Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04933344
Other study ID # 397
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05421312 - Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip Phase 4
Active, not recruiting NCT04563325 - Oral-only Antibiotics for Bone and Joint Infections in Children Phase 4
Completed NCT03627000 - Microbiological Epidemiology in Patients Experiencing Microbiological or Clinical Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
Completed NCT03311113 - Adherence to Oral Antibiotics In Patients With Osteoarticular Infections
Recruiting NCT05753215 - Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection Phase 2
Completed NCT03209921 - Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections N/A
Completed NCT04418882 - Septic Management and Outcome of Open Fracture
Completed NCT05248490 - Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home N/A
Completed NCT03624855 - Implant-Associated P. Aeruginosa Bone And Joint Infections : Experience In A Regional Reference Center In France
Recruiting NCT04496024 - Ofloxacin Concentration-toxicity Relationship in the Elderly N/A
Recruiting NCT04538053 - BonE and Joint Infections - Simplifying Treatment in Children Trial Phase 4
Completed NCT04373278 - Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study
Completed NCT03209934 - Daptomycin > 6 mg/kg/Day as Salvage Therapy in Patients With Complex Bone and Joint Infection: Cohort Study in a Regionalreference Center N/A
Recruiting NCT02817711 - Lyon BJI Cohort Study N/A
Recruiting NCT03611634 - Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine
Completed NCT03177369 - Teicoplanin-based Antimicrobial Therapy in Staphylococcus Aureus Bone and Joint Infection: Tolerance, Efficacy and Experience With Subcutaneous Administration N/A
Recruiting NCT04722926 - Lyon PJI Retrospective Cohort Study
Completed NCT03852784 - Osteoarticular Infections With Pneumococcal
Recruiting NCT03796104 - Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR
Completed NCT03848104 - Evaluation of the Use of Cefoxitin in Combination in Continuous Parenteral Administration in the Treatment of Bone and Joint Infections

External Links