Nontuberculous Mycobacterial InfectionsPhase 3NCT03164291
Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex
A Phase 3 study testing Rifabutin in people with Nontuberculous Mycobacterial Infections, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
Trial summary
Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin. Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nontuberculous Mycobacterial Infections
- What is being tested?
- Rifabutin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1984to 18 May 2017
- Phase
- Phase 3
- 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
- Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria
Who cannot join
- Children less than 18 years of age
- Pregnancy
- Low platelet count, except with very serious disease
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: Clinical Efficacy of Rifabutin in the Treatment of Serious and Life Threatening Infections Due to Mycobacterium Avium Complex, or Drug Resistant Mycobacterium Tuberculosis, or Other Drug Resistant Mycobacterium
Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin.
Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.
Read the detailed description
Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.
- Conditions
- Nontuberculous Mycobacterial Infections
- Being tested
- Rifabutin
- Keywords
- MAC and NTM
- Medical subject headings
- Mycobacterium avium-intracellulare Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifabutinDrug
Also called mycobutin
Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status
| Study group | Role | What they receive |
|---|---|---|
| Rifabutin | Experimental | Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin) Receives: Drug: Rifabutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)
neg cultures X3( sputum conversion)
Measured: 6 mos
Secondary outcomes (1)
Microbiological Cultures
neg cultures for 1 yr on treatment
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startJun 1984
- Primary completionSep 2006
- 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 Nontuberculous Mycobacterial InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at Tyler
- Sponsor type
- University, hospital or other
- Collaborators
- 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 Center at TylerWilliam B Girard, MD, Study chair, University of Texas Health Science Center IRB Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164291
- Sponsor's protocol ID
- 072
- Status last verified
- May 2017
- First submitted
- 14 Jan 2008
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- Clinical Efficacy of Rifabutin in the Treatment of Serious and Life Threatening Infections Due to Mycobacterium Avium Complex, or Drug Resistant Mycobacterium Tuberculosis, or Other Drug Resistant Mycobacterium
- ClinicalTrials.gov ID
- NCT03164291
- Acronym / sponsor ID
- 072
- Conditions
- Nontuberculous Mycobacterial Infections
- Keywords
- MAC and NTM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at TylerUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 1984
- Primary completion
- Sep 2006 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 23 May 2017 (actual)
- 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.
Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin.
Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.
Detailed description
Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rifabutin | Experimental | Drug: RifabutinTreatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria
Key exclusion criteria (3 listed)
- Children less than 18 years of age
- Pregnancy
- Low platelet count, except with very serious disease
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 |
|---|---|---|
| RifabutinAlso: mycobutinRifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status | Drug | Rifabutin |
Primary outcome
Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)
Time frame: 6 mos
neg cultures X3( sputum conversion)
1 secondary outcome
Microbiological Cultures
Time frame: 1year
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
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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.
Richard J Wallace, Jr, M.D. principal investigator
The University of Texas Health Center at Tyler
William B Girard, MD study chair
University of Texas Health Science Center IRB Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifabutin in people with Nontuberculous Mycobacterial Infections, 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 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (e.g. clinical symptoms, laboratory cultures) (time frame: 6 mos). 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.