- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01019395
Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics
An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged 3 Months to Twenty-Four Months Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Bacterial Infection Including Peri-Operative Prophylactic Use of Antibiotics
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Arkansas
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Little Rock, Arkansas, États-Unis, 72202
- Arkansas Children's Hospital
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California
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Orange, California, États-Unis, 92868
- Children's Hospital of Orange County
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San Diego, California, États-Unis, 92123
- Rady Children's Hospital-San Diego
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Louisiana
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Shreveport, Louisiana, États-Unis, 71103
- University of Louisiana at Monroe
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Missouri
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Kansas City, Missouri, États-Unis, 64108
- Children's Mercy Hospital and Clinics
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Ohio
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Cleveland, Ohio, États-Unis, 44106
- University Hospitals Case Medical Center
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Toledo, Ohio, États-Unis, 43606
- Toledo Children's Hospital
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Texas
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Fort Worth, Texas, États-Unis, 76104
- Cook Children's Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
1. Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care; 2.1 Male or female between the ages of 3 months and 24 months, inclusive; 3. Able to comply with the protocol for the duration of the study; 4.1 Clinically stable with no evidence of hemodynamic instability (defined as a requirement for inotropic or vasodilatory support to manage blood pressure) in the 24 hour window prior to first dose, and no history or evidence of renal or hepatic compromise; 5.1 Suspected or diagnosed bacterial infection for which the subject is receiving standard antibiotic therapy; including prophylactic use of antibiotics peri-operatively; 6. A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline; 7. Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline; 8.1 Presence of two patent intravenous lines (or comparable means of venous or arterial access)prior to dosing on Study Day 1. A single intravenous line (or comparable means of venous access) is acceptable for both drug administration and sample collection if reasonable effort to gain a second line is unsuccessful. The line must be flushed as described in Appendix B of the protocol prior to obtaining PK samples. PK sample can be obtained from a peri-operatively placed arterial line. Arterial PK samples should be indicated on the CRF.
Exclusion Criteria:
- Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
- Known allergy/ hypersensitivity to daptomycin; 3.1 History of clinically significant, renal, hepatic, autoimmune disease or primary immune deficiency;
4. Deleted 5. Subjects with clinically significant abnormal laboratory test results (including ECGs), as determined by Investigator; 6. Administration of rifampin within 7 days of study drug administration; 7. Deleted 8. Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator); 9. Deleted; 10.1 Planned administration of intramuscular injection within 12 hours following study administration unless approved by the Medical Monitor; 11. Deleted 12.1 Guillian-Barre or spinal cord injury; 13. History of or current rhabdomyolysis.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Group 1
Group 1: Ages 13 months to 24 months inclusive.
Six subjects dosed at 6 mg/kg as a 30 minute infusion.
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Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion; Group 2:Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion; Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.
Autres noms:
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Expérimental: Group 2
Group 2: Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion
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Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion; Group 2:Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion; Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.
Autres noms:
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Expérimental: Group 3
Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.
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Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion; Group 2:Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion; Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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PK of single dose daptomycin in subjects between 3 and 24 months who are receiving standard antibiotic therapy for a Gram-positive infection, including subjects that are receiving prophylactic antibiotics peri-operatively.
Délai: Two years
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Two years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Safety of a single dose daptomycin in subjects between 3 and 24 months, who are receiving standard antibiotic therapy for a Gram-positive infection, including subjects that are receiving prophylactic antibiotics peri-operatively.
Délai: Two years
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Two years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Paula Bokesch, MD, Cubist Pharmaceuticals LLC
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 3009-018
- DAP-PEDS-09-01 (Autre identifiant: Cubist Study Number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Gram Positive Bacterial Infection
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PfizerComplétéInfection à Gram positifÉtats-Unis
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Merck Sharp & Dohme LLCComplétéInfections à Gram positifÉtats-Unis, Bulgarie, Colombie, Norvège, Royaume-Uni
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Cubist Pharmaceuticals LLCComplétéInfection à Gram positif | Concurrent Antibiotic TreatmentÉtats-Unis
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Marin L. Schweizer, PhDUniversity of Pennsylvania; Washington University School of Medicine; University... et autres collaborateursActif, ne recrute pasInfection à Staphylococcus aureusÉtats-Unis
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Assistance Publique - Hôpitaux de ParisInstitut PasteurComplétéInfection à ClostridiumFrance
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Heinrich-Heine University, DuesseldorfGerman Research FoundationComplétéInfection à Staphylococcus aureusFrance, Allemagne, Pays-Bas, Espagne, Royaume-Uni
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King Saud UniversityInconnue
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Oxford University Clinical Research Unit, VietnamNational Hospital for Tropical Diseases, Hanoi, VietnamComplété
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Merck Sharp & Dohme LLCComplétéInfections bactériennes à Gram positif
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PfizerComplétéInfections bactériennes à Gram positif