Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(lack of recruitment)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00906048
First received: May 20, 2009
Last updated: February 4, 2011
Last verified: February 2011
  Purpose

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.

Condition Intervention Phase
Infection
Drug: Levofloxacin (HR355) and Rifampicin Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A National, Multicenter, Non-comparative Study Evaluating the Efficacy of the Combination of Levofloxacin (500 mg) and Rifampicin (600 or 900 mg Depending on Weight) Administered Once Daily by Oral Route, as Replacement of Empirical Antibiotic Therapy Given Intravenously With a Total Duration of 6 Weeks of the Antibiotic Therapy, in the Treatment of OsteoArticular Prosthetic Infections (OAPI), With a Two-stage Revision of the Prosthesis.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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. [ Time Frame: During the reimplantation of the new prosthesis i.e. 15 days to 3 months after the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical failure [ Time Frame: 12 months after reimplantation of the prosthesis ] [ Designated as safety issue: No ]
  • Joint mobility function score [ Time Frame: 12 months after reimplantation of the prosthesis ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Levofloxacin and Rifampicin
Drug: Levofloxacin (HR355) and Rifampicin Therapy

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


  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
  • Patient over 65 years of age and who has received corticosteroids.
  • Breast-feeding female.
  • Pregnant female or female who is likely to become pregnant.
  • HIV infection.
  • Inflammatory rheumatism.
  • Treatment with immunosuppressive agents, cardiovascular, neurological or endocrine disease, or other medically significant disease (cancer, etc.) making the conduct of the protocol or the interpretation of the results of the trial difficult.
  • A history of abuse of medicinal products or of alcohol.
  • A patient who may receive treatments that are not authorized by the protocol during the trial.
  • Treatment with another product undergoing pharmaceutical development during the 4 weeks prior to inclusion in the trial.
  • Patient participating in another trial.
  • Patient who is allergic to gentamicin, in the event of implantation of a spacer or of cement with gentamicin.
  • Mental condition making the patient incapable of understanding the nature, objectives and possible consequences of the trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906048

Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Nathalie Billon sanofi-aventis administrative office
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00906048     History of Changes
Other Study ID Numbers: LEVOF_L_03815, 2008-003284-39(EudraCT)
Study First Received: May 20, 2009
Last Updated: February 4, 2011
Health Authority: France: Institutional Ethical Committee

Additional relevant MeSH terms:
Communicable Diseases
Infection
Levofloxacin
Ofloxacin
Rifampin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antibiotics, Antitubercular
Antineoplastic Agents
Antitubercular Agents
Enzyme Inhibitors
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Renal Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014