Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

Bone and Joint Infection Clinical Trial

— PKTOXDAP  

Official title:

Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933344
• Other study ID #: 397
• Status: Recruiting
• Start date: June 15, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2022
• Source: Hospices Civils de Lyon
• Contact: Tristan Ferry, Md,PhD
• Phone: 04 26 73 29 38
• Email: tristan.ferry[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1130
• Est. completion date: July 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who objected to participating in the study

• Absence of blood dosage of daptomycin

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Dactinomycin Adverse Reaction
• Infections

Intervention

Other:
• patients 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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of patients having had a PJI or BJI treated by daptomycin	proportion of patients treated by daptomycin	between 2010 and 2020
Primary	description of BJI/PJI	type of BJI or PJI	between 2010 and 2020
Primary	description of patients	comorbidites	between 2010 and 2020
Primary	description of adverse event	type of adverse event	between 2010 and 2020
Primary	rate of patients having had an adverse event	proportion of patients having had an adverse event under daptomycin	between 2010 and 2020
Primary	Evalutation of the adverse event due to daptomycin : dosage of daptomycine	description of the use of daptomycine : dosage	between 2010 and 2020
Primary	Evalutation of the adverse event due to daptomycin : duration of daptomycine	description of the use of daptomycine : duration	between 2010 and 2020
Primary	Evalutation of the adverse event due to daptomycin : daptomycine plasma clearance	mean daptomycine plasma clearance (unit, liters per hour)	between 2010 and 2020
Primary	Evalutation of the adverse event due to daptomycin : daptomycine volume distribution	mean daptomycine volume of distribution (unit, liters)	between 2010 and 2020

External Links

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