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

NCT ID: NCT05046860

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2024-09-30

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.

Conditions

Osteoarticular Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dalbavancine + Rifampicine

Group Type: EXPERIMENTAL

Dalbavancin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélien DINH, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HP - Hôpital Ambroise-Paré

Eric SENNEVILLE, PD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Tourcoing

Locations

AP-HP - Hôpital Ambroise-Paré

Boulogne-Billancourt, , France

Site Status: RECRUITING

CHU de Nice

Nice, , France

Site Status: RECRUITING

Centre Hospitalier de Tourcoing

Tourcoing, , France

Site Status: RECRUITING

CHRU de TOURS

Tours, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Johan COURJON, MD

Role: CONTACT

courjon.j@chu-nice.fr

0492035452 ext. +33

Facility Contacts

Aurélien DINH

Role: primary

aurelien.dinh@aphp.fr

Johan Courjon, MD

Role: primary

Eric SENNEVILLE

Role: primary

Role: backup

esenneville@ch-tourcoing.fr

Adrien LEMAIGNEN

Role: primary

adrien.lemaignen@univ-tours.fr

Other Identifiers

20-AOI-03

Identifier Type: -

Identifier Source: org_study_id