Evaluating how antibiotics behave in patients on kidney dialysis
Pharmacokinetics and Deposition of Commonly Prescribed Antibiotics in Hospitalized Critically Ill Patients Undergoing Renal Replacement Therapies
This study is testing how different antibiotics work in adults on kidney dialysis to find the right doses for effective treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cleveland Clinic Abu Dhabi Academic / other |
| Locations | 1 site (Abu Dhabi) |
| Trial ID | NCT03636464 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the pharmacokinetics and pharmacodynamics of several antibiotics in patients undergoing renal replacement therapy (RRT). It will involve 180-240 adult patients receiving intravenous antibiotics while on RRT, with blood and fluid samples collected to analyze drug concentrations. The study will help determine the appropriate dosing of these antibiotics to ensure effective treatment. Data will be modeled to predict future dosing requirements based on the RRT modality used.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are prescribed specific antibiotics while receiving renal replacement therapy.
Not a fit: Patients under 18, pregnant women, or those with certain health conditions like severe anemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to optimized antibiotic dosing for patients undergoing renal replacement therapy, improving treatment outcomes.
How similar studies have performed: While pharmacokinetic studies in similar contexts exist, this specific evaluation of multiple antibiotics in RRT patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Abu Dhabi
- Cleveland Clinic Abu Dhabi — Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Wasim El Nekidy, PharmD — Cleveland Clinic Abu Dhabi
- Study coordinator: Wasim El Nekidy, PharmD
- Email: ElnekiW@ClevelandClinicAbuDhabi.ae
- Phone: +971 2 6590200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.