InfectionPhase 3NCT00906048
LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection
A Phase 3 study testing Levofloxacin (HR355) and Rifampicin Therapy in people with Infection, run by Sanofi at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Levofloxacin (HR355) and Rifampicin Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Levofloxacin (HR355) and Rifampicin Therapy
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin (HR355) and Rifampicin TherapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Levofloxacin and Rifampicin Receives: Drug: Levofloxacin (HR355) and Rifampicin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the reimplantation of the new prosthesis i.e. 15 days to 3 months after the end of treatment
Secondary outcomes (2)
Clinical failure
Measured: 12 months after reimplantation of the prosthesis
Joint mobility function score
Measured: 12 months after reimplantation of the prosthesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nathalie Billon, Study director, sanofi-aventis administrative office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906048
- Sponsor's protocol ID
- LEVOF_L_03815
- Other IDs
- 2008-003284-39(EudraCT), 2008
- Status last verified
- Feb 2011
- First submitted
- 20 May 2009
- Last updated
- 7 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00906048
- Acronym / sponsor ID
- LEVOF_L_03815
- Conditions
- Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levofloxacin (HR355) and Rifampicin TherapyLevofloxacin and Rifampicin |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacin (HR355) and Rifampicin TherapyFilm-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 | Drug | 1 |
Primary outcome
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
2 secondary outcomes
Clinical failure
Time frame: 12 months after reimplantation of the prosthesis
Joint mobility function score
Time frame: 12 months after reimplantation of the prosthesis
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2011.
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Billon study director
sanofi-aventis administrative office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin (HR355) and Rifampicin Therapy in people with Infection, run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2011.