Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics

Sponsor

Cubist Pharmaceuticals LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00136292

Collaborator

(none)

Enrollment

Locations

11.5

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin in patients aged 2-17 years old who have a suspected or proven gram-positive infection for which they are receiving standard antibiotic therapy. The tolerability of a single dose of daptomycin in these patients will also be assessed.

Condition or Disease	Intervention/Treatment	Phase
Gram-positive Bacterial Infections	Drug: daptomycin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

An Evaluation of the Pharmacokinetics of a Single Dose of Daptomycin (4 mg/kg) in Pediatric Patients Aged Two to Seventeen Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection

Actual Study Start Date :

Aug 24, 2005

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 9, 2006

Outcome Measures

Primary Outcome Measures

Pharmacokinetic []

Secondary Outcome Measures

Tolerability []

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

2-17 years old
Suspected or diagnosed gram-positive infection for which the patient is receiving standard antibiotic therapy
Clinically stable with no evidence of hemodynamic instability in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise, or clinically significant alterations in fluid/electrolyte homeostasis
Creatinine clearance (CLcr) ≥ 80 ml/min/1.73 m2 as determined by the Schwartz equation
Creatine phosphokinase (CPK) levels within normal limits

Exclusion Criteria:

Known allergy to daptomycin
History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, or autoimmune disease
Pneumonia as sole gram-positive infection
Use of HMG-CoA reductase inhibitors or other systemic anti-hyperlipidemic agents within 7 days prior to study drug administration and expected use through 3 days post-dose
Clinically significant abnormal laboratory test results (including electrocardiograms [ECGs]), as determined by Investigator
Body mass index (BMI) that is outside of the 5th to 95th percentile for age
History (personal or 1st degree relative) of clinically significant muscular disease, nervous system, seizure or psychiatric disorder
Expected intramuscular (IM) injection within 3 days following dosing
Expected surgical procedure(s) within 3 days following dosing
Unexplained muscular weakness
Rhabdomyolysis, myositis or septic shock

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72202
2	Children's Mercy Hospitals and Clinics	Kansas City	Missouri	United States	64108
3	University of Texas Southwestern	Dallas	Texas	United States	75390