Dactinomycin Adverse ReactionNCT04414137
Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin
An observational study of Dactinomycin Adverse Reaction and Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria. Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Dactinomycin Adverse Reaction, Bone and Joint Infection
- What is being tested?
- Description of eosinophilic pneumonia due to daptomycine
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2019to 1 Sep 2021
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: patients having had an eosinophilic pneumonia under daptomycine given to treat an osteoarticular infection (BJI/PJI) treated at the CRIOAc Lyon
Who may be able to join
- patients having had an eosinophilic pneumonia under daptomycine given to treat an osteoarticular infection (BJI/PJI)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA
About this study
Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.
Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide.
The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future
Read the detailed description
Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.
The Infectious Diseases Society of America recommends the use of daptomycin 6 mg / kg / day in the second-line treatment of IOA on staphylococcal but also enterococcal prostheses, as an alternative to vancomycin and linezolid.
In case of renal failure, daptomycin is often considered as a good therapeutic alternative to glycopeptides.
Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide. Although a large proportion of cases have been reported in patients receiving daptomycin in unapproved indications, the use of daptomycin in authorized indications has also been associated with this risk.
The dosage of daptomycin makes it possible to evaluate its effectiveness and prevent the occurrence of a overdose, provider of side effects.
The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future
- Being tested
- Description of eosinophilic pneumonia due to daptomycine
- Keywords
- Eosinophilic pneumonia, Daptomycin, Bone and joint infection, Adverse event
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of eosinophilic pneumonia due to daptomycineOther
Description of eosinophilic pneumonia in patients treated by daptomycin for an osteoarticular infection
| Study group | Role | What they receive |
|---|---|---|
| Eosinophilic pneumonia on daptomycin | patients having an osteoarticular infection treated with daptomycin and which developped eosinophilic pneumonia Receives: Other: Description of eosinophilic pneumonia due to daptomycine |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin
description of the BJI/PJI (symptoms, type of evolution, type of implant)
Measured: 2 months
description patients having eosinophilic pneumonia due to daptomycin
description of the patients (average age, medical background)
Measured: 2 months
rate of eosinophilic pneumonia due to daptomycin in osteoarticular infection: the adverse event
number of cases and description of the adverse event as assessed by CTCAE v4.0
Measured: 6 months
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine
description of the use of daptomycine : dosage
Measured: 6 months
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine
description of the use of daptomycine : duration
Measured: 6 months
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance
mean daptomycine plasma clearance (unit, liters per hour)
Measured: 6 months
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution
mean daptomycine volume of distribution (unit, liters)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start19 Feb 2019
- Primary completion20 Jan 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dactinomycin Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414137
- Sponsor's protocol ID
- 19-283
- Status last verified
- Nov 2020
- First submitted
- 12 May 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin
- ClinicalTrials.gov ID
- NCT04414137
- Acronym / sponsor ID
- 19-283
- Keywords
- Eosinophilic pneumonia, Daptomycin, Bone and joint infection, Adverse event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 20 Jan 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 4 Jun 2020 (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.
Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.
Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide.
The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future
Detailed description
Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.
The Infectious Diseases Society of America recommends the use of daptomycin 6 mg / kg / day in the second-line treatment of IOA on staphylococcal but also enterococcal prostheses, as an alternative to vancomycin and linezolid.
In case of renal failure, daptomycin is often considered as a good therapeutic alternative to glycopeptides.
Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide. Although a large proportion of cases have been reported in patients receiving daptomycin in unapproved indications, the use of daptomycin in authorized indications has also been associated with this risk.
The dosage of daptomycin makes it possible to evaluate its effectiveness and prevent the occurrence of a overdose, provider of side effects.
The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eosinophilic pneumonia on daptomycin | – | Other: Description of eosinophilic pneumonia due to daptomycinepatients having an osteoarticular infection treated with daptomycin and which developped eosinophilic pneumonia |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients having had an eosinophilic pneumonia under daptomycine given to treat an osteoarticular infection (BJI/PJI) treated at the CRIOAc Lyon
Key inclusion criteria (1 listed)
- patients having had an eosinophilic pneumonia under daptomycine given to treat an osteoarticular infection (BJI/PJI)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Description of eosinophilic pneumonia due to daptomycineDescription of eosinophilic pneumonia in patients treated by daptomycin for an osteoarticular infection | Other | Eosinophilic pneumonia on daptomycin |
Primary outcome
description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin
Time frame: 2 months
description of the BJI/PJI (symptoms, type of evolution, type of implant)
description patients having eosinophilic pneumonia due to daptomycin
Time frame: 2 months
description of the patients (average age, medical background)
rate of eosinophilic pneumonia due to daptomycin in osteoarticular infection: the adverse event
Time frame: 6 months
number of cases and description of the adverse event as assessed by CTCAE v4.0
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine
Time frame: 6 months
description of the use of daptomycine : dosage
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine
Time frame: 6 months
description of the use of daptomycine : duration
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance
Time frame: 6 months
mean daptomycine plasma clearance (unit, liters per hour)
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution
Time frame: 6 months
mean daptomycine volume of distribution (unit, liters)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
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 Dactinomycin Adverse Reaction and Bone and Joint Infection, run by Hospices Civils de Lyon 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 1 inclusion and 1 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 9 Nov 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 Eugénie Mabrut, CRA (04 26 73 29 38, eugenie.mabrut@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin (time frame: 2 months). The study lists 7 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 9 Nov 2020.