CClinicalTrials.gg
Status unknownNCT04933344PKTOXDAPUpdated May 6, 2022

Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

An observational study in Dactinomycin Adverse Reaction and Bone and Joint Infection, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-06.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,130
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dactinomycin Adverse Reaction
  • Bone and Joint Infection

Keywords

  • bone and joint infection
  • adverse event
  • daptomycin
  • Eosinophilic pneumonia
  • CPK
  • rhabdomyolysis
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 1,130 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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

Inclusion criteria

  • Patients who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed

Exclusion criteria

Exclusion Criteria:

  • Patients who objected to participating in the study
  • Absence of blood dosage of daptomycin
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,130 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Other: patients having had BJI or PJI treated with daptomycin

Interventions

  • Otherpatients having had BJI or PJI treated with daptomycin

    patients having had BJI or PJI treated with daptomycin who developped an adverse event : eosinophilic pneumonia and/or elevation of CPK

06

What researchers measure

Primary outcomes

  1. rate of patients having had a PJI or BJI treated by daptomycin

    proportion of patients treated by daptomycin

    Time frame: between 2010 and 2020

  2. description of BJI/PJI

    type of BJI or PJI

    Time frame: between 2010 and 2020

  3. description of patients

    comorbidites

    Time frame: between 2010 and 2020

  4. description of adverse event

    type of adverse event

    Time frame: between 2010 and 2020

  5. rate of patients having had an adverse event

    proportion of patients having had an adverse event under daptomycin

    Time frame: between 2010 and 2020

  6. Evalutation of the adverse event due to daptomycin : dosage of daptomycine

    description of the use of daptomycine : dosage

    Time frame: between 2010 and 2020

  7. Evalutation of the adverse event due to daptomycin : duration of daptomycine

    description of the use of daptomycine : duration

    Time frame: between 2010 and 2020

  8. Evalutation of the adverse event due to daptomycin : daptomycine plasma clearance

    mean daptomycine plasma clearance (unit, liters per hour)

    Time frame: between 2010 and 2020

  9. Evalutation of the adverse event due to daptomycin : daptomycine volume distribution

    mean daptomycine volume of distribution (unit, liters)

    Time frame: between 2010 and 2020

07

Study locations

1 of 1 sites recruiting
  • Hospices Civils de Lyon
    Lyon, 69004, France
    Recruiting
08

References and documents

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04933344
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jun 21, 2021
Start date
Jun 15, 2021
Primary completion
Mar 1, 2022
Completion
Jul 1, 2022 (estimated)
Last update
May 6, 2022

Study contacts

Tristan Ferry, Md,PhD
Contact
tristan.ferry@chu-lyon.fr
04 26 73 29 38
Eugenie Mabrut, CRA
Contact
eugenie.mabrut@chu-lyon.fr
04 26 73 29 38

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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