Staphylococcal InfectionsDALARINCT02782078
Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
A study testing Clindamycin and rifampicin dosages in people with Staphylococcal Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA guidelines) but some interaction is observed. The objective of this study is to evaluate and quantify rifampicin interaction on clindamycin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- Clindamycin and rifampicin dosages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2017to 3 Jan 2019
- 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
- patients ≥18 years of age
- osteoarticular infection
- staphylococcus detected in bacteriological sampling
- sensibility to rifampicin, erythromycin and clindamycin
- active intravenous antibiotherapy against staphylococcus detected in bacteriological sampling
Who cannot join
- septic shock or severe initial sepsis
- osteoarticular infection with other microorganism than staphylococcus
- contraindication to clindamycin or rifampicin including case of hypersensibility to one of these two antibiotics
- pre-existing renal insufficiency or severe renal insufficiency (creatinine clearance <30 ml/min)
- serious cognitive disorders
- patient under guardianship, trusteeship or non affiliated to social security or CMU (beneficiary or assignee)
Show all 12Show fewer
- refusal to take part in the study and to sign the consent form
- pregnancy
- lactation
- administration of clindamycin or rifampicin within the month before inclusion
- treatment with enzymatic inductor or inhibitor within the month before inclusion
- participation to another study modifying antibiotic treatment administration
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Interne - Hôpital Bichat Claude Bernard
Paris, 75018
About this study
Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA guidelines) but some interaction is observed. The objective of this study is to evaluate and quantify rifampicin interaction on clindamycin
Read the detailed description
It could suggest modification of recommended doses or incitement to antibiotic dosage. Thus, theses antibiotics, if association is allowed, could limit fluoroquinolones prescription and avoid some antibiotic resistance.
- Conditions
- Staphylococcal Infections
- Being tested
- Clindamycin and rifampicin dosages
- Keywords
- osteoarticular infection, rifampicin, clindamycin, enzymatic induction, antibiotherapy resistance
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin and rifampicin dosagesBiological
blood samples for clindamycin and rifampicin dosages (for each patient)
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin and rifampicin dosages | Other | blood samples for clindamycin and rifampicin dosages (for each patient) Receives: Biological: Clindamycin and rifampicin dosages |
What is being measured
The primary outcome is the main question the study is designed to answer.
clindamycin AUC (area under curve) at steady state and after rifampicin introduction
this AUC of clindamycin will be compared to AUC before rifampicin introduction, at day 0
Measured: clindamycin AUC will be evaluated after rifampicin interaction, so at day 14 of introduction
Secondary outcomes (4)
rifampicin auto induction
rifampicin autoinduction will be studied with rifampicin AUC, according time, for each patient, at day 4 and day 14. Comparison of AUC with student's test
Measured: AUC of rifampicin at day 4 (before autoinduction ant at steady state) and day 14 (after autoinduction)
clinical outcome
resolution of symptoms first described (pain, swelling, fever…) with specific scale
Measured: at day 4, day 14, day 28 (or day 60 if osteosynthesis)
biological outcome
resolution of inflammatory syndrome (measure of C reactive protein) and hyperleucocytosis (WBC)
Measured: at day 4, day 14, day 28 (or day 60 if osteosynthesis)
side effects and toxicity: number of participants with treatment related adverse events as assessed by CTCAE v4.0
skin lesion, digestive symptoms, clostridium infection, liver cytolysis, hematological disorders (leucopenia, hemolytic anemia, thrombopenia)…
Measured: at day 2, day 4, day 14, day 28 (or day 60 if osteosynthesis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start6 Mar 2017
- Primary completion12 Dec 2018
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine Goulenok, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782078
- Sponsor's protocol ID
- P140318 / AOR14027
- Acronym
- DALARI
- Status last verified
- Mar 2020
- First submitted
- 2 May 2016
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
- ClinicalTrials.gov ID
- NCT02782078
- Acronym / sponsor ID
- DALARI / P140318 / AOR14027
- Conditions
- Staphylococcal Infections
- Keywords
- osteoarticular infection, rifampicin, clindamycin, enzymatic induction, antibiotherapy resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 25 May 2016 (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.
Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA guidelines) but some interaction is observed. The objective of this study is to evaluate and quantify rifampicin interaction on clindamycin
Detailed description
It could suggest modification of recommended doses or incitement to antibiotic dosage. Thus, theses antibiotics, if association is allowed, could limit fluoroquinolones prescription and avoid some antibiotic resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clindamycin and rifampicin dosages | Other | Biological: Clindamycin and rifampicin dosagesblood samples for clindamycin and rifampicin dosages (for each patient) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients ≥18 years of age
- osteoarticular infection
- staphylococcus detected in bacteriological sampling
- sensibility to rifampicin, erythromycin and clindamycin
- active intravenous antibiotherapy against staphylococcus detected in bacteriological sampling
Key exclusion criteria (12 listed)
- septic shock or severe initial sepsis
- osteoarticular infection with other microorganism than staphylococcus
- contraindication to clindamycin or rifampicin including case of hypersensibility to one of these two antibiotics
- pre-existing renal insufficiency or severe renal insufficiency (creatinine clearance <30 ml/min)
- serious cognitive disorders
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 |
|---|---|---|
| Clindamycin and rifampicin dosagesblood samples for clindamycin and rifampicin dosages (for each patient) | Biological | Clindamycin and rifampicin dosages |
Primary outcome
clindamycin AUC (area under curve) at steady state and after rifampicin introduction
Time frame: clindamycin AUC will be evaluated after rifampicin interaction, so at day 14 of introduction
this AUC of clindamycin will be compared to AUC before rifampicin introduction, at day 0
4 secondary outcomes
rifampicin auto induction
Time frame: AUC of rifampicin at day 4 (before autoinduction ant at steady state) and day 14 (after autoinduction)
clinical outcome
Time frame: at day 4, day 14, day 28 (or day 60 if osteosynthesis)
biological outcome
Time frame: at day 4, day 14, day 28 (or day 60 if osteosynthesis)
side effects and toxicity: number of participants with treatment related adverse events as assessed by CTCAE v4.0
Time frame: at day 2, day 4, day 14, day 28 (or day 60 if osteosynthesis)
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 27 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Tiphaine Goulenok, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clindamycin and rifampicin dosages in people with Staphylococcal Infections, 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 5 inclusion and 12 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 27 Mar 2020. 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?
clindamycin AUC (area under curve) at steady state and after rifampicin introduction (time frame: clindamycin AUC will be evaluated after rifampicin interaction, so at day 14 of introduction). 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 27 Mar 2020.