Clinical trial NCT00679835: PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
Official title: An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six 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 Infection
Concurrent Antibiotic Treatment
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2008-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pharmocokinetics of daptomycin
timeFrame: From pre-dose to 24 hours post-dose
Secondary outcomes:
measure: Safety of daptomycin
timeFrame: Up to 9 days after dosing
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References:
citation: 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.