## Protocol Section
### Identification Module
**NCT ID:** NCT01745679

**Brief Title:** Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

**Official Title:** Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.

#### Organization Study ID Info
**ID:** RC12_0171
#### Organization
**Class:** OTHER
**Full Name:** Nantes University Hospital
### Status Module
#### Completion Date
**Date:** 2015-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-10-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-10-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-12

**Type:** ACTUAL

#### Start Date
**Date:** 2012-12

**Status Verified Date:** 2016-10

#### Study First Post Date
**Date:** 2012-12-10
**Type:** ESTIMATED
**Study First Submit Date:** 2012-12-04
**Study First Submit QC Date:** 2012-12-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nantes University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- Meningitis

- Neurological Infections

**Keywords:**

- Ceftriaxone

- Adverse drug effects

- Therapeutic monitoring

- Meningitis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 198

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** ceftriaxone will be administered à high dose : \> or equal to 75mg/kg/day or 4 gr/day

**Intervention Names:**

- Drug: Ceftriaxone treatment

**Label:** Ceftriaxone treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ceftriaxone treatment

**Description:** ceftriaxone will be administered à high dose : \> or equal to 75mg/kg/day or 4 gr/day

**Name:** Ceftriaxone treatment

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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

#### Secondary Outcomes

**Description:** Neurological troubles explored by electroencephalogram aiming to diagnose epileptic syndrome.

**Measure:** Neurological troubles

**Time Frame:** participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks

**Description:** Time of return to apyrexia, health complications and lenght of hospital stay will be registered.

**Measure:** clinical evolution

**Time Frame:** participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nantes

**Country:** France

**Facility:** Nantes Universitary Hospital

**State:** Loire Atlantique

**Zip:** 44093

**Location 2:**

**City:** Angers

**Country:** France

**Facility:** Angers Universitary Hospital

**Zip:** 49933

**Location 3:**

**City:** La Roche/Yon

**Country:** France

**Facility:** La Roche/Yon hospital

**Zip:** 85925

**Location 4:**

**City:** Poitiers

**Country:** France

**Facility:** Poitiers Universitary hospital

**Zip:** 86021

**Location 5:**

**City:** Rennes

**Country:** France

**Facility:** Rennes Universitary hospital

**Zip:** 35033

**Location 6:**

**City:** St Nazaire

**Country:** France

**Facility:** St Nazaire hospital

**Zip:** 44600

**Location 7:**

**City:** Tours

**Country:** France

**Facility:** Tours universitary hospital

**Zip:** 37170

### References Module

#### References

**Citation:** 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.

**PMID:** 31235630

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000090862

- Term: Neuroinflammatory Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M30303

- Name: Drug-Related Side Effects and Adverse Reactions

- Relevance: LOW

- As Found: Unknown

- ID: M11564

- Name: Meningitis

- Relevance: HIGH

- As Found: Meningitis

- ID: M2803

- Name: Neuroinflammatory Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000008581

- Term: Meningitis

### Intervention Browse Module - Ancestors

- ID: D000097911

- Term: Third Generation Cephalosporins

- ID: D000097902

- Term: Beta Lactam Antibiotics

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5693

- Name: Ceftriaxone

- Relevance: HIGH

- As Found: Antimicrobial

- ID: M5760

- Name: Cephalosporins

- Relevance: LOW

- As Found: Unknown

- ID: M3453

- Name: Third Generation Cephalosporins

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10789

- Name: Lactams

- Relevance: LOW

- As Found: Unknown

- ID: M25772

- Name: beta-Lactams

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M3444

- Name: Beta Lactam Antibiotics

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002443

- Term: Ceftriaxone

### Misc Info Module

- Version Holder: 2024-05-24
