Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics

NCT00136292 | Completed Phase 1

• 2 other identifiers: 3009-028DAP-PEDS-05-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin in patients aged 2-17 years old who have a suspected or proven gram-positive infection for which they are receiving standard antibiotic therapy. The tolerability of a single dose of daptomycin in these patients will also be assessed.

Conditions

Gram-positive Bacterial Infections

Keywords

Gram-Positive Infection

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic

Secondary Outcomes (1)

• Tolerability

Interventions

daptomycin DRUG

Eligibility Criteria

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

You may qualify if:

• years old
• Suspected or diagnosed gram-positive infection for which the patient is receiving standard antibiotic therapy
• Clinically stable with no evidence of hemodynamic instability in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise, or clinically significant alterations in fluid/electrolyte homeostasis
• Creatinine clearance (CLcr) ≥ 80 ml/min/1.73 m2 as determined by the Schwartz equation
• Creatine phosphokinase (CPK) levels within normal limits

You may not qualify if:

• Known allergy to daptomycin
• History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, or autoimmune disease
• Pneumonia as sole gram-positive infection
• Use of HMG-CoA reductase inhibitors or other systemic anti-hyperlipidemic agents within 7 days prior to study drug administration and expected use through 3 days post-dose
• Clinically significant abnormal laboratory test results (including electrocardiograms \[ECGs\]), as determined by Investigator
• Body mass index (BMI) that is outside of the 5th to 95th percentile for age
• History (personal or 1st degree relative) of clinically significant muscular disease, nervous system, seizure or psychiatric disorder
• Expected intramuscular (IM) injection within 3 days following dosing
• Expected surgical procedure(s) within 3 days following dosing
• Unexplained muscular weakness
• Rhabdomyolysis, myositis or septic shock

Sponsors & Collaborators

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

Study Sites (3)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Abdel-Rahman SM, Benziger DP, Jacobs RF, Jafri HS, Hong EF, Kearns GL. Single-dose pharmacokinetics of daptomycin in children with suspected or proved gram-positive infections. Pediatr Infect Dis J. 2008 Apr;27(4):330-4. doi: 10.1097/INF.0b013e318160edfc.

  PMID: 18316988 RESULT

MeSH Terms

Conditions

Gram-Positive Bacterial Infections

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

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

Study Officials

• Richard Jacobs, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: August 24, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 9, 2006
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)