Renal Replacement TherapyRRTdoseNCT03636464
Pharmacokinetics of Antibiotics in Patients Undergoing Renal Replacement Therapies
An observational study of Renal Replacement Therapy, run by Cleveland Clinic Abu Dhabi at 1 site in United Arab Emirates.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapy
- What is being tested?
- Blood collection
- How many people
- 200 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Apr 2018to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on renal replacement therapy, prescribed antibiotics in the regular course of care
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Cleveland Clinic Abu Dhabi
Abu Dhabi
Wasim S El Nekidy, PharmD, +97125092000 ext. 47969, elnekiw@ccaduae.ae
Wasim El Nekidy, PharmD
About this study
Official title: Pharmacokinetics and Deposition of Commonly Prescribed Antibiotics in Hospitalized Critically Ill Patients Undergoing Renal Replacement Therapies
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
Read the detailed description
This pharmacokinetic evaluation and clinical outcomes will be an open-label study of 12-16 adult patients/antibiotic dose/modality to a total number of 180-240 patients, admitted to the acute care levels or intensive care unit at Cleveland Clinic Abu Dhabi receiving RRT and prescribed these seven antibiotics as recommended by their treating physicians. The collection of blood, ultrafiltrate or effluent fluids depending on RRT modality (HD or CRRT), and urine samples will begin after participants are administered first dose to determine if a loading dose will be required then after at least three doses (as prescribed by the treating physician) once these drugs will be at steady-state concentration. The study intervention duration will depend on dialysis modality expected to be 3 to 5 days depending on RRT modality and patients will be followed for outcomes (death or cure). Collected blood, effluent and urine samples will be assayed for drug concentration. The concentration data will be modeled by a computer program to determine the pharmacokinetic parameters used to predict future dosing in the case of RRT. Linear/logistic regression will be used as a component of statistical analysis to model the relationship between CRRT machine settings and the amount of the study drugs that will be removed by the filter. Information related to adverse events , clinical and microbiological cure will be collected in case report forms.
- Conditions
- Renal Replacement Therapy
- Being tested
- Blood collection
- Keywords
- Pharmacokinetics, antibiotics, RRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Pharmacokinetics
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (3)
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Apr 2018
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Replacement TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Abu Dhabi
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Sciences in Philadelphia
- Responsible party
- Principal investigator, Wasim El Nekidy, Cleveland Clinic Abu Dhabi
- Investigators
- Wasim El Nekidy, PharmD, Principal investigator, Cleveland Clinic Abu DhabiIslam Ghazi, PharmD, Principal investigator, University of the Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636464
- Sponsor's protocol ID
- A-2017-010
- Acronym
- RRTdose
- Status last verified
- Feb 2023
- First submitted
- 29 Jul 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Deposition of Commonly Prescribed Antibiotics in Hospitalized Critically Ill Patients Undergoing Renal Replacement Therapies
- ClinicalTrials.gov ID
- NCT03636464
- Acronym / sponsor ID
- RRTdose / A-2017-010
- Conditions
- Renal Replacement Therapy
- Keywords
- Pharmacokinetics, antibiotics, RRT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cleveland Clinic Abu DhabiUniversity, hospital or other
- Collaborators
- University of the Sciences in Philadelphia
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This pharmacokinetic evaluation and clinical outcomes will be an open-label study of 12-16 adult patients/antibiotic dose/modality to a total number of 180-240 patients, admitted to the acute care levels or intensive care unit at Cleveland Clinic Abu Dhabi receiving RRT and prescribed these seven antibiotics as recommended by their treating physicians. The collection of blood, ultrafiltrate or effluent fluids depending on RRT modality (HD or CRRT), and urine samples will begin after participants are administered first dose to determine if a loading dose will be required then after at least three doses (as prescribed by the treating physician) once these drugs will be at steady-state concentration. The study intervention duration will depend on dialysis modality expected to be 3 to 5 days depending on RRT modality and patients will be followed for outcomes (death or cure). Collected blood, effluent and urine samples will be assayed for drug concentration. The concentration data will be modeled by a computer program to determine the pharmacokinetic parameters used to predict future dosing in the case of RRT. Linear/logistic regression will be used as a component of statistical analysis to model the relationship between CRRT machine settings and the amount of the study drugs that will be removed by the filter. Information related to adverse events , clinical and microbiological cure will be collected in case report forms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on renal replacement therapy, prescribed antibiotics in the regular course of care
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionPharmacokinetics | Other | – |
Primary outcome
Serum antibiotic concentrations over time during dose interval
Time frame: 24 months
Blood will be collected at designated time points, serum samples will be assayed for drug concentration over time to describe pharmacokinetic disposition
3 secondary outcomes
Amount of antibiotic removed by dialysis
Time frame: 24 months
Time above minimum inhibitory concentration (T/MIC) for time dependent antibiotics
Time frame: 24 months
Area under concentration time curve over minimum inhibitory concentration for (Cmax/MIC) for concentration dependent antibiotics
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wasim El Nekidy, PharmD principal investigator
Cleveland Clinic Abu Dhabi
Islam Ghazi, PharmD principal investigator
University of the Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Replacement Therapy, run by Cleveland Clinic Abu Dhabi at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wasim El Nekidy, PharmD (+971 2 6590200 ext. 47969, ElnekiW@ClevelandClinicAbuDhabi.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum antibiotic concentrations over time during dose interval (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.