Mycobacterium Avium Complex Lung DiseasePhase 4NCT00598897
Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease
A Phase 4 study testing clarithromycin, rifabutin in people with Mycobacterium Avium Complex Lung Disease, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
Trial summary
To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Avium Complex Lung Disease
- What is being tested?
- clarithromycin, rifabutin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1995to 18 May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet American Thoracic Society criteria for nontuberculous mycobacterial lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
- Adults age 18 and older
- Pretreatment isolate of M. avium complex available for MIC determination
Who cannot join
- History of allergy to study drugs
- If a mensruating female, not pregnant and on adequate birth control.
- Children less than 18 years of age
- HIV + or at high risk for HIV infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
About this study
Official title: Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease
To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week
Read the detailed description
Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin
- Conditions
- Mycobacterium Avium Complex Lung Disease
- Being tested
- clarithromycin, rifabutin
- Keywords
- MAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin, rifabutinDrug
Also called Biaxin, mycobutin
Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.
| Study group | Role | What they receive |
|---|---|---|
| clarithromycin and rifabutin/rifampin | Experimental | Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly. Receives: Drug: clarithromycin, rifabutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
sputum conversion culture neg x3
Measured: 6 months
Secondary outcomes (1)
Clinical and microbiological outcomes
culture neg 1 yr on treatment
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startAug 1995
- Primary completion7 Aug 2002
- Study completion18 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Avium Complex Lung DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at Tyler
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Pfizer
- Responsible party
- Principal investigator, Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
- Investigators
- Richard J Wallace Jr., M.D., Principal investigator, The University of Texas Health Science Center at Tyler
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598897
- Sponsor's protocol ID
- 447
- Status last verified
- May 2017
- First submitted
- 11 Jan 2008
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease
- ClinicalTrials.gov ID
- NCT00598897
- Acronym / sponsor ID
- 447
- Conditions
- Mycobacterium Avium Complex Lung Disease
- Keywords
- MAC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at TylerUniversity, hospital or other
- Collaborators
- Abbott, Pfizer
- Study start
- Aug 1995 (actual)
- Primary completion
- 7 Aug 2002 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 23 Jan 2008 (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 determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week
Detailed description
Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clarithromycin and rifabutin/rifampin | Experimental | Drug: clarithromycin, rifabutinClarithromycin and rifabutin/rifampin with ethambutol given three times weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet American Thoracic Society criteria for nontuberculous mycobacterial lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
- Adults age 18 and older
- Pretreatment isolate of M. avium complex available for MIC determination
Key exclusion criteria (4 listed)
- History of allergy to study drugs
- If a mensruating female, not pregnant and on adequate birth control.
- Children less than 18 years of age
- HIV + or at high risk for HIV infection.
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 |
|---|---|---|
| clarithromycin, rifabutinAlso: Biaxin, mycobutinClarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors. | Drug | clarithromycin and rifabutin/rifampin |
Primary outcome
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Time frame: 6 months
sputum conversion culture neg x3
1 secondary outcome
Clinical and microbiological outcomes
Time frame: 1 yr
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 May 2017.
- Individual participant dataSharing planned: No. No plan to share.
Related trials for Mycobacterium Avium Complex Lung Disease
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Short-term Bactericidal Effect of Contezolid in MAC-PD
Mycobacterium Avium Complex Pulmonary Disease
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Hypertonic Saline for MAC
Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection
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A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
Mycobacterium Avium Complex Pulmonary Disease
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.
Richard J Wallace Jr., M.D. principal investigator
The University of Texas Health Science Center at Tyler
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 clarithromycin, rifabutin in people with Mycobacterium Avium Complex Lung Disease, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
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 3 inclusion and 4 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 May 2017. 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 States. 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?
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures (time frame: 6 months). 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 May 2017.