Using Dalbavancin to treat infections in hip and knee replacements

Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements

This study is testing if Dalbavancin, a long-lasting antibiotic, can effectively treat infections in people with hip and knee replacements caused by a specific type of bacteria.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Locations: 4 sites (Boulogne-Billancourt and 3 other locations)
• Trial ID: NCT05046860 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Dalbavancin, a long-acting antibiotic, in treating osteoarticular infections associated with hip and knee prostheses. The trial focuses on patients with a first monomicrobial infection caused by staphylococcus that is sensitive to Dalbavancin. Participants will receive Dalbavancin after surgical management, which includes debridement and implant retention. The study aims to provide a clearer understanding of Dalbavancin's efficacy in a specific patient population and infection type.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a first monomicrobial osteoarticular infection of a knee or hip prosthesis caused by a staphylococcus strain sensitive to Dalbavancin.

Not a fit: Patients with hypersensitivity to glycopeptides or rifampicin, or those with acute hematogenous infections, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve recovery outcomes for patients with infections related to hip and knee prostheses.

How similar studies have performed: While there is limited literature on Dalbavancin's efficacy for this specific condition, similar antibiotic approaches have shown promise in treating other infections.

Eligibility criteria

Inclusion Criteria:

* Age greater than or equal to 18 years
* First monomicrobial osteoarticular infection of knee or hip prosthesis with staphylococcus sensitive to dalbavancin (determined by a minimum inhibitory concentration by microdilution of the strain in question for vancomycin less than or equal to 2mg/L) and rifampicin, treated surgically by debridement, antibiotics and implant retention with change of moving parts (acute infections) or change in 1 stage (chronic infections)
* Social security affiliation
* Signature of informed consent

Exclusion Criteria:

* Hypersensitivity to glycopeptides or rifampin or to any of the excipients
* Porphyrias
* Probabilistic antibiotic treatment not administered within 24 hours of surgery
* Probabilistic antibiotic treatment that did not take into account the bacterium causing the infection in its spectrum
* Acute hematogenous infection (acute secondary)
* Use of background treatment incompatible with the inducing effect of rifampicin (see Summary of Product Characteristics for rifampicin)
* Contraindications to rifampin therapy: Moderate to severe impairment of liver function, patients with a history of hypersensitivity to other rifamycins, porphyria.

Hepatic cirrhosis

* Use of ototoxic therapy, such as an aminoglycoside
* Renal function with glomerular filtration rate less than 30 ml/min as measured by MDRD (Modification of Diet in Renal Disease)
* Pregnant and breastfeeding women: at inclusion a blood pregnancy test will be performed for women of childbearing age. The results will be communicated to the patient by a physician of her choice.
* Women of childbearing age not using an effective method of contraception (pill, intrauterine device, vaginal ring, contraceptive skin patch, hormonal subcutaneous implant, surgical sterilization)
* Protected persons defined in the following articles of the public health code:

L. 1121-6: persons deprived of liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than research; L. 1121-8: adults subject to a legal protection measure or unable to express their consent; L. 1122-1-2: persons in emergency situations who are unable to give prior consent.

Where this trial is running

Boulogne-Billancourt and 3 other locations

• AP-HP - Hôpital Ambroise-Paré — Boulogne-Billancourt, France (Recruiting)
• CHU de Nice — Nice, France (Recruiting)
• Centre Hospitalier de Tourcoing — Tourcoing, France (Recruiting)
• CHRU de TOURS — Tours, France (Recruiting)

Study contacts

• Principal investigator: Aurélien DINH, MD — AP-HP - Hôpital Ambroise-Paré
• Study coordinator: Johan COURJON, MD

Conditions Osteoarticular Infection; hip prosthese; knee prosthese