Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus (CISTA)

Prosthetic Joint Infection Clinical Trial

— CISTA  

Official title:

Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04946500
• Other study ID #: CISTA - 29BRC21.0123
• Status: Active, not recruiting
• Start date: May 15, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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, ..)

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infection
• Prosthetic Joint Infection
• Staphylococcus

Locations

Country	Name	City	State
France	CHU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety of Clindamycin	Safety of Clindamycin in the treatment of PJI	During the treatment and 6 month after
Secondary	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)