- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07335627
Clindamycin as Antimicrobial Treatment for Streptococcus Spp. PeRiprosthetic Infection (CASPR)
Clindamycin is an antibiotic with several advantages: high oral bioavailability and good bone and joint penetration. In France, it is a recommended drug for other types of Streptococcus spp. osteoarticular infections and can be used as an alternative to amoxicillin for periprosthetic infections, including when implants are retained.
The hypothesis of this study is that clindamycin is no less effective than other drugs commonly used to treat periprosthetic Streptococcus spp. infections.
The primary objective of this study is to evaluate the success rate of Streptococcus spp. periprosthetic joint infections treated with clindamycin compared to other antibiotic treatments.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stéphane KLEIN, MD
- Phone Number: 33 3 68 76 52 32
- Email: stephane.klein@chru-strasbourg.fr
Study Locations
-
-
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Strasbourg, France, 67091
- Recruiting
- Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
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Principal Investigator:
- Martin MARTINOT, MD
-
Sub-Investigator:
- Julien GODET, Statistician
-
Contact:
- Stéphane KLEIN, MD
- Phone Number: 33 3 68 76 52 32
- Email: stephane.klein@chru-strasbourg.fr
-
Principal Investigator:
- Stéphane KLEIN, MD
-
Sub-Investigator:
- Cécile ROND-OUSTAU, MD
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Principal Investigator:
- Aurélie BALDOLI, MD
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Principal Investigator:
- Clément THEIS, MD
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Principal Investigator:
- Kevin BOUILLER, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patient (aged 18 years or older) at the time of surgery for infection
- Probable or proven periprosthetic infection with Streptococcus spp. according to EBJIS diagnostic criteria
- Patient operated on in one of the associated centers between 2013 and 2024
Exclusion Criteria:
- Patient who underwent joint resection or amputation
- Patient who was treated with suppressive antibiotic therapy (defined as antibiotic treatment lasting more than 6 months) which was decided upon prior to surgery
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Therapeutic success of the medical-surgical strategy
Time Frame: One year after the end of antibiotic treatment
|
Therapeutic success of the medical-surgical strategy defined as: patient showing no clinical signs of infection, no need for repeat surgery one year after the end of antibiotic treatment, and no repeat antibiotic treatment.
|
One year after the end of antibiotic treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9536
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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