An interventional study of Dalbavancin in Osteoarticular Infection, sponsored by Centre Hospitalier Universitaire de Nice. Active, not recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment
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.
Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
Hepatic cirrhosis
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.
Drug: Dalbavancin
The unit dose of dalbavancin administered via the peripheral venous route will be 1500 mg at each injection with a first injection at Day1, a second injection at Day15 and a third at Day36, which corresponds to 61 days of treatment with dalbavancin. In case of residual dalbavancin dosage at Day15 lower than 15 mg/L (rare situation) and a minimal inhibitory concentration for dalbavancin of 0.125mg/L (less than 5% of the strains), an injection every 14 days will be necessary, i.e. Day1, Day15, Day29, Day43 and Day57, which corresponds to 71 days of dalbavancin treatment. Rifampicin should be given orally at a dose of 600 mg on an empty stomach in the morning for patients weighing less than 70 kg and 900 mg on an empty stomach in the morning for patients weighing more than 70 kg.
therapeutic success
therapeutic success defined by the absence of failure within 12 months of surgical management
Time frame: 12 months
therapeutic success at 24 months
therapeutic success defined by the absence of failure within 24 months of surgical management
Time frame: 24 months
Tolerance
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.
Time frame: 6 months of first administration of dalbavancin
Residual dalbavancin dosage
Residual dalbavancin dosage at Day61
Time frame: Day 61 of first administration of dalbavancin
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice