Optimal dosing of antibiotics in (morbidly) obesee patients
Recruiting
- Conditions
- (Morbid) Obesity, Pharmacokinetics, Antibiotics, Infective diseases
- Registration Number
- NL-OMON29597
- Lead Sponsor
- St. Antonius Hospital, Nieuwegein
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 102
Inclusion Criteria
Inclusion criteria for (morbidly) obese participants:
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Renal insufficiency identified by eGFR < 60 ml/min/1.73m2;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is clearance (Cl) of gentamicin, tobramycin, vancomycin or ciprofloxacin in obese participants versus normal weight participants. Other primary endpoints are volume of distribution (Vd) and 24-hour renal clearance for all four drugs and oral bioavailability (F) for ciprofloxacin in obese participants versus normal weight participants.
- Secondary Outcome Measures
Name Time Method Influence of covariates (total bodyweight, lean bodyweight, fat mass, gender, length, age, creatinine, metabolomic profile, GFR) on primary parameters of interest (i.e. clearance and volume of distribution).