LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection

NCT00906048 | Terminated Phase 3

• 2 other identifiers: LEVOF_L_038152008-003284-39(EudraCT)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is: to assess the microbiological success of the combination of levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the prosthesis. The secondary endpoints are:

• To assess the rate of clinical failure 12 months after the reimplantation of the prosthesis.
• To assess the joint mobility function score 12 months after the reimplantation of the prosthesis.
• To assess the safety of the combination of levofloxacin and rifampicin.
• To investigate prognostic factors for success after the end of treatment and at 12 months after the reimplantation of the prosthesis.

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

• Microbiological success defined as the percentage of patients with negative peri-operative bacteriological samples and the absence of clinical, biological or radiological signs of infection.

  During the reimplantation of the new prosthesis i.e. 15 days to 3 months after the end of treatment

Secondary Outcomes (2)

• Clinical failure

  12 months after reimplantation of the prosthesis

• Joint mobility function score

  12 months after reimplantation of the prosthesis

Study Arms (1)

1

EXPERIMENTAL

Levofloxacin and Rifampicin

Drug: Levofloxacin (HR355) and Rifampicin Therapy

Interventions

Levofloxacin (HR355) and Rifampicin Therapy DRUG

Film-coated scored tablet measured at 500 mg of levofloxacin and capsule at 300 mg of rifampicin per os once a day Weight \< 70 kg: 1 tablet of levofloxacin and 2 capsules of rifampicin Weight \> 70 kg: 1 tablet of levofloxacin and 3 capsules of rifampicin

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarticular prosthetic bacterial infection (hip or knee)
• Documented microbiological infection due to Staphylococcus aureus and/or coagulase-negative staphylococci, susceptible to fluoroquinolones and to rifampicin with:
• For Staphylococcus aureus, a minimum of 2 positive perioperative samples is required.
• For the coagulase-negative staphylococci, a minimum of 3 positive perioperative samples is required. In the event of combination, there is a minimum of 2 positive perioperative samples for Staphylococcus aureus and a minimum of 3 positive perioperative samples for coagulase-negative staphylococci.
• Two-stage surgical management with: during the first operative stage: removal of the prosthesis, large debridement, implantation or not of a spacer during the second operative stage: implantation of a new cemented prosthesis or not (If possible, without antibiotics as recommended by Sofcot (25), otherwise containing gentamicin).
• Negative urine pregnancy test for females of child-bearing age.
• A barrier contraception method throughout the duration of treatment and for the 4 weeks following the discontinuation of rifampicin for females of child-bearing age.

You may not qualify if:

• Osteoarticular prosthetic infection at more than one site.
• Osteoarticular prosthetic infection without bacteriological documentation.
• Infection due to staphylococci that are not susceptible to fluoroquinolones or rifampicin.
• Infection not due to staphylococci.
• Absence of surgical management.
• More than 2 surgical repeats due to infection at the infected site.
• Renal impairment with creatinine clearance \< 50 ml/min.
• Hepatic impairment.
• Hypersensitivity to levofloxacin, to a product in the quinolone class, to rifamycins or to the excipients of the study products.
• A history of tendinopathy associated with a fluoroquinolone.
• Glucose-6-phosphate dehydrogenase deficiency.
• History of convulsions or epilepsy predisposing factors for the occurrence of convulsions.
• Porphyria.
• Combination use with protease inhibitors or with delavirdine or nevirapine.
• Estrogen-progestin and progestin contraceptives.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Paris, France

Location

MeSH Terms

Conditions

Infections

Interventions

Levofloxacin

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nathalie Billon

  sanofi-aventis administrative office

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 7, 2011

Record last verified: 2011-02

Locations

FR (1)