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

NCT00679835 | Completed Phase 1

• 2 other identifiers: 3009-023DAP-PEDS-07-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Gram Positive Infection; Concurrent Antibiotic Treatment

Outcome Measures

Primary Outcomes (1)

• Pharmocokinetics of daptomycin

  From pre-dose to 24 hours post-dose

Secondary Outcomes (1)

• Safety of daptomycin

  Up to 9 days after dosing

Study Arms (2)

Group 1

EXPERIMENTAL

8 mg/kg over a one hour infusion

Drug: daptomycin

Group 2

EXPERIMENTAL

10mg/kg over a one or two hour infusion

Drug: daptomycin

Interventions

daptomycin DRUG

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

Also known as: Cubicin

Group 1; Group 2

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• Abdel-Rahman SM, Chandorkar G, Akins RL, Bradley JS, Jacobs RF, Donovan J, Benziger DP. Single-dose pharmacokinetics and tolerability of daptomycin 8 to 10 mg/kg in children aged 2 to 6 years with suspected or proved Gram-positive infections. Pediatr Infect Dis J. 2011 Aug;30(8):712-4. doi: 10.1097/INF.0b013e31820fc8e1.

  PMID: 21317681 RESULT

MeSH Terms

Interventions

Daptomycin

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: June 3, 2008
• Primary Completion: November 20, 2008
• Study Completion: November 20, 2008
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)