Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209934
Other study ID # 69HCL17_0465
Secondary ID
Status Completed
Phase N/A
First received July 4, 2017
Last updated July 4, 2017
Start date July 2014
Est. completion date January 2015

Study information

Verified date July 2017
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The choice of antimicrobial therapy to treat complex bone and joint infections (BJI) is challenging, requiring consideration of: (i) the problem of bone diffusion; (ii) the necessity of using antimicrobials active against bacterial biofilms; (iii) the growing incidence of antibiotic resistance; and (iv) the high risk of severe adverse events (SAE) in response to first-line antimicrobials in these patients.

Consequently, off-label use of recently developed antimicrobials, such as daptomycin, is frequently required as salvage therapy in complex BJI. Even if daptomycin does not have approval for the treatment of BJI, the Infectious Diseases Society of America guidelines propose this antibiotic as alternative therapy for prosthetic joint infection. The recommended dose is 6 mg/kg/d, whereas recent data support the use of higher doses in these patients as bone penetration of daptomycin is limited.

The present cohort study aimed to assess the safety and efficacy of prolonged high-dose (>6 mg/kg/d) daptomycin salvage therapy in patients with complex BJI.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients having BJI treated by daptomycin at >6 mg/kg/d

Exclusion Criteria:

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of daptomycin through plasma concentration (Cmin) The approximal maximal treatment duration is 300 days. Daptomycin trough plasma concentration (Cmin) is determined monthly to detect any patients with daptomycin trough levels (Cmin) over 24 mg/L. Cmin is determined 24 h after daptomycin injection (just before reinjection, if performed) using a validated HPLC process developed in the laboratory and a diode array UV detector.
Cmin > 24 mg/L was considered an overdose, as the risk of high CPK levels (with or without symptoms of myopathy) is greater above this threshold
300 days
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 NCT04933344 - Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections
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
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