Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2015 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01745679
First received: December 4, 2012
Last updated: November 20, 2015
Last verified: November 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis Neurological Infections |
Drug: Ceftriaxone treatment |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections. |
Resource links provided by NLM:
Further study details as provided by Nantes University Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Neurological troubles [ Time Frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks ] [ Designated as safety issue: Yes ]Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome.
- clinical evolution [ Time Frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks ] [ Designated as safety issue: No ]Time of return to apyrexia, health complications and lenght of hospital stay will be registered.
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ceftriaxone treatment
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
|
Drug: Ceftriaxone treatment
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient under guardianship
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745679
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745679
Contacts
| Contact: Nathalie ASSERAY, PH | +33 2 40 08 33 16 | nasseray@chu-nantes.fr | |
| Contact: dominique NAVAS, PH | +33 2 40 08 41 54 | dominique.navas@chu-nantes.fr |
Locations
| France | |
| Nantes Universitary Hospital | Recruiting |
| Nantes, Loire Atlantique, France, 44093 | |
| Contact: Nathalie ASSERAY, PH +33 2 40 08 33 16 nasseray@chu-nantes.fr | |
| Principal Investigator: Nathalie ASSERAY, PH | |
| Angers Universitary Hospital | Recruiting |
| Angers, France, 49933 | |
| Contact: Pierre PiAbgueguen, PH PiAbgueguen@chu-angers.fr | |
| Principal Investigator: Pierre ABGUEGUEN, PH | |
| La Roche/Yon hospital | Recruiting |
| La Roche/Yon, France, 85925 | |
| Contact: Thomas GUIMARD, PH thomas.guimard@chd-vendee.fr | |
| Principal Investigator: Thomas GUIMARD, PH | |
| Poitiers Universitary hospital | Recruiting |
| Poitiers, France, 86021 | |
| Contact: France ROBLOT, PU-PH f.roblot@chu-poitiers.fr | |
| Principal Investigator: France ROBLOT, PU-PH | |
| Rennes Universitary hospital | Recruiting |
| Rennes, France, 35033 | |
| Contact: Pierre TATTEVIN, PH +33 2 99 28 43 21 pierre.tattevin@chu-rennes.fr | |
| Principal Investigator: Pierre TATTEVIN, PH | |
| St Nazaire hospital | Recruiting |
| St Nazaire, France, 44600 | |
| Contact: Jérôme HOFF, PH j.hoff@ch-saintnazaire.fr | |
| Principal Investigator: Jérôme HOFF, PH | |
| Tours universitary hospital | Recruiting |
| Tours, France, 37170 | |
| Contact: Louis BERNARD, PU-PH garot@med.univ-tours.fr | |
| Principal Investigator: Louis BERNARD, PU-PH | |
Sponsors and Collaborators
Nantes University Hospital
More Information
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01745679 History of Changes |
| Other Study ID Numbers: | RC12-0171 |
| Study First Received: | December 4, 2012 |
| Last Updated: | November 20, 2015 |
| Health Authority: | France:ANSM |
Keywords provided by Nantes University Hospital:
|
Ceftriaxone Adverse drug effects Therapeutic monitoring Meningitis |
Additional relevant MeSH terms:
|
Infection Meningitis Central Nervous System Diseases Nervous System Diseases |
Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 27, 2016