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

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00679835
First received: May 15, 2008
Last updated: September 20, 2010
Last verified: September 2010
  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).


Condition Intervention Phase
Gram Positive Infection
Concurrent Antibiotic Treatment
Drug: daptomycin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Pharmocokinetics of daptomycin [ Time Frame: From pre-dose to 24 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of daptomycin [ Time Frame: Up to 9 days after dosing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
8 mg/kg over a one hour infusion
Drug: daptomycin
i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.
Other Name: Cubicin
Experimental: Group 2
10mg/kg over a one or two hour infusion
Drug: daptomycin
i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.
Other Name: Cubicin

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679835

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ed Campanaro, Cubist Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00679835     History of Changes
Other Study ID Numbers: DAP-PEDS-07-02
Study First Received: May 15, 2008
Last Updated: September 20, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014