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

Not Applicable

Recruiting

• Conditions: Osteoarticular Infection
• Interventions: Drug: Dalbavancin

• Registration Number: NCT05046860
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Osteoarticular infections associated with hip and knee prostheses require optimal surgical and medical management to maximize the rate of therapeutic success. Antibiotic therapy should be administered for a period of 12 weeks. Tolerance problems, difficulties in maintaining compliance over 12 weeks, bacterial multidrug resistance and sometimes intravenous administration are the main obstacles to appropriate antibiotic therapy and to limiting iatrogenicity. Dalbavancin is an antibiotic derived from teicoplanin (glycopeptide) with a long half-life, of punctual parenteral administration without a central line, active on staphylococci, and well tolerated. The data in the literature concerning its efficacy in Osteoarticular infections associated with hip and knee prostheses are limited and heterogeneous. Investigators would like to describe its efficacy in a homogeneous series of patients in terms of the type of infection, their surgical management and the methods of administration of the product in order to extend its use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-16
• Study Start: 2022-03-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dalbavancine + Rifampicine	Dalbavancin	-

Primary Outcome Measures

Name	Time	Method
therapeutic success	12 months	therapeutic success defined by the absence of failure within 12 months of surgical management

Secondary Outcome Measures

Name	Time	Method
Tolerance	6 months of first administration of dalbavancin	Tolerance will be assessed by collecting adverse events during treatment with dalbavancin and rifampin classified according to Common Terminology Criteria for Adverse Events (version 5.0) within 6 months of its first administration.
Residual dalbavancin dosage	Day 61 of first administration of dalbavancin	Residual dalbavancin dosage at Day61
therapeutic success at 24 months	24 months	therapeutic success defined by the absence of failure within 24 months of surgical management

Trial Locations

Locations (4)

CHRU de TOURS; 🇫🇷 Tours, France

AP-HP - Hôpital Ambroise-Paré; 🇫🇷 Boulogne-Billancourt, France

Centre Hospitalier de Tourcoing; 🇫🇷 Tourcoing, France

CHU de Nice; 🇫🇷 Nice, France