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
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
FranceActive - Recruiting
CHU de Nice
Nice,
FranceActive - Recruiting
Centre Hospitalier de Tourcoing
Tourcoing, 59208
FranceActive - Recruiting
CHRU de TOURS
Tours, 37000
FranceActive - Recruiting
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