Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus (CISTA)

• Conditions: Prosthetic Joint Infection; Staphylococcus

• Registration Number: NCT04946500
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-05-06
• Study Start: 2021-05-15
• Study First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01
• Primary Completion: 2021-07-15
• Study Completion: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

• 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, ..)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure of Clindamycine	within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)	New diagnosis of PJI at the same site, caused by the same microbial agent

Secondary Outcome Measures

Name	Time	Method
Safety of Clindamycin	During the treatment and 6 month after	Safety of Clindamycin in the treatment of PJI
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)

Trial Locations

Locations (1)

CHU de Brest; 🇫🇷 Brest, France