Pharmacokinetic and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections

• Conditions: Gram-positive Infection; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002781-23-Outside-EU/EEA
• Lead Sponsor: Cubist Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-29
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Male or female subjects between the ages of 2 and 6 years old, inclusive, with suspected or diagnosed Gram-positive infection for which the subject was receiving standard antibiotic therapy were specific candidates for the study. Subjects were required to be 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, with calculated creatinine clearance rate (CLcr) ?80 mL/min/1.73 m2 as determined by the Schwartz equation, CPK levels <2X upper limit of normal (ULN), and presence of 2 patent i.v. lines (or comparable means of venous access) prior to dosing on Study Day 1.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
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
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects were to be excluded from the study if they met any of the following criteria:
1.Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
2.Known allergy/hypersensitivity to daptomycin
3.History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma was acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;
4.Pneumonia as sole Gram-positive infection being treated with standard antibiotics;
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.Body mass index (BMI) that was outside of the 5th to 95th percentile;
8.Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);
9.History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;
10.Administration of intramuscular (IM) injection between baseline and study drug administration or expected IM injection within 24 hours following dosing;
11.Expected surgical procedure(s) within 24 hours prior to and following dosing;
12.Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
13.History of or current rhabdomyolysis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified