- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257812
Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: María Luisa Cantón Bulnes
- Phone Number: 955 00 80 00
- Email: luisabulnes@hotmail.com
Study Locations
-
-
-
Sevilla, Spain, 41009
- Hospital Universitario Virgen Macarena
-
Contact:
- María Luisa Cantón Bulnes
- Phone Number: 955 00 80 00
- Email: luisabulnes@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients older than 18 years old.
- Hospitalised for a serious illness.
- Treated with Ceftolozane-Tazobactam
- Patients that signed the Informed Consent.
Exclusion Criteria:
- Allergic to any component of Ceftolozane-Tazobactam.
- Any surgical or medical evidence that according to the investigator could interfere with the pharmacodynamics of the medication: absorption, distribution, metabolism or excretion.
- Concomitant terminal illness.
- Unable to sign the Informed Consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ceftolozane-Tazobactam cohort
Patients older than 18 years old that are hospitalised in the Virgen Macarena University Hospital that are being treated with Ceftolozane-Tazobactam in empiric or targeted treatment.
|
The dose will be 1g ceftolozane + 0,5 g tazobactam every 8 hours or 2 g ceftolozane + 1 g tazobactam, it´s recommended to use this last dose regimen in patients with pneumonia or septic shock of any focus. The patients will be followed as it´s done habitually. There will be done infection focus cultures and others according to usual clinical practice. It´ll be determined the clinical response and mortality in the days 14 and 30 after the beginning of the medicine, respectively. The Ceftolozane-Tazobactam levels determination will always be made in state of equilibrium (after the third dose). Four samples will be collected:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the Ceftolozane-Tazobactam seric concentrations and analyse the clinic impact that could have the dose regimens used until now.
Time Frame: Up to 12 months after the antibiotic administration
|
Determination of the Ceftolozane-Tazobactam seric concentration by collecting 4 blood samples and measuring its antibiotic levels and if it´s achieved an adequate therapeutic efficacy assessed by the patient´s clinical and microbiological recovery. The dose regimens used until now are 1+0,5 g every 8 hours in case of intra-abdominal infection or complicated urinary infection and 2 +1 g every 8 hours in case of pneumonia or septic shock of any focus. |
Up to 12 months after the antibiotic administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with renal hyper clearance.
Time Frame: Up to 12 months after the antibiotic administration
|
Determine if with both dose regimens are achieve the pharmacodynamic and pharmacokinetic parameters associated with the maximum therapeutic efficacy in patients that have creatinine clearance above 130 ml/min.
|
Up to 12 months after the antibiotic administration
|
Determine the Ceftolozane-Tazobactam seric concentrations and analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with morbid obesity.
Time Frame: Up to 12 months after the antibiotic administration
|
Determination of the Ceftolozane-Tazobactam seric concentration by collecting 4 blood samples and measuring its antibiotic levels and if with both dose regimens are achieve the pharmacodynamic and pharmacokinetic parameters associated with the maximum therapeutic efficacy in patients that have BMI (body mass index) above 40
|
Up to 12 months after the antibiotic administration
|
Determine the Ceftolozane-Tazobactam seric concentrations and analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with continuous renal replacement technique.
Time Frame: Up to 12 months after the antibiotic administration
|
Determination of the Ceftolozane-Tazobactam seric concentration by collecting 4 blood samples and measuring its antibiotic levels and if with both dose regimens are achieve the pharmacodynamic and pharmacokinetic parameters associated with the maximum therapeutic efficacy in patients that have their blood purified extracorporeally, replacing the renal function continuously 24 hours of the day.
|
Up to 12 months after the antibiotic administration
|
Determine if in patients with Gram-negative bacillary bacteremia are achieved concentrations that are 100 % of the time 4 times above the minimum inhibitory concentration (MIC).
Time Frame: Up to 12 months after the antibiotic administration
|
Determination of if in patients with Gram-negative bacillary bacteremia (patients with their bloodstream invaded by Gram-negative bacillary which is diagnosed by blood culture) are achieved concentrations that are 100 % of the time 4 times above the MIC by strips of isolated pathogen gradient .
|
Up to 12 months after the antibiotic administration
|
Determine by a Monte Carlo simulation model the dose regimen that should be used.
Time Frame: Up to 12 months after the antibiotic administration
|
Determination by a Monte Carlo simulation model of the dose regimen that should be used based on the pharmacokinetic parameters and according to the defined efficacy pharmacodynamic parameters.
|
Up to 12 months after the antibiotic administration
|
Describe the frequency of resistance´s development during the Ceftolozane-Tazobactam treatment and, if it´s possible to evaluate if there´s a correlation with the seric levels.
Time Frame: Up to 12 months after the antibiotic administration
|
Description of the rate of resistance´s development during the Ceftolozane-Tazobactam and if there´s a correlation with the Ceftolozane-Tazobactam seric levels.
|
Up to 12 months after the antibiotic administration
|
Describe the Ceftolozane-Tazobactam treatment´s clinical result as well as existence of adverse effects.
Time Frame: Up to 12 months after the antibiotic administration
|
Description of the Ceftolozane-Tazobactam clinical results as well as the rate and seriousness of adverse effects.
|
Up to 12 months after the antibiotic administration
|
Collaborators and Investigators
Investigators
- Principal Investigator: José Garnacho Montero, Hospital Universitario Virgen Macarena
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIS-CEF-2019-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Serious Infection
-
Theravance BiopharmaCompletedSerious Infections Due to Known or Suspected Gram-positive PathogensUnited States
-
Taipei Medical University WanFang HospitalUnknownSerious Gram-positive InfectionsTaiwan
-
PfizerAllerganTerminatedSerious Bacterial InfectionRomania, Taiwan, China, Malaysia, Thailand, Philippines, Argentina, Greece, India, United States, Mexico, Russian Federation
-
Comenius UniversityCompletedSerious ConcernsSlovakia
-
Boston Children's HospitalThe Hospital for Sick Children; University of California, San Francisco; Children... and other collaboratorsCompletedSerious Medical Errors | Resident Sign-outUnited States, Canada
-
University of ZurichCompletedSerious Complications Following Liver ResectionSwitzerland
-
Shanghai Jiao Tong University School of MedicineCompletedEducational Problems | Serious Game | Augmented RealityChina
-
University Hospital, Basel, SwitzerlandStanley Thomas Johnson StiftungCompleted
-
Acibadem UniversityRecruitingVirtual Reality | Serious Game | Advanced Cardiac Life SupportTurkey
-
University of Wisconsin, MadisonUniversity of Alabama at Birmingham; National Institute on Aging (NIA); University... and other collaboratorsEnrolling by invitationCommunication | Serious InjuryUnited States
Clinical Trials on Ceftolozane/tazobactam
-
Cubist Pharmaceuticals LLCCompletedProven or Suspected Gram-negative Bacterial Infection | Peri-operative Prophylaxis
-
Cubist Pharmaceuticals LLCCompleted
-
Weill Medical College of Cornell UniversityMerck Sharp & Dohme LLCRecruitingPneumonia | Hematologic Malignancy | Pseudomonas AeruginosaUnited States
-
Cubist Pharmaceuticals LLCTerminatedVentilator-Associated Pneumonia (VAP)United States, Australia, New Zealand
-
Beneficência Portuguesa de São PauloMerck Sharp & Dohme LLCNot yet recruiting
-
Temple UniversityUnknownPseudomonas Infections | Pseudomonas AeruginosaUnited States
-
Hamad Medical CorporationMerck Sharp & Dohme LLCWithdrawnHematologic Cancer | Neutropenia, FebrileQatar
-
The University of QueenslandMerck Sharp & Dohme LLCWithdrawnBacteremia Caused by Gram-Negative BacteriaSpain, Australia, Singapore, Italy, Saudi Arabia
-
Sunshine Coast Hospital and Health ServiceThe Prince Charles Hospital; MaterNot yet recruitingBronchiectasis | Cystic Fibrosis | Pseudomonas Aeruginosa | Burkholderia Cepacia Infection
-
Merck Sharp & Dohme LLCCompletedPyelonephritis | Complicated Urinary Tract InfectionUnited States, Mexico, Russian Federation, Turkey, Greece, Hungary, Poland, Romania, South Africa, Ukraine