InfectionPhase 4FLUO-POPNCT02357407
Development of an Adjustment Assistance Tool Dosage of Fluoroquinolones in a Population Pharmacokinetic Model
A Phase 4 study testing Patients in intensive care : infection treated with ciprofloxacin IV and Osteoarticular infected patients : infection treated with oral ofloxacin in people with Infection, run by Rennes University Hospital at 1 site in France.
Trial summary
Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat infections. Their efficacy has been shown to be linked to the ratio area under the curve (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the bacteria treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Patients in intensive care : infection treated with ciprofloxacin IV and Osteoarticular infected patients : infection treated with oral ofloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 2016
- Phase
- Phase 4
- 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
- Age over 18 years
- Patients in intensive care : Infection treated with ciprofloxacin IV
- Osteoarticular infected patients : infection treated with oral ofloxacin
- Written consent to participate in the study
Who cannot join
- Pregnancy
- Adults subject to legal protection or deprived of their liberty
Trial locations and contacts
1 site in 1 country.
About this study
Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat infections. Their efficacy has been shown to be linked to the ratio area under the curve (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the bacteria treated. Eventually, Forrest et al., reported in gram-negative infections that an AUC/MIC above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30 to 40% in patients with an AUC/MIC below this threshold. These results have been reproduced recently by Zelenitsky et al. in intensive care unit (ICU) patients with threshold similar to the one obtained by Forrest et al. Lastly, elevated concentrations of FQ should be related with the onset of adverse events. Thus, therapeutic drug monitoring (TDM) of FQ appears of potential interest, particularly in case of severe infections (intensive care unit (ICU) patients) or complicated and cost-related infections (osteoarticular infected (OAI) patients), with an increasing level of evidence of its use.
However, FQ TDM requires access to the full AUC of the drug with the need of many samples drawn to patients. This appears to be irreconcilable with clinical practice but can be achieved using population pharmacokinetic (PkPop) modelling. PkPop allows estimating pharmacokinetic parameters of the drug by introducing covariates (demographic, biological, clinical…) and modelling inter-individual pharmacokinetic variability. The model created allows then accessing to individual parameters of patients and thus, estimating concentrations and AUC of the FQ. This approach may also be used in clinical practice to determine a limited sampling strategy allowing an adequate estimation of AUC with a minimum of samples.
Read the detailed description
Open, prospective, monocentric pharmacokinetic study
- Conditions
- Infection
- Being tested
- Patients in intensive care : infection treated with ciprofloxacin IV, Osteoarticular infected patients : infection treated with oral ofloxacin
- Keywords
- fluoroquinolones, pharmacokinetic, infections
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients in intensive care : infection treated with ciprofloxacin IVDrug
Also called Blood samples
8-10 samples per patients on day-4 of their treatment
Osteoarticular infected patients : infection treated with oral ofloxacinDrug
Also called Blood samples
8-10 samples per patients on day-4 of their treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients in intensive care | Experimental | 30 patients in intensive care treated with ciprofloxacin IV Receives: Drug: Patients in intensive care : infection treated with ciprofloxacin IV |
| Osteoarticular infected patients | Experimental | 30 patients in orthopedics treated with oral ofloxacin Receives: Drug: Osteoarticular infected patients : infection treated with oral ofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration measurement of ciprofloxacin and ofloxacin
measurement between 2 administrations (8-10 samples per patients)
Measured: on day-4 of their treatment (steady-state)
Secondary outcomes (6)
Demographic data
Measured: on day-4 of their treatment (steady-state)
Biological data
Measured: on day-4 of their treatment (steady-state)
Clinical data
Measured: on day-4 of their treatment (steady-state)
AUC
Measured: on day-4 of their treatment (steady-state)
MIC
Measured: on day-4 of their treatment (steady-state)
Cmax
Measured: on day-4 of their treatment (steady-state)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
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 InfectionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno BL Laviolle, MD/PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357407
- Sponsor's protocol ID
- 2014-004193-4
- Other IDs
- 35RC14_9179, 2014
- Acronym
- FLUO-POP
- Status last verified
- May 2023
- First submitted
- 16 Jan 2015
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Lemaitre F, Fily F, Foulquier JB, Revest M, Jullien V, Petitcollin A, Tattevin P, Tron C, Polard JL, Verdier MC, Comets E, Huten D, Arvieux C, Bellissant E, Laviolle B. Development of a dosing-adjustment tool for fluoroquinolones in osteoarticular infections: The Fluo-pop study. Biomed Pharmacother. 2021 Oct;142:112053. doi: 10.1016/j.biopha.2021.112053. Epub 2021 Aug 19.
PubMed 34435591
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Adjustment Assistance Tool Dosage of Fluoroquinolones in a Population Pharmacokinetic Model
- ClinicalTrials.gov ID
- NCT02357407
- Acronym / sponsor ID
- FLUO-POP / 2014-004193-4
- Conditions
- Infection
- Keywords
- fluoroquinolones, pharmacokinetic, infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Feb 2015 (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.
Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat infections. Their efficacy has been shown to be linked to the ratio area under the curve (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the bacteria treated. Eventually, Forrest et al., reported in gram-negative infections that an AUC/MIC above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30 to 40% in patients with an AUC/MIC below this threshold. These results have been reproduced recently by Zelenitsky et al. in intensive care unit (ICU) patients with threshold similar to the one obtained by Forrest et al. Lastly, elevated concentrations of FQ should be related with the onset of adverse events. Thus, therapeutic drug monitoring (TDM) of FQ appears of potential interest, particularly in case of severe infections (intensive care unit (ICU) patients) or complicated and cost-related infections (osteoarticular infected (OAI) patients), with an increasing level of evidence of its use.
However, FQ TDM requires access to the full AUC of the drug with the need of many samples drawn to patients. This appears to be irreconcilable with clinical practice but can be achieved using population pharmacokinetic (PkPop) modelling. PkPop allows estimating pharmacokinetic parameters of the drug by introducing covariates (demographic, biological, clinical…) and modelling inter-individual pharmacokinetic variability. The model created allows then accessing to individual parameters of patients and thus, estimating concentrations and AUC of the FQ. This approach may also be used in clinical practice to determine a limited sampling strategy allowing an adequate estimation of AUC with a minimum of samples.
Detailed description
Open, prospective, monocentric pharmacokinetic study
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in intensive care | Experimental | Drug: Patients in intensive care : infection treated with ciprofloxacin IV30 patients in intensive care treated with ciprofloxacin IV |
| Osteoarticular infected patients | Experimental | Drug: Osteoarticular infected patients : infection treated with oral ofloxacin30 patients in orthopedics treated with oral ofloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Patients in intensive care : Infection treated with ciprofloxacin IV
- Osteoarticular infected patients : infection treated with oral ofloxacin
- Written consent to participate in the study
Key exclusion criteria (2 listed)
- Pregnancy
- Adults subject to legal protection or deprived of their liberty
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 |
|---|---|---|
| Patients in intensive care : infection treated with ciprofloxacin IVAlso: Blood samples8-10 samples per patients on day-4 of their treatment | Drug | Patients in intensive care |
| Osteoarticular infected patients : infection treated with oral ofloxacinAlso: Blood samples8-10 samples per patients on day-4 of their treatment | Drug | Osteoarticular infected patients |
Primary outcome
Plasma concentration measurement of ciprofloxacin and ofloxacin
Time frame: on day-4 of their treatment (steady-state)
measurement between 2 administrations (8-10 samples per patients)
6 secondary outcomes
Demographic data
Time frame: on day-4 of their treatment (steady-state)
Biological data
Time frame: on day-4 of their treatment (steady-state)
Clinical data
Time frame: on day-4 of their treatment (steady-state)
AUC
Time frame: on day-4 of their treatment (steady-state)
MIC
Time frame: on day-4 of their treatment (steady-state)
Cmax
Time frame: on day-4 of their treatment (steady-state)
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 24 May 2023.
- Results publication: PubMed 34435591Lemaitre F, Fily F, Foulquier JB, Revest M, Jullien V, Petitcollin A, Tattevin P, Tron C, Polard JL, Verdier MC, Comets E, Huten D, Arvieux C, Bellissant E, Laviolle B. Development of a dosing-adjustment tool for fluoroquinolones in osteoarticular infections: The Fluo-pop study. Biomed Pharmacother. 2021 Oct;142:112053. doi: 10.1016/j.biopha.2021.112053. Epub 2021 Aug 19.
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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.
Bruno BL Laviolle, MD/PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patients in intensive care : infection treated with ciprofloxacin IV and Osteoarticular infected patients : infection treated with oral ofloxacin in people with Infection, run by Rennes University Hospital 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 4 inclusion and 2 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 24 May 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Plasma concentration measurement of ciprofloxacin and ofloxacin (time frame: on day-4 of their treatment (steady-state)). 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 NCT02357407, 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 24 May 2023.