EUCTR2015-002218-60-Outside-EU/EEA
Active, not recruiting
Not Applicable
An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 1 to 17 Years
ConditionsGram-Positive Bacterial InfectionsMedDRA version: 18.0Level: LLTClassification code 10053021Term: Gram-positive bacterial infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsVibativ
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gram-Positive Bacterial Infections
- Sponsor
- Theravance Biopharma Antibiotics, Inc.
- Enrollment
- 32
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is 1 to 17 years (inclusive) and has a height/length/weight (for subjects between 12 and 23 months) or body mass index (BMI, for subjects 2 to 17 years) within the 5th to 95th percentile (inclusive) for age and sex.
- •Subject requires intravenous antibiotics for:
- •Gram\-positive bacterial infection OR
- •prophylaxis of Gram\-positive infection OR
- •empiric therapy for suspected Gram\-positive infection
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 32
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •Subject has an estimated creatinine clearance \<50 mL/min/1\.73 m2 (Schwartz formula).
- •Subject requires concomitant vancomycin treatment.
- •Subject requires concomitant administration of agents containing cyclodextrin
- •Subject has a history of allergies or hypersensitivities to glycopeptide antibiotics (e.g., vancomycin), telavancin, or the formulation excipients
Outcomes
Primary Outcomes
Not specified
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