- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01027897
Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients
Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients With Sepsis at Grady Health System
Aperçu de l'étude
Description détaillée
Understanding the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of an antibiotic can provide insight into developing appropriate dosing regimens. It is even more imperative at the present time to maximize PK/PD parameters since there are no new novel antimicrobial agents to treat resistant gram-negative infections. This approach allows us to achieve superior PD parameters and treat bacteria that would have been resistant to standard dosing due to higher minimum inhibitory concentrations (MICs).
Doripenem exhibits time-dependent bactericidal activity and the pharmacodynamic parameter predicting clinical and bacteriologic outcomes is the percentage of the dosing interval that free drug concentrations remain above the minimum inhibitory concentration (T > MIC) of the infecting pathogen Sepsis is known to influence drug pharmacokinetics and pharmacodynamics as a result of changes in hemodynamics, capillary permeability, third spacing, acid-base status, serum proteins, and organ function. Moreover, trauma patients tend to be younger with fewer comorbidities. They are hypermetabolic and are often given aggressive fluid resuscitation resulting in increased renal clearance of drugs and a larger volume of distribution. As a consequence of these differences in PK parameters, the calculated PD parameters will likely differ resulting in sub-optimal T> MIC. For time-dependent antibacterial agents such as doripenem, the T > MIC is one of the most important pharmacodynamic parameters in predicting clinical efficacy, therefore it is imperative to evaluate the PK parameters in this particular population.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Georgia
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Atlanta, Georgia, États-Unis, 30303
- Grady Memorial Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients are 18 years of age or older
- Admitted to Emory surgical intensive care unit (ICU) service
- Have a diagnosis of sepsis that requires empiric antimicrobial therapy
- Obtained written informed consent from the patient or a first-degree relative if the patient is unable to give informed consent due to his/her medical condition prior to initiation of any study procedure
Exclusion Criteria:
- Surgical ICU length of stay less than 24 hours
- Acute or chronic renal dysfunction (urine output less than 0.5 mL/kg/hr or calculated creatinine clearance of less than 50 mL/min)
- Pregnancy
- Known allergy to beta-lactam antibiotics
- Non-English-speaking patients
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Doripenem group
Patients will receive doripenem for the treatment of their infection
|
Doripenem 1 gm administered over 4 hours X 3 doses
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Volume of Distribution (Vd)
Délai: After 3rd dose of study medication
|
The Volume of distribution is the calculated volume that the given amount of drug is uniformly distributed in the body to achieve a particular concentration
|
After 3rd dose of study medication
|
Clearance (CL)
Délai: After 3rd dose of study medication
|
Clearance is the volume of drug removed from the body per unit of time (hrs).
|
After 3rd dose of study medication
|
Elimination Constant (ke)
Délai: after 3rd dose of study drug
|
The elimination rate constant of a drug from the central compartment
|
after 3rd dose of study drug
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jeffrey Salomone, MD, Emory University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00016181a
- DORICPK4003 (Autre identifiant: other)
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