M.Abscessus Pulmonary DiseaseNCT04163601
Liposomal Amikacin Inhalation in M.Abscessus Patients
An observational study of M.Abscessus Pulmonary Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Mycobacterium abscessus is one of the many species of non-tuberculous mycobacteria. M. abscessus infections are known to be common in patients with cystic fibrosis (CF). Mycobacterium abscessus yields poor cure rates. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- M.Abscessus Pulmonary Disease
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2019to 31 Mar 2024
- Phase
- Observational
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with M. abscessus disease
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- ATS diagnostic criteria for M.abscessus pulmonary disease
- > 12 years
- Patients with CF/COPD or other underlying disease
- LAI use for more than 3 weeks
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Extra-pulmonary or disseminated disease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
RAPHAEL CHIRON, PU-PH, 467336089 ext. 33, c-chiron@chu-montpellier.fr
About this study
Official title: NTM-net Study: Liposomal Amikacin Inhalation in M.Abscessus Patients
Mycobacterium abscessus is one of the many species of non-tuberculous mycobacteria. M. abscessus infections are known to be common in patients with cystic fibrosis (CF). Mycobacterium abscessus yields poor cure rates. Liposomal amikacin inhalation (LAI) might be a good alternative for intravenous treatment as the first results with mycobacterium avium treatment yield good results.
The objective of this study is to summarize the clinical data of patients with M.abscessus treated with LAI on compassionate use basis to assess treatment outcomes
- Conditions
- M.Abscessus Pulmonary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
culture conversion
Main study endpoints will consist of microbiological cure, clinical cure and treatment culture conversion at the end of treatment. Treatment outcome definitions according to the NTM net consensus are used
Measured: 1 day
Secondary outcomes (1)
clinical cure
Main study endpoints will consist of microbiological cure, clinical cure and treatment culture conversion at the end of treatment. Treatment outcome definitions according to the NTM net consensus are used
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start30 Nov 2019
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for M.Abscessus Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- European network (http://www.ntm-net.org/index.php/ntm-net)
- Responsible party
- Sponsor
- Investigators
- Raphael CHIRON, PU-PH, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163601
- Sponsor's protocol ID
- RECHMPL19_0487
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NTM-net Study: Liposomal Amikacin Inhalation in M.Abscessus Patients
- ClinicalTrials.gov ID
- NCT04163601
- Acronym / sponsor ID
- RECHMPL19_0487
- Conditions
- M.Abscessus Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- European network (http://www.ntm-net.org/index.php/ntm-net)
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 15 Nov 2019 (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.
Mycobacterium abscessus is one of the many species of non-tuberculous mycobacteria. M. abscessus infections are known to be common in patients with cystic fibrosis (CF). Mycobacterium abscessus yields poor cure rates. Liposomal amikacin inhalation (LAI) might be a good alternative for intravenous treatment as the first results with mycobacterium avium treatment yield good results.
The objective of this study is to summarize the clinical data of patients with M.abscessus treated with LAI on compassionate use basis to assess treatment outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with M. abscessus disease
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- ATS diagnostic criteria for M.abscessus pulmonary disease
- > 12 years
- Patients with CF/COPD or other underlying disease
- LAI use for more than 3 weeks
Key exclusion criteria (2 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Extra-pulmonary or disseminated disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
culture conversion
Time frame: 1 day
Main study endpoints will consist of microbiological cure, clinical cure and treatment culture conversion at the end of treatment. Treatment outcome definitions according to the NTM net consensus are used
1 secondary outcome
clinical cure
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Undecided. NC
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.
Raphael CHIRON, PU-PH principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of M.Abscessus Pulmonary Disease, run by University Hospital, Montpellier at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 12 Feb 2020. 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 France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphael CHIRON, PU-PH (467336089 ext. 33, c-chiron@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
culture conversion (time frame: 1 day). 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 12 Feb 2020.