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

Last updated: March 12, 2024
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteomyelitis

Treatment

Dalbavancin

Clinical Study ID

NCT05046860
20-AOI-03
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 bacteriumcausing the infection in its spectrum
  • Acute hematogenous infection (acute secondary)
  • Use of background treatment incompatible with the inducing effect of rifampicin (seeSummary of Product Characteristics for rifampicin)
  • Contraindications to rifampin therapy: Moderate to severe impairment of liverfunction, 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 beperformed for women of childbearing age. The results will be communicated to thepatient 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 subcutaneousimplant, 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, personshospitalized without consent and persons admitted to a health or social establishment forpurposes other than research; L. 1121-8: adults subject to a legal protection measure orunable to express their consent; L. 1122-1-2: persons in emergency situations who areunable to give prior consent.

Study Design

Total Participants: 43
Treatment Group(s): 1
Primary Treatment: Dalbavancin
Phase:
Study Start date:
March 07, 2022
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • AP-HP - Hôpital Ambroise-Paré

    Boulogne-Billancourt, 92100
    France

    Active - Recruiting

  • CHU de Nice

    Nice,
    France

    Active - Recruiting

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208
    France

    Active - Recruiting

  • CHRU de TOURS

    Tours, 37000
    France

    Active - Recruiting

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