MeningitisPhase 4NCT01745679
Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
A Phase 4 study testing Ceftriaxone treatment in people with Meningitis and Neurological Infections, run by Nantes University Hospital at 7 sites in France.
Trial summary
The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. Additionally, we aimed to detect adverse effect, especially neurological trouble related to Ceftriaxone toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis, Neurological Infections
- What is being tested?
- Ceftriaxone treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 7 sitesFrance
- Study dates
- Dec 2012to Dec 2015
- 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
- Hospitalized adults patients,
- age equal or above 18
- Patients with Community or surgical acquired neurological infections, meningitis and others
- Prescription of ceftriaxone >75mg/kg/d or >4g/d -
- Subjects affiliated to French health insurance (social security)
- Informed consent form signed
Who cannot join
- Patient under guardianship
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Angers Universitary Hospital
Angers, 49933
La Roche/Yon hospital
La Roche/Yon, 85925
Nantes Universitary Hospital
Nantes, Loire Atlantique, 44093
Poitiers Universitary hospital
Poitiers, 86021
Rennes Universitary hospital
Rennes, 35033
St Nazaire hospital
Saint-Nazaire, 44600
Tours universitary hospital
Tours, France, 37170
About this study
Official title: Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.
The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. Additionally, we aimed to detect adverse effect, especially neurological trouble related to Ceftriaxone toxicity.
Read the detailed description
Day 0 : onset of treatment by Ceftriaxone, following usual therapeutic process (French Guideline) From Day 0 to Day 4 : inclusion, clinical and biological data collection, electroencephalogram at baseline.
Two samples for ceftriaxone concentration monitoring :
- Trough concentration of ceftriaxone at steady state
- A random sample (population PK) At the end of ceftriaxone treatment : assessment of tolerance and efficacy of the treatment.
- Conditions
- Meningitis, Neurological Infections
- Being tested
- Ceftriaxone treatment
- Keywords
- Ceftriaxone, Adverse drug effects, Therapeutic monitoring, Meningitis
- Medical subject headings
- Meningitis, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone treatmentDrug
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
| Study group | Role | What they receive |
|---|---|---|
| Ceftriaxone treatment | Experimental | ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day Receives: Drug: Ceftriaxone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least).
Measured: after at least 48 hours of ceftriaxone treatment
Secondary outcomes (2)
Neurological troubles
Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome.
Measured: participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks
clinical evolution
Time of return to apyrexia, health complications and lenght of hospital stay will be registered.
Measured: participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionDec 2015
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 Nantes 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745679
- Sponsor's protocol ID
- RC12_0171
- Status last verified
- Oct 2016
- First submitted
- 4 Dec 2012
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gregoire M, Dailly E, Le Turnier P, Garot D, Guimard T, Bernard L, Tattevin P, Vandamme YM, Hoff J, Lemaitre F, Verdier MC, Deslandes G, Bellouard R, Sebille V, Chiffoleau A, Boutoille D, Navas D, Asseray N. High-Dose Ceftriaxone for Bacterial Meningitis and Optimization of Administration Scheme Based on Nomogram. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00634-19. doi: 10.1128/AAC.00634-19. Print 2019 Sep.
PubMed 31235630
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.
- ClinicalTrials.gov ID
- NCT01745679
- Acronym / sponsor ID
- RC12_0171
- Conditions
- Meningitis, Neurological Infections
- Keywords
- Ceftriaxone, Adverse drug effects, Therapeutic monitoring, Meningitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Dec 2012 (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.
The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. Additionally, we aimed to detect adverse effect, especially neurological trouble related to Ceftriaxone toxicity.
Detailed description
Day 0 : onset of treatment by Ceftriaxone, following usual therapeutic process (French Guideline) From Day 0 to Day 4 : inclusion, clinical and biological data collection, electroencephalogram at baseline.
Two samples for ceftriaxone concentration monitoring :
- Trough concentration of ceftriaxone at steady state
- A random sample (population PK) At the end of ceftriaxone treatment : assessment of tolerance and efficacy of the treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone treatment | Experimental | Drug: Ceftriaxone treatmentceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized adults patients,
- age equal or above 18
- Patients with Community or surgical acquired neurological infections, meningitis and others
- Prescription of ceftriaxone >75mg/kg/d or >4g/d -
- Subjects affiliated to French health insurance (social security)
Key exclusion criteria (1 listed)
- Patient under guardianship
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 |
|---|---|---|
| Ceftriaxone treatmentceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day | Drug | Ceftriaxone treatment |
Primary outcome
plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least).
Time frame: after at least 48 hours of ceftriaxone treatment
2 secondary outcomes
Neurological troubles
Time frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks
clinical evolution
Time frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks
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 5 Oct 2016.
- Derived from this study: PubMed 31235630Gregoire M, Dailly E, Le Turnier P, Garot D, Guimard T, Bernard L, Tattevin P, Vandamme YM, Hoff J, Lemaitre F, Verdier MC, Deslandes G, Bellouard R, Sebille V, Chiffoleau A, Boutoille D, Navas D, Asseray N. High-Dose Ceftriaxone for Bacterial Meningitis and Optimization of Administration Scheme Based on Nomogram. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00634-19. doi: 10.1128/AAC.00634-19. Print 2019 Sep.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftriaxone treatment in people with Meningitis and Neurological Infections, run by Nantes University Hospital at 7 sites 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 6 inclusion and 1 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 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least). (time frame: after at least 48 hours of ceftriaxone treatment). 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 NCT01745679, 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 5 Oct 2016.