Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus (CISTA) (CISTA)

Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prosthetic Joint Infection; Staphylococcus

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Prosthetic Joint Infections caused by Staphylococccus treated with Clindamycin

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Clindamycin and Rifampicin; Patients treated with Clindamycin and Rifampicin
Clindamycin and Fluoroquinolone; Patients treated with Clindamycin and Fluoroquinolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Clindamycin	Safety of Clindamycin in the treatment of PJI	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)

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Anticipated): July 15, 2021
• Study Completion (Anticipated): October 15, 2021

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious
• Other Study ID Numbers: CISTA - 29BRC21.0123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three month and ending five years following the publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No