Osteoarticular InfectionCLINDOSNCT01500837
Treatment of Methicillin-sensitive Staphylococcus Aureus (MSSA)
A study testing association of RIFAMPIN + CLINDAMYCIN and association of LEVOFLOXACIN+ CLINDAMYCIN in people with Osteoarticular Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Background: 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarticular Infection
- What is being tested?
- association of RIFAMPIN + CLINDAMYCIN and association of LEVOFLOXACIN+ CLINDAMYCIN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Oct 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject over 18 years with a IOA with GERME sensitivity to three antibiotics,
- Patient in orthopedic unit of HEGP,
- Patient who received and understood the information and who signed consent,
Who cannot join
- Known allergy to one of three antibiotics and / or excipients,
- Pregnancy or during lactation,
- Congenital galactosemia, malabsorption of glucose and galactose, or lactase deficiency,
- History of tendinopathy with fluoroquinolones,
- G6PD deficiency,
- porphyria,
Show all 10Show fewer
- subject receiving a protease inhibitor,
- subject receiving anticoagulants
- Malabsorption syndrome,
- subject unable to follow the protocol (organizational problem, intellectual disability, ...).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Methicillin-sensitive Staphylococcus Aureus Orthopaedic Infections With Clindamycin in Combination With Rifampin or Levofloxacin: a Randomized Pharmacological and Clinical Study (the CLINDOS Trial)
Background:
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.
Read more
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.
Read the detailed description
Background:
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
- Osteoarticular Infection
- Being tested
- association of RIFAMPIN + CLINDAMYCIN, association of LEVOFLOXACIN+ CLINDAMYCIN
- Keywords
- Staphylococcus aureus, osteoarticular infection, clindamycin, serum concentration, orthopedic surgery
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
association of RIFAMPIN + CLINDAMYCINDrug
Also called RIFAMPIN
association of RIFAMPIN + CLINDAMYCIN
association of LEVOFLOXACIN+ CLINDAMYCINDrug
Also called LEVOFLOXACIN
association of LEVOFLOXACIN+ CLINDAMYCIN
| Study group | Role | What they receive |
|---|---|---|
| RIFAMPIN | Active comparator | CLINDAMYCIN + RIFAMPIN Receives: Drug: association of RIFAMPIN + CLINDAMYCIN |
| LEVOFLOXACIN | Active comparator | CLINDAMYCIN + LEVOFLOXACIN Receives: Drug: association of LEVOFLOXACIN+ CLINDAMYCIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of peak and trough serum concentrations of clindamycin
Measurement of peak and trough serum concentrations of clindamycin will be performed at Day 1, Day 15 and Day 30
Measured: 1 month
Secondary outcomes (1)
proportion of patients healing (as determined from absence of fever, absence of pain and favorable aspect of scar).
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarticular InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Sabatier, PD, PhD, Study director, Department of Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500837
- Sponsor's protocol ID
- K000000
- Acronym
- CLINDOS
- Status last verified
- Sep 2010
- First submitted
- 28 Nov 2011
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25936632
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Methicillin-sensitive Staphylococcus Aureus Orthopaedic Infections With Clindamycin in Combination With Rifampin or Levofloxacin: a Randomized Pharmacological and Clinical Study (the CLINDOS Trial)
- ClinicalTrials.gov ID
- NCT01500837
- Acronym / sponsor ID
- CLINDOS / K000000
- Conditions
- Osteoarticular Infection
- Keywords
- Staphylococcus aureus, osteoarticular infection, clindamycin, serum concentration, orthopedic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Dec 2011 (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.
Background:
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
Background:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIFAMPIN | Active comparator | Drug: association of RIFAMPIN + CLINDAMYCINCLINDAMYCIN + RIFAMPIN |
| LEVOFLOXACIN | Active comparator | Drug: association of LEVOFLOXACIN+ CLINDAMYCINCLINDAMYCIN + LEVOFLOXACIN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subject over 18 years with a IOA with GERME sensitivity to three antibiotics,
- Patient in orthopedic unit of HEGP,
- Patient who received and understood the information and who signed consent,
Key exclusion criteria (10 listed)
- Known allergy to one of three antibiotics and / or excipients,
- Pregnancy or during lactation,
- Congenital galactosemia, malabsorption of glucose and galactose, or lactase deficiency,
- History of tendinopathy with fluoroquinolones,
- G6PD deficiency,
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 |
|---|---|---|
| association of RIFAMPIN + CLINDAMYCINAlso: RIFAMPINassociation of RIFAMPIN + CLINDAMYCIN | Drug | RIFAMPIN |
| association of LEVOFLOXACIN+ CLINDAMYCINAlso: LEVOFLOXACINassociation of LEVOFLOXACIN+ CLINDAMYCIN | Drug | LEVOFLOXACIN |
Primary outcome
Measurement of peak and trough serum concentrations of clindamycin
Time frame: 1 month
Measurement of peak and trough serum concentrations of clindamycin will be performed at Day 1, Day 15 and Day 30
1 secondary outcome
proportion of patients healing (as determined from absence of fever, absence of pain and favorable aspect of scar).
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
- Derived from this study: PubMed 25936632Bernard 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.
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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.
Brigitte Sabatier, PD, PhD study director
Department of Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing association of RIFAMPIN + CLINDAMYCIN and association of LEVOFLOXACIN+ CLINDAMYCIN in people with Osteoarticular Infection, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 18 Sep 2013. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of peak and trough serum concentrations of clindamycin (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01500837, which also lists 1 linked publication.
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 18 Sep 2013.