Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01745679 |
Recruitment Status :
Completed
First Posted : December 10, 2012
Last Update Posted : October 5, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meningitis Neurological Infections | Drug: Ceftriaxone treatment | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 198 participants |
Allocation: | N/A |
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 |
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 |
- 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 ]
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |
Ceftriaxone Adverse drug effects Therapeutic monitoring Meningitis |
Infections Meningitis Central Nervous System Diseases Nervous System Diseases |
Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents |