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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT00679835
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
6 Years
Study:
NCT00679835
Study Brief:
Protocol Section:
NCT00679835