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

Centre Hospitalier Universitaire de Nice

Status

Enrolling

Conditions

Osteoarticular Infection

Treatments

Drug: Dalbavancin

Study type

Interventional

Funder types

Other

Identifiers

NCT05046860

20-AOI-03

Details and patient eligibility

About

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.

Enrollment

43 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.