Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

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ClinicalTrials.gov Identifier: NCT01745679

Recruitment Status : Completed

First Posted : December 10, 2012

Last Update Posted : October 5, 2016

Sponsor:

Information provided by (Responsible Party):

Nantes University Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Meningitis Neurological Infections	Drug: Ceftriaxone treatment	Phase 4

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	198 participants
Intervention Model:	Single Group Assignment
Masking:	None (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.
Study Start Date :	December 2012
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Drug Information available for: Ceftriaxone Ceftriaxone sodium

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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 ]

Secondary Outcome Measures :

Neurological troubles [ Time Frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks ]
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 ]
Time of return to apyrexia, health complications and lenght of hospital stay will be registered.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745679

Locations

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France
Nantes Universitary Hospital
Nantes, Loire Atlantique, France, 44093
Angers Universitary Hospital
Angers, France, 49933
La Roche/Yon hospital
La Roche/Yon, France, 85925
Poitiers Universitary hospital
Poitiers, France, 86021
Rennes Universitary hospital
Rennes, France, 35033
St Nazaire hospital
St Nazaire, France, 44600
Tours universitary hospital
Tours, France, 37170

Sponsors and Collaborators

Nantes University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Grégoire 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, Sébille 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). pii: e00634-19. doi: 10.1128/AAC.00634-19. Print 2019 Sep.

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Responsible Party:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT01745679
Other Study ID Numbers:	RC12_0171
First Posted:	December 10, 2012 Key Record Dates
Last Update Posted:	October 5, 2016
Last Verified:	October 2016

Keywords provided by Nantes University Hospital:


Ceftriaxone Adverse drug effects Therapeutic monitoring Meningitis

Additional relevant MeSH terms:

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Infection Meningitis Central Nervous System Diseases Nervous System Diseases	Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents

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