.bovis.
- Patients who have AIDS or who are known to be HIV positive
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Llandough Hospital
Penarth, Vale of Glamorgan, CF64 2XX
About this study
Official title: Treatment of Pulmonary Disease Caused by MAIS, M.Xenopi or M.Malmoense: A Comparison of Two Triple Drug Regimens and an Assessment of the Value of Immunotherapy With M.Vaccae
To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active in vitro against these species of mycobacteria. The primary aim of this study was to compare these to agents as supplements to rifampicin and ethambutol. A secondary aim was to assess the vale of immunotherapy with M.vaccae.
- Conditions
- Pulmonary Diseases
- Being tested
- Addition of clarithromycin to rifampicin and ethambutol, Addition of Ciprofloxacin to rifampicin and ethambutol, Vaccination with M.vaccae
- Keywords
- pulmonary disease, Treatment of Opportunist Mycobacteria, Clarithromycin, Ciprofloxacin, M.vaccae, Pulmonary diseases caused by Opportunist Mycobacteria
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of clarithromycin to rifampicin and ethambutolDrug
Addition of Ciprofloxacin to rifampicin and ethambutolDrug
Vaccination with M.vaccaeBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Death rates
Cure rates
Relapse rates
Unwanted effects of therapy
Secondary outcomes (1)
Benefit or not of immunotherapy with M.vaccae
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startMar 1995
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- British Thoracic Society
- Sponsor type
- University, hospital or other
- Investigators
- Ian Campbell, BSc MD FRCP, Principal investigator, British Thoracic Society, Research Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367913
- Sponsor's protocol ID
- BTS Opportunist Mycobacteria
- Status last verified
- Jul 2006
- First submitted
- 21 Aug 2006
- Last updated
- 23 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pulmonary Disease Caused by MAIS, M.Xenopi or M.Malmoense: A Comparison of Two Triple Drug Regimens and an Assessment of the Value of Immunotherapy With M.Vaccae
- ClinicalTrials.gov ID
- NCT00367913
- Acronym / sponsor ID
- BTS Opportunist Mycobacteria
- Conditions
- Pulmonary Diseases
- Keywords
- pulmonary disease, Treatment of Opportunist Mycobacteria, Clarithromycin, Ciprofloxacin, M.vaccae, Pulmonary diseases caused by Opportunist Mycobacteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- British Thoracic SocietyUniversity, hospital or other
- Study start
- Mar 1995
- Study completion
- Sep 2004
- First posted
- 23 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active in vitro against these species of mycobacteria. The primary aim of this study was to compare these to agents as supplements to rifampicin and ethambutol. A secondary aim was to assess the vale of immunotherapy with M.vaccae.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pulmonary disease due to M.avium intracellulare, M.malmoense or M.xenopi. Aged 16 or over. With clinical and/or radiological evidence of active infection and producing sputum positive on culture on at least 2 occasions.
Key exclusion criteria (3 listed)
- Pregnant women and women of childbearing age not taking adequate contraceptive precautions.
- Patients who have sputum currently positive on culture for M.tuberculosis or M.bovis.
- Patients who have AIDS or who are known to be HIV positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Addition of clarithromycin to rifampicin and ethambutol | Drug | – |
| Addition of Ciprofloxacin to rifampicin and ethambutol | Drug | – |
| Vaccination with M.vaccae | Biological | – |
Primary outcome
Death rates
Cure rates
Relapse rates
Unwanted effects of therapy
1 secondary outcome
Benefit or not of immunotherapy with M.vaccae
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Campbell, BSc MD FRCP principal investigator
British Thoracic Society, Research Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Addition of clarithromycin to rifampicin and ethambutol, Addition of Ciprofloxacin to rifampicin and ethambutol and Vaccination with M.vaccae in people with Pulmonary Diseases, run by British Thoracic Society at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death rates. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2006.