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

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ClinicalTrials.gov Identifier: NCT00679835
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Gram Positive Infection Concurrent Antibiotic Treatment Drug: daptomycin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : June 3, 2008
Primary Completion Date : November 20, 2008
Study Completion Date : November 20, 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Pharmocokinetics of daptomycin [ Time Frame: From pre-dose to 24 hours post-dose ]

Secondary Outcome Measures :
  1. Safety of daptomycin [ Time Frame: Up to 9 days after dosing ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679835

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

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00679835     History of Changes
Other Study ID Numbers: 3009-023
DAP-PEDS-07-02 ( Other Identifier: Cubist Study Number )
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:



URL: http://

Additional relevant MeSH terms:
Communicable Diseases
Anti-Bacterial Agents
Anti-Infective Agents