BurnsPhase 4NCT03002506
Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns
A Phase 4 study testing Ceftolozane/tazobactam in people with Burns and Pharmacokinetics, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
This study will help provide information about how patients with burn handle two antibiotics (ceftolozane and tazobactam) and use that information to guide dosing recommendations for these patients. The 12 patients who complete the study will receive a single dose of 3 grams ceftolozane/tazobactam intravenously. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burns, Pharmacokinetics
- What is being tested?
- Ceftolozane/tazobactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 30 Jun 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, ages 18-80 years, of all racial and ethnic origins.
- Non-English Spanish speakers will be included in the study.
- We are recruiting 12 patients with thermal burn injuries (percent total body surface area burned >/= 20%). Patients will be at least five days from the date of the burn injury.
- Patients will have central venous or arterial line access.
- Patients will be already be receiving standard of care antimicrobial therapy for a suspected infection.
Who cannot join
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of ceftolozane and tazobactam on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ceftolozane and tazobactam, so that the pregnancy and post-partum state would be a confounding variable.
- Abnormal liver function tests: transaminases >10 times upper limit of normal, Alkaline phosphatase >5 times upper limit of normal, total bilirubin >5 times upper limit of normal.
- History of allergies to beta-lactam antibiotics.
- Patients unwilling to comply with study procedures.
- Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by principal investigator (PI).
- Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
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- Creatinine clearance < 30 ml/min as estimated by the Cockcroft-Gault equation.
- Patients who are receiving piperazillin/tazobactam or have received piperacillin/tazobactam within the past 48 hours.
- Patients who are receiving vasopressors.
- Patients with a total body weight < 60 kg or > 130 kg.
Trial locations and contacts
1 site in 1 country.
About this study
This study will help provide information about how patients with burn handle two antibiotics (ceftolozane and tazobactam) and use that information to guide dosing recommendations for these patients. The 12 patients who complete the study will receive a single dose of 3 grams ceftolozane/tazobactam intravenously. We will collect blood and urine samples to determine how much of each antibiotic is in the body and urine at various times over a 24 hour period. This information will be used with previously published information from microbiology laboratories to perform simulations that will provide recommendations on optimal dosing recommendations of these antibiotics in patients with burns.
Read the detailed description
A single dose pharmacokinetic study of ceftolozane and tazobactam will be conducted in patients with burns at the Burn Center at University Medical Center. A total of 12 adults aged 18 to 80 years with >/= 20% percent total body surface area burned will be required to complete the study. A single intravenous dose of ceftolozane and tazobactam of 2 grams/1 gram will be administered over 60 minutes and whole blood will be obtained predose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours following the start of infusion. Urine samples (5 ml) will be collected from a urine collection bag (if the patient has urinated) at the following timepoints: 0-0.5, 0.5-1, 1-2, 2-4, 4-8, 8-12, and 12-24 hours for analysis of ceftolozane and tazobactam content. Urine for collected during each time period will be measured to determine urine volume for urine clearance calculations. The volume of urine in the urine over the entire 24 hour period and an aliquot sent for analysis of urine creatinine content to determine the patient's 24 hour creatinine clearance.
- Conditions
- Burns, Pharmacokinetics
- Being tested
- Ceftolozane/tazobactam
- Keywords
- ceftolozane, tazobactam
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftolozane/tazobactamDrug
Also called Zerbaxa
Single dose of 2 grams/1 gram intravenously administered over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| ceftolozane/tazobactam | Experimental | One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant. Receives: Drug: Ceftolozane/tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ceftolozane Clearnace
Liters/hour (continuous values)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start21 Aug 2017
- Primary completion1 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Much slower recruitment than anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Ronald G Hall, PharmD, Principal investigator, Texas Tech University HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002506
- Sponsor's protocol ID
- 070619
- Status last verified
- Mar 2021
- First submitted
- 21 Dec 2016
- Last updated
- 2 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hall RG 2nd, Hooper L, Dissanaike S, Griswold JA, Kallem RR, Subramaniyan I, Putnam WC, Pai MP. Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Partial- and Full-Thickness Skin Burns. Pharmacotherapy. 2025 Nov;45(11):774-779. doi: 10.1002/phar.70076. Epub 2025 Nov 10.
PubMed 41212678
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns
- ClinicalTrials.gov ID
- NCT03002506
- Acronym / sponsor ID
- 070619
- Conditions
- Burns, Pharmacokinetics
- Keywords
- ceftolozane, tazobactam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Much slower recruitment than anticipated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Posted 2 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will help provide information about how patients with burn handle two antibiotics (ceftolozane and tazobactam) and use that information to guide dosing recommendations for these patients. The 12 patients who complete the study will receive a single dose of 3 grams ceftolozane/tazobactam intravenously. We will collect blood and urine samples to determine how much of each antibiotic is in the body and urine at various times over a 24 hour period. This information will be used with previously published information from microbiology laboratories to perform simulations that will provide recommendations on optimal dosing recommendations of these antibiotics in patients with burns.
Detailed description
A single dose pharmacokinetic study of ceftolozane and tazobactam will be conducted in patients with burns at the Burn Center at University Medical Center. A total of 12 adults aged 18 to 80 years with >/= 20% percent total body surface area burned will be required to complete the study. A single intravenous dose of ceftolozane and tazobactam of 2 grams/1 gram will be administered over 60 minutes and whole blood will be obtained predose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours following the start of infusion. Urine samples (5 ml) will be collected from a urine collection bag (if the patient has urinated) at the following timepoints: 0-0.5, 0.5-1, 1-2, 2-4, 4-8, 8-12, and 12-24 hours for analysis of ceftolozane and tazobactam content. Urine for collected during each time period will be measured to determine urine volume for urine clearance calculations. The volume of urine in the urine over the entire 24 hour period and an aliquot sent for analysis of urine creatinine content to determine the patient's 24 hour creatinine clearance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ceftolozane/tazobactam | Experimental | Drug: Ceftolozane/tazobactamOne dose of 3 grams ceftolozane/tazobactam will be administered to each study participant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects, ages 18-80 years, of all racial and ethnic origins.
- Non-English Spanish speakers will be included in the study.
- We are recruiting 12 patients with thermal burn injuries (percent total body surface area burned >/= 20%). Patients will be at least five days from the date of the burn injury.
- Patients will have central venous or arterial line access.
- Patients will be already be receiving standard of care antimicrobial therapy for a suspected infection.
Key exclusion criteria (10 listed)
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of ceftolozane and tazobactam on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ceftolozane and tazobactam, so that the pregnancy and post-partum state would be a confounding variable.
- Abnormal liver function tests: transaminases >10 times upper limit of normal, Alkaline phosphatase >5 times upper limit of normal, total bilirubin >5 times upper limit of normal.
- History of allergies to beta-lactam antibiotics.
- Patients unwilling to comply with study procedures.
- Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by principal investigator (PI).
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 |
|---|---|---|
| Ceftolozane/tazobactamAlso: ZerbaxaSingle dose of 2 grams/1 gram intravenously administered over 60 minutes. | Drug | ceftolozane/tazobactam |
Primary outcome
Ceftolozane Clearnace
Time frame: 24 hours
Liters/hour (continuous values)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41212678Hall RG 2nd, Hooper L, Dissanaike S, Griswold JA, Kallem RR, Subramaniyan I, Putnam WC, Pai MP. Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Partial- and Full-Thickness Skin Burns. Pharmacotherapy. 2025 Nov;45(11):774-779. doi: 10.1002/phar.70076. Epub 2025 Nov 10.
- Individual participant dataSharing planned: No
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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.
Ronald G Hall, PharmD principal investigator
Texas Tech University HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftolozane/tazobactam in people with Burns and Pharmacokinetics, run by Texas Tech University Health Sciences Center at 1 site in United States.
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: stopped early, as of the sponsor's last update on 2 Mar 2021. 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 States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ceftolozane Clearnace (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002506, which also lists 1 linked publication.
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 2 Mar 2021.