Efficacy of dalbavancin in osteoarticular infections associated with hip, knee and shoulder prostheses PRO-DALBA

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

7 Mar 2022 → ongoing

Decision date (initial)

2024-10-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518183-12-00

EudraCT number

2020-003169-20

ClinicalTrials.gov

NCT05046860

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To describe the efficacy of dalbavancin in combination with rifampicin during the treatment of staphylococcal HAIs associated with hip, knee and shoulder prostheses 12 months after surgical management.

Secondary objectives 4

1. To describe the efficacy of dalbavancin in combination with rifampicin in the treatment of staphylococcal HAIs associated with hip, knee and shoulder prostheses 24 months after surgical management.
2. Tolerance of dalbavancin in the 6 months following administration
3. Study of the association between residual dalbavancin dosage at the end of treatment and clinical outcome at 12 and 24 months
4. Signature of informed consent

Conditions and MedDRA coding

prosthetic joint infections

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age > or = 18 year old
2. Prosthetic joint infections of knee prosthesis, total hip prosthesis, intermediate hip prosthesis or total shoulder prosthesis (inverted or anatomical) monomicrobial with staphylococcus sensitive to dalbavancin (determined by MIC by microdilution of the strain in question for vancomycin < or = 2mg/L) and rifampicin, surgically treated with DAIR with or without changing moving parts (acute infections) or 1-stage or 2-stage change (chronic infections)
3. Social security affiliation

Exclusion criteria 13

1. Hypersensitivity to glycopeptides or rifampicin or to any of the excipients
2. Porphyria
3. probabilistic antibiotic treatment not administered within 24 hours of surgery
4. Probabilistic antibiotic treatment that does not take into account the bacterium causing the infection in its spectrum.
5. Acute blood-borne infection (acute secondary infection)
6. Use of background therapy incompatible with the inductive effect of rifampin (see rifampin SmPC).
7. Contraindications to rifampin therapy: Moderate to severe impairment of liver function, patients with a history of hypersensitivity to other rifamycins, porphyria.
8. Cirrhosis of the liver
9. Taking ototoxic treatments, such as aminoglycosides
10. Fonction rénale avec un débit de filtration glomérulaire mesuré par COCKROFT inférieur à 30 ml/min
11. Pregnant and breast-feeding 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.
12. Women of childbearing age not using an effective method of contraception (pill, intrauterine device, vaginal ring, contraceptive skin patch, hormonal subcutaneous implant, surgical sterilization).
13. Protected persons as defined in articles of the French Public Health Code.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Success is defined as the absence of failure within 12 months of surgical management.

Secondary endpoints 3

1. Success is defined as the absence of failure within 24 months of surgical management.
2. Tolerability will be assessed by collecting adverse events during treatment with dalbavancin and rifampicin classified according to CTCAE (version 5.0) within 6 months of first administration.
3. Residual dose of dalbavancin at D61

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

4 Avenue Reine Victoria

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Johan COURJON

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Maeva GODEMERT

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications