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 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT01019395
Eligibility Criteria:
Inclusion Criteria:
1\. Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care; 2.1 Male or female between the ages of 3 months and 24 months, inclusive; 3. Able to comply with the protocol for the duration of the study; 4.1 Clinically stable with no evidence of hemodynamic instability (defined as a requirement for inotropic or vasodilatory support to manage blood pressure) in the 24 hour window prior to first dose, and no history or evidence of renal or hepatic compromise; 5.1 Suspected or diagnosed bacterial infection for which the subject is receiving standard antibiotic therapy; including prophylactic use of antibiotics peri-operatively; 6. A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline; 7. Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline; 8.1 Presence of two patent intravenous lines (or comparable means of venous or arterial access)prior to dosing on Study Day 1. A single intravenous line (or comparable means of venous access) is acceptable for both drug administration and sample collection if reasonable effort to gain a second line is unsuccessful. The line must be flushed as described in Appendix B of the protocol prior to obtaining PK samples. PK sample can be obtained from a peri-operatively placed arterial line. Arterial PK samples should be indicated on the CRF.
Exclusion Criteria:
1. Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
2. Known allergy/ hypersensitivity to daptomycin; 3.1 History of clinically significant, renal, hepatic, autoimmune disease or primary immune deficiency;
4\. Deleted 5. Subjects with clinically significant abnormal laboratory test results (including ECGs), as determined by Investigator; 6. Administration of rifampin within 7 days of study drug administration; 7. Deleted 8. Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator); 9. Deleted; 10.1 Planned administration of intramuscular injection within 12 hours following study administration unless approved by the Medical Monitor; 11. Deleted 12.1 Guillian-Barre or spinal cord injury; 13. History of or current rhabdomyolysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
24 Months
Study:
NCT01019395
Study Brief:
Protocol Section:
NCT01019395