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

Gram-positive Bacterial Infections Clinical Trial

Official title:

An Evaluation of the Pharmacokinetics of a Single Dose of Daptomycin (4 mg/kg) in Pediatric Patients Aged Two to Seventeen Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136292
• Other study ID #: 3009-028
• Secondary ID: DAP-PEDS-05-01
• Status: Completed
• Phase: Phase 1
• Start date: August 24, 2005
• Est. completion date: August 9, 2006

Study information

• Verified date: March 2020
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 9, 2006
• Est. primary completion date: August 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• 2-17 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Gram-Positive Bacterial Infections
• Infection

Intervention

Drug:
• daptomycin

Locations

Country	Name	City	State
United States	University of Texas Southwestern	Dallas	Texas
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic
Secondary	Tolerability