Pharmacokinetics of Antibiotics in Patients Undergoing Renal Replacement Therapies

NCT03636464 | Recruiting DMC

• 1 other identifier: A-2017-010
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Replacement Therapy

Keywords

Pharmacokinetics; antibiotics; RRT

Outcome Measures

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

  24 months

Secondary Outcomes (3)

• Amount of antibiotic removed by dialysis

  24 months

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

  24 months

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

  24 months

Interventions

Blood collection OTHER

Pharmacokinetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Informed consent given by patient, next of kin or legally authorized representative

You may not qualify if:

• 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
• Concomitant receipt of another cephalosporin interfering with assay
• Participants likely to require surgical interventions during the study period if the surgery would interfere with dosing intervals or affect sampling process
• Protected patients; prisoners, patients with HIV, patients with physical or mental disabilities, psychiatric patients.
• Patients with documented life-threatening allergy (i.e anaphylaxis, angioedema) to any of the study drugs or their class.
• Patients with conditions known to significantly affect PK; (i.e. severe burn, significant ascites, spinal cord injury and cystic fibrosis)
• Any other reason felt by the investigators to potentially affect the outcomes of the study

Sponsors & Collaborators

• Cleveland Clinic Abu Dhabi: lead
• University of the Sciences in Philadelphia: collaborator

Study Sites (1)

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Wasim El Nekidy, PharmD

  Cleveland Clinic Abu Dhabi

  PRINCIPAL INVESTIGATOR

• Islam Ghazi, PharmD

  University of the Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wasim El Nekidy, PharmD

CONTACT

+971 2 6590200; ElnekiW@ClevelandClinicAbuDhabi.ae

Islam Ghazi, PharmD

CONTACT

+12152688908; i.ghazi@usciences.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Pharmacotherapy Specialist

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 17, 2018
• Study Start: April 1, 2018
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

AE (1)