MeningitisPhase 1CeftarolineNCT02806882
Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF)
A Phase 1 study testing Ceftaroline fosamil in people with Meningitis and Ventriculitis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Ceftaroline is a piece of new cephalosporin very active on resistant staphylococci in methicillin (SEMR: Staphylococcus Epidermidis Resistant in Methicillin, SMAR: Staphylococcus Aureus Resistant in Methicillin)and/or in vancomycin ; Ceftaroline is also very active on pneumococci resistant in penicillin and/or 3rd… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis, Ventriculitis
- What is being tested?
- Ceftaroline fosamil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2015to 24 Oct 2016
- Phase
- Phase 1
- 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
- Adult patients (≥ 18 years)
- Provision of informed consent prior to any study specific procedures
- Female patients of childbearing potential may be entered if pregnancy testing is negative and the patient agrees to abstain from procreational sexual intercourse or must use double-barrier contraceptive measures for the duration of the study
- Presence of an indwelling external cerebrospinal fluid (CSF) access device (ventriculostomy or lumbar drain)
- Presence of inflamed meninges as a result of documented or suspected meningitis or ventriculitis. Patients with both clinical symptoms (fever, headache, meningismus, and altered mentation) and laboratory parameters (CSF leukocytosis, defined as a CSF white blood cell count [WBC] of >10 3, elevated CSF protein, defined as CSF protein of >1g/l, reduced CSF glucose, defined as CSF glucose of <0.3g/l, or a positive CSF Gram stain or culture) indicative of CNS infection were deemed to have definitive bacterial meningitis/ventriculitis. Inflamed meninges were defined as the presence of >5 leukocytes/mm3 of CSF.
Who cannot join
- Patient has documented history of hypersensitivity or allergic reaction (urticaria, angiooedema, anaphylaxis, desquamative rash) to any β-lactam antimicrobial including cephalosporins (contraindication to cephalosporins)
- Patient is pregnant or lactating and intends to continue breastfeeding
- Severe renal insufficiency defined as creatinine clearance < 50 mL/min.
- Patients with conditions known or suspected to alter pharmacokinetics (i.e., burn or cystic fibrosis patients)
- Refusal to participate
- Person not affiliated with the social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftaroline in Patients With CSF Device
Ceftaroline is a piece of new cephalosporin very active on resistant staphylococci in methicillin (SEMR: Staphylococcus Epidermidis Resistant in Methicillin, SMAR: Staphylococcus Aureus Resistant in Methicillin)and/or in vancomycin ; Ceftaroline is also very active on pneumococci resistant in penicillin and/or 3rd generation of cephalosporins.
Ceftaroline was approved by the European Medicines Agency for the treatment of complicated skin and soft tissue infections and community-acquired pneumonia.
Read more
Scientific literature describes a good efficiency in septicemy and/or SAMR endocarditis.
Besides, a study on animal shows the efficiency of ceftaroline in meningeal infections with gram-negative Bacilli.
The rationale of this study is based on the antibacterial spectra of ceftaroline that could be used for the antibacterial treatment (curative and prophylactic) of CSF shunt associated infections.
To validate this hypothesis, it is necessary to evaluate the concentration of ceftaroline in meningeal compartment after treatment.
- Conditions
- Meningitis, Ventriculitis
- Being tested
- Ceftaroline fosamil
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftaroline fosamilDrug
Also called ZINFORO
600mg IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline fosamil | Experimental | 600mg 1 hour intravenous infusion ZINFORO Receives: Drug: Ceftaroline fosamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ceftaroline serum concentration
Measured: before infusion, at 0.5h, 1h, 3h, 6h, 12h, 24h after infusion
Ceftaroline cerebrospinal fluid concentration
Measured: before infusion, at 0.5h, 1h, 3h, 6h, 12h, 24h after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start29 Apr 2015
- Primary completion24 Oct 2016
- Study completion24 Oct 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 MeningitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806882
- Sponsor's protocol ID
- Chavanet AZ 2014
- Acronym
- Ceftaroline
- Status last verified
- Feb 2024
- First submitted
- 14 Jun 2016
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chauzy A, Nadji A, Combes JC, Defrance N, Bouhemad B, Couet W, Chavanet P. Cerebrospinal fluid pharmacokinetics of ceftaroline in neurosurgical patients with an external ventricular drain. J Antimicrob Chemother. 2019 Mar 1;74(3):675-681. doi: 10.1093/jac/dky489.
PubMed 30535190
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftaroline in Patients With CSF Device
- ClinicalTrials.gov ID
- NCT02806882
- Acronym / sponsor ID
- Ceftaroline / Chavanet AZ 2014
- Conditions
- Meningitis, Ventriculitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Apr 2015 (actual)
- Primary completion
- 24 Oct 2016 (actual)
- Study completion
- 24 Oct 2016 (actual)
- First posted
- 21 Jun 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.
Ceftaroline is a piece of new cephalosporin very active on resistant staphylococci in methicillin (SEMR: Staphylococcus Epidermidis Resistant in Methicillin, SMAR: Staphylococcus Aureus Resistant in Methicillin)and/or in vancomycin ; Ceftaroline is also very active on pneumococci resistant in penicillin and/or 3rd generation of cephalosporins.
Ceftaroline was approved by the European Medicines Agency for the treatment of complicated skin and soft tissue infections and community-acquired pneumonia.
Scientific literature describes a good efficiency in septicemy and/or SAMR endocarditis.
Besides, a study on animal shows the efficiency of ceftaroline in meningeal infections with gram-negative Bacilli.
The rationale of this study is based on the antibacterial spectra of ceftaroline that could be used for the antibacterial treatment (curative and prophylactic) of CSF shunt associated infections.
To validate this hypothesis, it is necessary to evaluate the concentration of ceftaroline in meningeal compartment after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftaroline fosamil | Experimental | Drug: Ceftaroline fosamil600mg 1 hour intravenous infusion ZINFORO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥ 18 years)
- Presence of an indwelling external cerebrospinal fluid (CSF) access device (ventriculostomy or lumbar drain)
- Presence of inflamed meninges as a result of documented or suspected meningitis or ventriculitis. Patients with both clinical symptoms (fever, headache, meningismus, and altered mentation) and laboratory parameters (CSF leukocytosis, defined as a CSF white blood cell count [WBC] of >10 3, elevated CSF protein, defined as CSF protein of >1g/l, reduced CSF glucose, defined as CSF glucose of <0.3g/l, or a positive CSF Gram stain or culture) indicative of CNS infection were deemed to have definitive bacterial meningitis/ventriculitis. Inflamed meninges were defined as the presence of >5 leukocytes/mm3 of CSF.
Key exclusion criteria (6 listed)
- Patient has documented history of hypersensitivity or allergic reaction (urticaria, angiooedema, anaphylaxis, desquamative rash) to any β-lactam antimicrobial including cephalosporins (contraindication to cephalosporins)
- Patient is pregnant or lactating and intends to continue breastfeeding
- Severe renal insufficiency defined as creatinine clearance < 50 mL/min.
- Patients with conditions known or suspected to alter pharmacokinetics (i.e., burn or cystic fibrosis patients)
- Refusal to participate
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 |
|---|---|---|
| Ceftaroline fosamilAlso: ZINFORO600mg IV infusion | Drug | Ceftaroline fosamil |
Primary outcome
Ceftaroline serum concentration
Time frame: before infusion, at 0.5h, 1h, 3h, 6h, 12h, 24h after infusion
Ceftaroline cerebrospinal fluid concentration
Time frame: before infusion, at 0.5h, 1h, 3h, 6h, 12h, 24h after infusion
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 21 Feb 2024.
- Derived from this study: PubMed 30535190Chauzy A, Nadji A, Combes JC, Defrance N, Bouhemad B, Couet W, Chavanet P. Cerebrospinal fluid pharmacokinetics of ceftaroline in neurosurgical patients with an external ventricular drain. J Antimicrob Chemother. 2019 Mar 1;74(3):675-681. doi: 10.1093/jac/dky489.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ceftaroline fosamil in people with Meningitis and Ventriculitis, run by Centre Hospitalier Universitaire Dijon 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 6 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 21 Feb 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Ceftaroline serum concentration (time frame: before infusion, at 0.5h, 1h, 3h, 6h, 12h, 24h after infusion). The study lists 2 primary outcomes in all. 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 NCT02806882, 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 21 Feb 2024.