NCT03636464 Pharmacokinetics of Antibiotics in Patients Undergoing Renal Replacement Therapies
| NCT ID | NCT03636464 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cleveland Clinic Abu Dhabi |
| Condition | Renal Replacement Therapy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2018-04-01 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2018-04-01 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Wasim El Nekidy, PharmD
PRINCIPAL INVESTIGATOR
Cleveland Clinic Abu Dhabi
Frequently Asked Questions
Who can join the NCT03636464 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Replacement Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03636464 currently recruiting?
Yes, NCT03636464 is actively recruiting participants. Contact the research team at ElnekiW@ClevelandClinicAbuDhabi.ae for enrollment information.
Where is the NCT03636464 trial being conducted?
This trial is being conducted at Abu Dhabi, United Arab Emirates.
Who is sponsoring the NCT03636464 clinical trial?
NCT03636464 is sponsored by Cleveland Clinic Abu Dhabi. The principal investigator is Wasim El Nekidy, PharmD at Cleveland Clinic Abu Dhabi. The trial plans to enroll 200 participants.