Clindamycin as Antimicrobial Treatment for Streptococcus... | NCT07335627

Studies
Clindamycin as Antimicrobial Treatment for Streptococcus Spp. PeRiprosthetic Infection

NCT07335627

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Jan 13, 2026Actual

Enrollment

260Estimated

Phase

Not provided

Conditions

Streptococcus Infection

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2025Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 21, 2026Estimated

First Submitted Date

Jan 2, 2026

First Submission Date that Met QC Criteria

Jan 2, 2026

First Posted Date

Jan 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2026

Last Update Posted Date

Jan 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Therapeutic success of the medical-surgical strategy	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

- Adult patient at the time of surgery for infection with a probable or proven periprosthetic infection with Streptococcus spp. according to EBJIS diagnostic criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stéphane KLEIN, MD	Contact	33 3 68 76 52 32		stephane.klein@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D013290	Streptococcal Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided