Phase 4
Completed N=18
Effect of Weight and/or Obesity on Caspofungin Drug Concentrations
Source: ClinicalTrials.gov NCT01062165 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Total Clearance of Caspofungin — 0.508 L/hr
Summary
This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Clearance of Caspofungin |
0.508 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate.
Exclusion Criteria
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of caspofungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of caspofungin, so that the pregnancy and post-partum state would be a confounding variable.
- Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
- History of allergies to echinocandins.
- Echinocandins are contraindicated for any reason.
- Volunteers unwilling to comply with study procedures.
- Suspected or documented systemic fungal infection.
- Concomitant use of rifamycins, tacrolimus, or cyclosporine
Data sourced from ClinicalTrials.gov (NCT01062165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.