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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT00882557
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent prior to any study-related procedure not part of normal medical care;
* Male or female ≥ 18 years of age;
* If female of childbearing potential; willing to practice reliable birth control measures during study treatment and for at least 28 days after study completion, not lactating or pregnant, and has a documented negative pregnancy test result within 24 hours prior to study medication administration;
* End-stage renal disease on stable (for at least 2 weeks) hemodialysis regimen, three times weekly using high-flux membranes;
* Functioning hemodialysis access (for example, graft or fistula);
* Considered to be in appropriate health for study entry by the Investigator (for example, no acute, debilitating medical problems) and appropriate candidate for completing study treatment;
* If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study drug administration.
Exclusion Criteria:
* Received an investigational drug (including experimental biologic agents) within 30 days of study drug administration;
* Has received any dose of daptomycin within 7 days prior to study drug administration;
* Known to be allergic or intolerant to daptomycin;
* Evidence of active ongoing infection;
* Known human immunodeficiency virus (HIV) infection with CD4 count ≤ 200 cells/mm3;
* Active illicit drug use or alcohol abuse;
* Myocardial infarction within last 6 months;
* Subject with a history of muscular disease (for example, polymyositis, muscular dystrophy);
* Subject with a history of neurological disease (for example, Guillain Barré, multiple sclerosis), except stroke \> 6 months prior to study entry;
* Intramuscular injection within 7 days of study drug administration;
* Body mass index (BMI) ≤ 18.5 or ≥ 40 kg/m2 (BMI = weight \[kg\]/height \[m2\]);
* WBC ≥ 12, 000 cells/mm3 or ≤ 2500 cells/ mm3;
* Neutropenic subject with absolute neutrophil count ≤ 500 cells/mm3;
* Baseline CPK values ≥ 3X ULN (upper limit of normal);
* Alanine aminotransferase (ALT) \> 5XULN;
* Aspartate aminotransferase (AST) \> 5XULN;
* Hemoglobin ≤ 9 gm/dL;
* Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;
* History of rhabdomyolysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00882557
Study Brief:
Protocol Section:
NCT00882557