Dactinomycin Adverse ReactionPKTOXDAPNCT04933344
Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections
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
the aim of this study is to investigate the relationship between exposure to daptomycin and the occurrence of muscle toxicity or eosinophilic pneumonia in patients treated with daptomycin for bone and joint infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dactinomycin Adverse Reaction, Bone and Joint Infection
- What is being tested?
- patients having had BJI or PJI treated with daptomycin
- How many people
- 1,130 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to 1 Jul 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients managed at the CRIOAc Lyon who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed
Who may be able to join
- Patients who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed
Who cannot join
- Patients who objected to participating in the study
- Absence of blood dosage of daptomycin
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA, 04 26 73 29 38, eugenie.mabrut@chu-lyon.fr
About this study
the aim of this study is to investigate the relationship between exposure to daptomycin and the occurrence of muscle toxicity or eosinophilic pneumonia in patients treated with daptomycin for bone and joint infection
Read the detailed description
Daptomycin is widely used in osteoarticular infections (IOA), as an alternative to vancomycin, and recommended for this use by various learned societies including the Infectious Diseases Society of America (IDSA) in 2013.
Tolerance to daptomycin is generally favorable, with in particular better renal tolerance than vancomycin. However, two rare and potentially severe side effects have been described with this antibiotics: muscle toxicity and eosinophilic pneumonia.
- Being tested
- patients having had BJI or PJI treated with daptomycin
- Keywords
- bone and joint infection, adverse event, daptomycin, Eosinophilic pneumonia, CPK, rhabdomyolysis
- Medical subject headings
- Pulmonary Eosinophilia, Rhabdomyolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients having had BJI or PJI treated with daptomycinOther
patients having had BJI or PJI treated with daptomycin who developped an adverse event : eosinophilic pneumonia and/or elevation of CPK
| Study group | Role | What they receive |
|---|---|---|
| patients having had BJI or PJI treated with daptomycin | patients having an osteoarticular infection treated with daptomycin and which developped eosinophilic pneumonia or elevation of CPK Receives: Other: patients having had BJI or PJI treated with daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients having had a PJI or BJI treated by daptomycin
proportion of patients treated by daptomycin
Measured: between 2010 and 2020
description of BJI/PJI
type of BJI or PJI
Measured: between 2010 and 2020
description of patients
comorbidites
Measured: between 2010 and 2020
description of adverse event
type of adverse event
Measured: between 2010 and 2020
rate of patients having had an adverse event
proportion of patients having had an adverse event under daptomycin
Measured: between 2010 and 2020
Evalutation of the adverse event due to daptomycin : dosage of daptomycine
description of the use of daptomycine : dosage
Measured: between 2010 and 2020
Evalutation of the adverse event due to daptomycin : duration of daptomycine
description of the use of daptomycine : duration
Measured: between 2010 and 2020
Evalutation of the adverse event due to daptomycin : daptomycine plasma clearance
mean daptomycine plasma clearance (unit, liters per hour)
Measured: between 2010 and 2020
Evalutation of the adverse event due to daptomycin : daptomycine volume distribution
mean daptomycine volume of distribution (unit, liters)
Measured: between 2010 and 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start15 Jun 2021
- Primary completion1 Mar 2022
- Study completion1 Jul 2022 (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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,130 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
- NCT04933344
- Sponsor's protocol ID
- 397
- Acronym
- PKTOXDAP
- Status last verified
- May 2022
- First submitted
- 15 Jun 2021
- Last updated
- 6 May 2022
- 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 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections
- ClinicalTrials.gov ID
- NCT04933344
- Acronym / sponsor ID
- PKTOXDAP / 397
- Keywords
- bone and joint infection, adverse event, daptomycin, Eosinophilic pneumonia, CPK, rhabdomyolysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,130 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 21 Jun 2021 (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.
the aim of this study is to investigate the relationship between exposure to daptomycin and the occurrence of muscle toxicity or eosinophilic pneumonia in patients treated with daptomycin for bone and joint infection
Detailed description
Daptomycin is widely used in osteoarticular infections (IOA), as an alternative to vancomycin, and recommended for this use by various learned societies including the Infectious Diseases Society of America (IDSA) in 2013.
Tolerance to daptomycin is generally favorable, with in particular better renal tolerance than vancomycin. However, two rare and potentially severe side effects have been described with this antibiotics: muscle toxicity and eosinophilic pneumonia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients having had BJI or PJI treated with daptomycin | – | Other: patients having had BJI or PJI treated with daptomycinpatients having an osteoarticular infection treated with daptomycin and which developped eosinophilic pneumonia or elevation of CPK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients managed at the CRIOAc Lyon who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed
Key inclusion criteria (1 listed)
- Patients who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed
Key exclusion criteria (2 listed)
- Patients who objected to participating in the study
- Absence of blood dosage of daptomycin
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 |
|---|---|---|
| patients having had BJI or PJI treated with daptomycinpatients having had BJI or PJI treated with daptomycin who developped an adverse event : eosinophilic pneumonia and/or elevation of CPK | Other | patients having had BJI or PJI treated with daptomycin |
Primary outcome
rate of patients having had a PJI or BJI treated by daptomycin
Time frame: between 2010 and 2020
proportion of patients treated by daptomycin
description of BJI/PJI
Time frame: between 2010 and 2020
type of BJI or PJI
description of patients
Time frame: between 2010 and 2020
comorbidites
description of adverse event
Time frame: between 2010 and 2020
type of adverse event
rate of patients having had an adverse event
Time frame: between 2010 and 2020
proportion of patients having had an adverse event under daptomycin
Evalutation of the adverse event due to daptomycin : dosage of daptomycine
Time frame: between 2010 and 2020
description of the use of daptomycine : dosage
Evalutation of the adverse event due to daptomycin : duration of daptomycine
Time frame: between 2010 and 2020
description of the use of daptomycine : duration
Evalutation of the adverse event due to daptomycin : daptomycine plasma clearance
Time frame: between 2010 and 2020
mean daptomycine plasma clearance (unit, liters per hour)
Evalutation of the adverse event due to daptomycin : daptomycine volume distribution
Time frame: between 2010 and 2020
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 6 May 2022.
- 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 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 6 May 2022. 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 Tristan Ferry, Md,PhD (04 26 73 29 38, tristan.ferry@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of patients having had a PJI or BJI treated by daptomycin (time frame: between 2010 and 2020). The study lists 9 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 6 May 2022.