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

Primary Purpose

Osteoarticular Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dalbavancin
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarticular Infection focused on measuring hip prosthese, knee prosthese

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AP-HP - Hôpital Ambroise-Paré
  • CHU de Nice
  • Centre Hospitalier de Tourcoing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dalbavancine + Rifampicine

Arm Description

Outcomes

Primary Outcome Measures

therapeutic success
therapeutic success defined by the absence of failure within 12 months of surgical management

Secondary Outcome Measures

therapeutic success at 24 months
therapeutic success defined by the absence of failure within 24 months of surgical management
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.
Residual dalbavancin dosage
Residual dalbavancin dosage at Day61

Full Information

First Posted
September 13, 2021
Last Updated
September 13, 2021
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05046860
Brief Title
Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements
Acronym
PRODALBA
Official Title
Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 29, 2021 (Anticipated)
Primary Completion Date
September 29, 2022 (Anticipated)
Study Completion Date
September 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarticular Infection
Keywords
hip prosthese, knee prosthese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dalbavancine + Rifampicine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dalbavancin
Intervention Description
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.
Primary Outcome Measure Information:
Title
therapeutic success
Description
therapeutic success defined by the absence of failure within 12 months of surgical management
Time Frame
12 months
Secondary Outcome Measure Information:
Title
therapeutic success at 24 months
Description
therapeutic success defined by the absence of failure within 24 months of surgical management
Time Frame
24 months
Title
Tolerance
Description
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
Title
Residual dalbavancin dosage
Description
Residual dalbavancin dosage at Day61
Time Frame
Day 61 of first administration of dalbavancin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan COURJON, MD
Phone
0492035452
Ext
+33
Email
courjon.j@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélien DINH, MD
Organizational Affiliation
AP-HP - Hôpital Ambroise-Paré
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric SENNEVILLE, PD
Organizational Affiliation
Centre Hospitalier de Tourcoing
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP - Hôpital Ambroise-Paré
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélien DINH
Email
aurelien.dinh@aphp.fr
Facility Name
CHU de Nice
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Courjon, MD
Facility Name
Centre Hospitalier de Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric SENNEVILLE
Email
esenneville@ch-tourcoing.fr

12. IPD Sharing Statement

Learn more about this trial

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

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