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

ID: NCT00679835
Status: Completed
Phase: Phase 1
Start Date: June 03, 2008
First Submitted: May 15, 2008
Last Updated: January 07, 2018
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: United States
Conditions: Gram Positive Infection, Concurrent Antibiotic Treatment
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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).

Detailed Description

Condition or disease Intervention/treatment Phase

Concurrent Antibiotic Treatment

Gram Positive Infection

Drug: daptomycin
Other Names
Cubicin
Phase 1

Tracking Information

First Submitted DateMay 15, 2008
Last Update Posted DateJanuary 07, 2018
Actual Start DateJune 03, 2008
Actual Completion DateNovember 20, 2008
Actual Primary Completion DateNovember 20, 2008
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Pharmocokinetics of daptomycin [Time Frame: From pre-dose to 24 hours post-dose]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Safety of daptomycin [Time Frame: Up to 9 days after dosing]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitlePK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
Official TitleAn 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
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).

Detailed Description

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
24
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None
Primary Purpose
Basic Science
Conditions
Concurrent Antibiotic Treatment
Gram Positive Infection
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: daptomycin

i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.

Other Names
Cubicin
Study Groups/Cohorts
Group 1
8 mg/kg over a one hour infusion

Group 2
10mg/kg over a one or two hour infusion

Study Arms
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.

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.

Arm Intervention/Treatment
Experimental Group 1
8 mg/kg over a one hour infusion
Drug : daptomycin
Experimental Group 2
10mg/kg over a one or two hour infusion
Drug : daptomycin

Recruitment Information

Recruitment Status:Completed
Enrollment24
Completion DateNovember 20, 2008
Eligibility 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.
GenderAll
Age2 Years to 6 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00679835
Other Study ID Numbers
3009-023
DAP-PEDS-07-02
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Not Available