Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation (DARTAGNAN)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Association Pour La Promotion A Tours De La Reanimation Medicale.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Association Pour La Promotion A Tours De La Reanimation Medicale
Information provided by:
Association Pour La Promotion A Tours De La Reanimation Medicale
ClinicalTrials.gov Identifier:
NCT00861315
First received: March 12, 2009
Last updated: March 13, 2009
Last verified: March 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.
| Condition | Intervention | Phase |
|---|---|---|
|
Ventilator Associated Pneumonia |
Drug: Nebulized amikacin Drug: Intravenous amikacin Drug: Placebo nebulization Drug: Placebo infusion |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase II Study of High Dose Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation |
Resource links provided by NLM:
MedlinePlus related topics:
Pneumonia
Drug Information available for:
Amikacin sulfate
U.S. FDA Resources
Further study details as provided by Association Pour La Promotion A Tours De La Reanimation Medicale:
Primary Outcome Measures:
- Determintion of nebulized amikacin dose (60 mg/Kg, 80 mg/Kg or 100 mg/Kg) which results in serum amikacin concentrations equal or below the serum amikacin concentrations measured after 20 mg/Kg intravenous amikacin infusion [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Comparison of clinical pulmonary infection score evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Comparison of serum procalcitonin concentration evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Comparison of c reactive protein evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Comparison duration of mechanical ventilation between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nebulized amikacin
Patients receive nebulized amikacin once a day during three days. Placebo is administered intravenousely
|
Drug: Nebulized amikacin
Amikacin is nebulized at a dose of 60 mg/Kg (6 first patients of the arm), 80 mg/Kg (6 subsequent patients) or 100 mg/Kg (last 6 patients of the arm)
Drug: Placebo infusion
0.9% saline is administered intravenousely once a day during three days
|
| Active Comparator: Intravenous amikacin |
Drug: Intravenous amikacin
20 mg/Kg amikacin are administred intravenousely once a day during three days.
Drug: Placebo nebulization
0.9% saline solution is nebulized once a day during three days
|
Detailed Description:
After inclusion, patients undergo intravenous infusion of 20 mg/Kg of amikacin with amikacin serum concentrations being monitored over the following 24 hours.
Randomization occures after this first amikacin infusion. Patients are randomized to group nebulized amikacin or intravenous amikacin. The three next days of the study patients recieve nebulized amikacin (or nebulized placebo) during mechanical ventilation and a placebo infusion (amikacin infusion in case of placebo nebulization) using a air driven jet nebulizer. Amikacin serum concentrations are monitored over 24 hours after each nebulization.
Patients are followed up during 10 days for safety and efficacy. The dose of amikacin to be nebulized is 60 mg/Kg for the first 6 patients (phase A), 80 mg/Kg for the next 6 patients (phase B) and 100 mg/Kg for the last 6 patients (phase C). Each phase is started after review of the results of the preceeding phase by an idependent safety and monitoring board.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients admitted to intensive care unit.
- Patients undergoing mechanical ventilation for more than 48H.
- Suspicion of ventilator associated pneumonia.
Exclusion Criteria:
- Allergy to amikacin or any compound of the medication.
- Body mass index > 30 kg/m2.
- Myasthenia gravis.
- Acute or chronic renal failure.
- Vestibulo-cochlear disease.
- Pregnancy.
- Brain death.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861315
Contacts
| Contact: Stephan Ehrmann, MD | +33(0)671103302 | stephanehrmann@gmail.com |
Locations
| France | |
| Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU | Recruiting |
| Tours, Indre et Loire, France, F37044 | |
| Contact: Stephan Ehrmann, MD +33(0)671103302 stephanehrmann@gmail.com | |
| Principal Investigator: Stephan Ehrmann, MD | |
| Sub-Investigator: Emmanuelle Mercier, MD | |
| Sub-Investigator: Pierre-François Dequin, MD, PhD | |
| Sub-Investigator: Denis Garot, MD | |
| Sub-Investigator: Annick Legras, MD | |
| Sub-Investigator: Dominique Perrotin, MD | |
| Service de réanimation médicale. Hôpital La Source. CH Orléans | Recruiting |
| Orléans, Loiret, France, F45067 | |
| Contact: Thierry Boulain, MD +33(0)238514446 thierry.boulain@chr-orleans.fr | |
| Principal Investigator: Thierry Boulain, MD | |
Sponsors and Collaborators
Association Pour La Promotion A Tours De La Reanimation Medicale
More Information
No publications provided
| Responsible Party: | Pr Dominique Perrotin, Association Pour La Promotion A Tours De La Reanimation Medicale |
| ClinicalTrials.gov Identifier: | NCT00861315 History of Changes |
| Other Study ID Numbers: | DARTAGNAN |
| Study First Received: | March 12, 2009 |
| Last Updated: | March 13, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Association Pour La Promotion A Tours De La Reanimation Medicale:
|
Pneumonia Nebulization Amikacin |
Additional relevant MeSH terms:
|
Pneumonia Pneumonia, Ventilator-Associated Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection |
Ventilator-Induced Lung Injury Lung Injury Amikacin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013