Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

Phase 4

Completed

• Conditions: Fungal Infection; Obesity
• Interventions: Drug: Caspofungin

• Registration Number: NCT01062165
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-12-13
• Results First Submitted QC: 2012-12-13
• Results First Posted: 2013-01-21
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capsofungin	Caspofungin	Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.

Primary Outcome Measures

Name	Time	Method
Total Clearance of Caspofungin	0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States