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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
NCT01745679 |
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Date of registration:
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04/12/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
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Scientific title:
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Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections. |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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198 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01745679 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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Phase 4
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neurological Infections
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Meningitis
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Intervention(s)
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Drug: Ceftriaxone treatment
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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clinical evolution
[Time Frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks]
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Neurological troubles
[Time Frame: participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks]
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Secondary ID(s)
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RC12_0171
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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