Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus (CISTA)

NCT04946500 | Unknown

• 1 other identifier: CISTA - 29BRC21.0123
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The alternatives to the combination of Fluoroquinolone and Rifampicin in prosthetic joint infections (PJI) caused by staphylococcus are currently unclear. Clindamycin is prescribed as dual therapy in this indication, and provides many advantages. We conducted a multicenter retrospective observational study evaluating the efficacy and safety of Clindamycin in prosthetic joint infections due to staphylococcus between January 2013 and December 2019.

Conditions

Prosthetic Joint Infection; Staphylococcus

Outcome Measures

Primary Outcomes (1)

• Failure of Clindamycine

  New diagnosis of PJI at the same site, caused by the same microbial agent

  within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)

Secondary Outcomes (2)

• Safety of Clindamycin

  During the treatment and 6 month after

• Correlation between failure of Clindamycin and blood level of Clindamycin

  within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)

Study Arms (2)

Clindamycin and Rifampicin

Patients treated with Clindamycin and Rifampicin

Clindamycin and Fluoroquinolone

Patients treated with Clindamycin and Fluoroquinolone

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Prosthetic Joint Infections caused by Staphylococccus treated with Clindamycin

You may qualify if:

• Patients with PJI defined according to the IDSA.
• Infection must be mono-microbial or multi-microbial with Staphylococcus spp sensitive to Clindamycin.
• Infection may be acute or chronic, nosocomial or community-acquired.
• Patient having received a curative treatment with Clindamycin.

You may not qualify if:

• Patients with osteitis, osteomyelitis, septic arthritis in native joints, diabetic foot infections, spondylodiscitis, infections in external fixator, surgical site infections following neurosurgical management, bedsores, skin and soft tissue infections.
• Patients with mono-microbial infections other than Staphylococcus, multi-microbial infections including other bacteria than Staphylococcus, suspected Osteoarticular Infection without microbial identification.
• Patients with clindamycin-resistant Staphylococcal PJI, constitutive MLSb phenotype.
• Patients having received suspensive treatment with Clindamycin.
• Patients treated with Clindamycin as last line of treatment for a duration of less than 14 days.
• Patients refusing to participate
• Patients under legal protection (guardianship, curatorship, ..)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de Brest

Brest, 29609, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: July 1, 2021
• Study Start: May 15, 2021
• Primary Completion: July 15, 2021
• Study Completion: October 15, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three month and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)