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Kansas City, Missouri 64108


Purpose:

This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria).


Criteria:

Inclusion Criteria: - Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care; - Male or female between the ages of 2 and 6 years old, inclusive; - Able to comply with the protocol for the duration of the study; - Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise; - Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy; - A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline; - Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline. - Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1. 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; - History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency; - Pneumonia as sole Gram-positive infection being treated with standard antibiotics; - Subjects with clinically significant abnormal laboratory test results [including electrocardiograms (ECGs)], as determined by Investigator; - Administration of rifampin within 7 days of study drug administration; - Body mass index (BMI) that is outside of the 5th to 95th percentile; - Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator); - History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder; - Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing; - Expected surgical procedure(s) within 24 hours prior to and following dosing; - Unexplained muscular weakness, history of peripheral neuropathy, Guillian-Barre or spinal cord injury; - History of or current rhabdomyolysis.


NCT ID:

NCT00679835


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Kansas City, Missouri 64108
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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