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

NCT05046860 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-03-13

No results posted yet for this 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.

Conditions

  • Osteoarticular Infection

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Aurélien DINH, MD · AP-HP - Hôpital Ambroise-Paré

  • Eric SENNEVILLE, PD · Centre Hospitalier de Tourcoing

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046860 on ClinicalTrials.gov