Health TrialsbyHealthPanel

Pharmacokinetics of Antibiotics in Patients Undergoing Renal Replacement Therapies

ConditionRenal Replacement Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCleveland Clinic Abu Dhabi

About this trial

The study is aiming to describe the pharmacokinetic and pharmacodynamic profile of intravenous meropenem, ertapenem, cefepime, colistin, Ceftazidime/Avibactam , Ceftolozane/Tazobactam , and piperacillin/tazobactam in the plasma and determine how much is removed by Renal Replacement Therapies to ensure adequate dosing

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults > 18 year old

Prescribed meropenem, ertapenem, cefepime, colistin, Ceftazidime/Avibactam , Ceftolozane/Tazobactam , or piperacillin/tazobactam for treatment of infection as part of standard medical care

Administered meropenem, ertapenem, cefepime, colistin, Ceftazidime/Avibactam , Ceftolozane/Tazobactam ,or piperacillin/tazobactam while on renal replacement therapy (IHD or CRRT) or renal replacement therapy started while on any of these antibiotics

Patients with hemoglobin > 70 g/L without blood transfusion in the past 24 hours

Disqualifiers

Less than 18 years of age

Pregnant females

Body mass index < 18 or > 35 kg/m2

Presence of anemia (defined as hemoglobin < 70 g/L), thrombocytopenia, or leukopenia as defined by hematocrit, platelet, or white blood cell count < 75% of the lower limit of normal

Trial population

Patients on renal replacement therapy, prescribed antibiotics in the regular course of care

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Blood collection

    Other intervention

    Pharmacokinetics

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Serum antibiotic concentrations over time during dose interval

Blood will be collected at designated time points, serum samples will be assayed for drug concentration over time to describe pharmacokinetic disposition

Time frame
24 months

Secondary outcomes

1

Amount of antibiotic removed by dialysis

Dialysate will be collected and assayed for drug concentration to determine the amount of drug cleared by RRT with respect to different dialysis modalities and membranes

Time frame
24 months
2

Time above minimum inhibitory concentration (T/MIC) for time dependent antibiotics

Concentration/time data will be modeled mathematically (population pharmacokinetics and Monte Carlo simulation) to identify adequate dosing in this patient population

Time frame
24 months
3

Area under concentration time curve over minimum inhibitory concentration for (Cmax/MIC) for concentration dependent antibiotics

Concentration/time data will be modeled mathematically (population pharmacokinetics and Monte Carlo simulation) to identify adequate dosing in this patient population

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cleveland Clinic Abu Dhabi

Lead sponsor

University of the Sciences in Philadelphia

Collaborator

Source ClinicalTrials.gov
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