Clinical trial NCT00136292: Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gram-positive Bacterial Infections
Keywords: Gram-Positive Infection
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 33
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


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

Primary outcomes:
measure: Pharmacokinetic
Secondary outcomes:
measure: Tolerability
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: University of Arkansas
name: Richard Jacobs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.