Mycobacterium Abscessus Lung DiseasePhase 2NCT00600600
Tigecycline for Treatment of Rapidly Growing Mycobacteria
A Phase 2 study testing Tigecycline in people with Mycobacterium Abscessus Lung Disease and Rapidly Growing Mycobacterial 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, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Mycobacterium Abscessus Lung Disease, Rapidly Growing Mycobacterial Lung Disease
- What is being tested?
- Tigecycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Dec 2010
- Phase
- Phase 2
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive cultures for rapidly growing mycobacteria
- Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs
- Adults and children 10 years of age and older
- Pretreatment isolate of M. avium complex available for MIC determination
- Available for followup appointments
Who cannot join
- History of tetracycline allergy
- If a menstruating female, not pregnant and on adequate birth control
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: Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)
To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).
Read the detailed description
To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus
- Being tested
- Tigecycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TigecyclineDrug
Also called tygacil
Tigecycline dosage based on age and clinical status of patient.
| Study group | Role | What they receive |
|---|---|---|
| Tigecycline | Experimental | tigecycline titrated dose according to patient age and clinical status Receives: Drug: Tigecycline |
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
culture neg X3 ( sputum conversion)
Measured: 6 mos
Secondary outcomes (1)
clinical and Microbiological outcomes
clinical and radiographic improvements
Measured: 6 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startApr 2002
- Primary completionApr 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycobacterium Abscessus 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at Tyler
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of 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
- NCT00600600
- Sponsor's protocol ID
- 660
- 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
Publications
Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.
PubMed 24633206
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
- Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)
- ClinicalTrials.gov ID
- NCT00600600
- Acronym / sponsor ID
- 660
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at TylerUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Apr 2002
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 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, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).
Detailed description
To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tigecycline | Experimental | Drug: Tigecyclinetigecycline titrated dose according to patient age and clinical status |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Positive cultures for rapidly growing mycobacteria
- Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs
- Adults and children 10 years of age and older
- Pretreatment isolate of M. avium complex available for MIC determination
- Available for followup appointments
Key exclusion criteria (2 listed)
- History of tetracycline allergy
- If a menstruating female, not pregnant and on adequate birth control
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 |
|---|---|---|
| TigecyclineAlso: tygacilTigecycline dosage based on age and clinical status of patient. | Drug | Tigecycline |
Primary outcome
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Time frame: 6 mos
culture neg X3 ( sputum conversion)
1 secondary outcome
clinical and Microbiological outcomes
Time frame: 6 mos
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.
- Derived from this study: PubMed 24633206Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.
- 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 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 2 study testing Tigecycline in people with Mycobacterium Abscessus Lung Disease and Rapidly Growing Mycobacterial 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 5 inclusion and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 mos). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600600, which also lists 1 linked publication.
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.