Pharmacokinetics of Antibiotics in Patients Undergoing Renal Replacement Therapies

Launched by CLEVELAND CLINIC ABU DHABI · Aug 16, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how certain antibiotics behave in the body of patients undergoing treatments for kidney failure, known as renal replacement therapies. The researchers want to understand how well these antibiotics, including meropenem, cefepime, and others, are processed in the bloodstream and how much of the medication is removed during these treatments. This information is important to make sure that patients receive the right amount of antibiotics to fight infections effectively.

To participate in this study, you must be an adult over 18 years old who has been prescribed one of the antibiotics listed for an infection while receiving renal replacement therapy. You should also have a certain level of hemoglobin, a protein in your blood, to ensure your safety during the study. If you join, you can expect to have blood samples taken to measure how the antibiotics are working in your body. The trial is currently recruiting participants and aims to improve antibiotic treatment for patients with kidney issues.

Gender

ALL

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