Treatment of Methicillin-sensitive Staphylococcus Aureus (MSSA)
NCT ID: NCT01500837
Last Updated: 2013-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2010-10-31
2011-10-31
Brief Summary
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One of the leading causes of peri-operative osteoarticular infections (OAI) is Staphylococcus aureus. Treatment usually requires surgical debridement in association with appropriate antibiotic therapy. After surgery, an intravenous (IV) antibiotic therapy is routinely indicated for 10 to 15 days, followed by a minimal one-month oral treatment. In this protocol, the latter includes clindamycin in combination with rifampin or levofloxacin. Clindamycin is considered a good option in staphylococcal infections, because of its action against biofilm formation and bacterial adherence, its high level of joint and bone penetration and its good tolerance. Rifampin, a potent cytochrome P-450 inducer, enhances the elimination of a large number of drugs. Therefore, an influence of rifampin on clindamycin pharmacokinetics must be considered.
Objectives:
The primary objective is to compare the influence of rifampin and levofloxacin respectively on the pharmacokinetics of clindamycin in a randomized series of peri-operative staphylococcal OAI. The investigators then seek to determine the optimal drug association with regard to infection control and drug tolerance.
Study design:
Monocentric, randomized, open label, comparative study
Study period:
From November 2010 to October 2011.
Materials and Methods:
Following surgical debridement and after 10 to 15 days of IV antibiotherapy, patients are randomly assigned either to the "clindamycin/rifampin" arm either to the "clindamycin/levofloxacin" arm, according to the antimicrobial susceptibility testing. Peak and trough serum concentrations of clindamycin are measured at day-1, day-15 and day-30 of oral treatment. Rifampin and levofloxacin serum concentrations are measured at the same intervals to monitor patient compliance.
Detailed Description
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One of the leading causes of peri-operative osteoarticular infections (OAI) is Staphylococcus aureus. Treatment usually requires surgical debridement in association with appropriate antibiotic therapy. After surgery, an intravenous (IV) antibiotic therapy is routinely indicated for 10 to 15 days, followed by a minimal one-month oral treatment. In this protocol, the latter includes clindamycin in combination with rifampin or levofloxacin. Clindamycin is considered a good option in staphylococcal infections, because of its action against biofilm formation and bacterial adherence, its high level of joint and bone penetration and its good tolerance. Rifampin, a potent cytochrome P-450 inducer, enhances the elimination of a large number of drugs. Therefore, an influence of rifampin on clindamycin pharmacokinetics must be considered.
Objectives:
The primary objective is to compare the influence of rifampin and levofloxacin respectively on the pharmacokinetics of clindamycin in a randomized series of peri-operative staphylococcal OAI. The investigators then seek to determine the optimal drug association with regard to infection control and drug tolerance. Study design: monocentric, randomized, open label, comparative study
Study period:
From November 2010 to October 2011.
Materials and Methods:
Following surgical debridement and after 10 to 15 days of IV antibiotherapy, patients are randomly assigned either to the "clindamycin/rifampin" arm either to the "clindamycin/levofloxacin" arm, according to the antimicrobial susceptibility testing. Peak and trough serum concentrations of clindamycin are measured at day-1, day-15 and day-30 of oral treatment. Rifampin and levofloxacin serum concentrations are measured at the same intervals to monitor patient compliance. Infection cure is evaluated clinically, with periodic X-rays and CRP dosage in serum.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RIFAMPIN
CLINDAMYCIN + RIFAMPIN
association of RIFAMPIN + CLINDAMYCIN
association of RIFAMPIN + CLINDAMYCIN
LEVOFLOXACIN
CLINDAMYCIN + LEVOFLOXACIN
association of LEVOFLOXACIN+ CLINDAMYCIN
association of LEVOFLOXACIN+ CLINDAMYCIN
Interventions
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association of RIFAMPIN + CLINDAMYCIN
association of RIFAMPIN + CLINDAMYCIN
association of LEVOFLOXACIN+ CLINDAMYCIN
association of LEVOFLOXACIN+ CLINDAMYCIN
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient in orthopedic unit of HEGP,
* Patient who received and understood the information and who signed consent,
Exclusion Criteria
* Pregnancy or during lactation,
* Congenital galactosemia, malabsorption of glucose and galactose, or lactase deficiency,
* History of tendinopathy with fluoroquinolones,
* G6PD deficiency,
* porphyria,
* subject receiving a protease inhibitor,
* subject receiving anticoagulants
* Malabsorption syndrome,
* subject unable to follow the protocol (organizational problem, intellectual disability, ...).
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Brigitte Sabatier, PD, PhD
Role: STUDY_DIRECTOR
Department of Pharmacology
Locations
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Assistance Publique Hopitaux de Paris
Paris, , France
Countries
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References
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Bernard A, Kermarrec G, Parize P, Caruba T, Bouvet A, Mainardi JL, Sabatier B, Nich C. Dramatic reduction of clindamycin serum concentration in staphylococcal osteoarticular infection patients treated with the oral clindamycin-rifampicin combination. J Infect. 2015 Aug;71(2):200-6. doi: 10.1016/j.jinf.2015.03.013. Epub 2015 Apr 30.
Other Identifiers
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K000000
Identifier Type: -
Identifier Source: org_study_id