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

NCT ID: NCT00136292

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-24
• Study Completion Date: 2006-08-09

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

daptomycin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Jacobs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

University of Texas Southwestern

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18316988 (View on PubMed)

Other Identifiers

DAP-PEDS-05-01

Identifier Type: OTHER

Identifier Source: secondary_id

3009-028

Identifier Type: -

Identifier Source: org_study_id