Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT00136292
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT00136292
Study Brief:
Protocol Section:
NCT00136292