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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014