Prosthetic Joint InfectionCISTANCT04946500
Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus (CISTA)
An observational study of Prosthetic Joint Infection and Staphylococcus, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthetic Joint Infection, Staphylococcus
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2021to 15 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Prosthetic Joint Infections caused by Staphylococccus treated with Clindamycin
Who may be able to join
- 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.
Who cannot join
- 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, ..)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prosthetic Joint Infection, Staphylococcus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin and Rifampicin | Patients treated with Clindamycin and Rifampicin | |
| Clindamycin and Fluoroquinolone | Patients treated with Clindamycin and Fluoroquinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of Clindamycine
New diagnosis of PJI at the same site, caused by the same microbial agent
Measured: within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)
Secondary outcomes (2)
Safety of Clindamycin
Safety of Clindamycin in the treatment of PJI
Measured: During the treatment and 6 month after
Correlation between failure of Clindamycin and blood level of Clindamycin
Measured: within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start15 May 2021
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946500
- Sponsor's protocol ID
- CISTA - 29BRC21.0123
- Acronym
- CISTA
- Status last verified
- Apr 2021
- First submitted
- 6 May 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus
- ClinicalTrials.gov ID
- NCT04946500
- Acronym / sponsor ID
- CISTA / CISTA - 29BRC21.0123
- Conditions
- Prosthetic Joint Infection, Staphylococcus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clindamycin and Rifampicin | – | –Patients treated with Clindamycin and Rifampicin |
| Clindamycin and Fluoroquinolone | – | –Patients treated with Clindamycin and Fluoroquinolone |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Prosthetic Joint Infections caused by Staphylococccus treated with Clindamycin
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure of Clindamycine
Time frame: 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
2 secondary outcomes
Safety of Clindamycin
Time frame: During the treatment and 6 month after
Correlation between failure of Clindamycin and blood level of Clindamycin
Time frame: within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic Joint Infection and Staphylococcus, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of Clindamycine (time frame: within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.