NCT03102658

Micafungin Pharmacokinetics in Obese Patients

Micafungin (Mycamine®) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (MICADO).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Because micafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections. Although micafungin is approved for the treatment of invasive candidiasis, dosing guidelines for micafungin in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of micafungin (as well as other echinocandins) in this specific patient population is still largely unknown. To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 100 mg or 200mg micafungin (besides standard anti-bacterial prophylaxis) and samples for a pharmacokinetic curve will be taken. These PK-values can then be compared to the PK in a normal-weight group which will receive 100mg micafungin

Detailed description

Obese patients with a BMI ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery will receive a 100 mg or a 200mg dose of micafungin. A PK curve will be determined after administration at t=0.5, 0.95, 1.25, 1.5, 2, 4, 8, 12, 24, and (if feasible) 48 hours post infusion. Blood samples (4 mL) on PK days will be taken to obtain at least 2.0 mL of plasma.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
DRUG	Micafungin	Administration of study drug

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-04-06
• Last updated: 2020-10-19

Locations

2 sites across 1 country: Netherlands