Augmented Renal Clearance (ARC)Phase 1NCT01624246
Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
A Phase 1 study testing Ceftaroline fosamil/Avibactam (CXL) in people with Augmented Renal Clearance (ARC) and Systemic Inflammatory Response Syndrome (SIRS), run by Forest Laboratories at 21 sites in 2 countries.
Trial summary
To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Augmented Renal Clearance (ARC), Systemic Inflammatory Response Syndrome (SIRS)
- What is being tested?
- Ceftaroline fosamil/Avibactam (CXL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 21 sitesin 2 countries
- Study dates
- May 2012to Mar 2013
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adults ≥ 18 and ≤ 55 years old
- Augmented renal clearance, defined as:
- Estimated CrCl ≥ 115 mL/min (calculated using modified Cockcroft-Gault, before the measured 8-hour urine collection)
- Measured CrCl ≥ 140 mL/min (from an 8-hour urine collection)
- Hospitalized and diagnosed with SIRS, defined by at least 2 of the following:
- Temperature (oral, rectal, tympanic, or core) > 38.5°C or < 35.0°C
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- Heart rate > 90 beats/min
- Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg
- Leukocytosis (> 12,000 white blood cells [WBC]/mm3), leukopenia (< 4000 WBC/mm3), or bandemia (> 10% immature neutrophils [bands] regardless of total peripheral WBC)
- Requires indwelling urinary bladder catheter per standard of care (through the end of the 8-hour urine collection)
Who cannot join
- History of any known hypersensitivity or allergic reaction to cephalosporins or any β-lactam antimicrobial (eg, penicillins)
- History of chronic kidney disease, hemodialysis, or peritoneal dialysis; or history of acute renal replacement therapy (eg, hemodialysis, hemofiltration) associated with current illness
- Suspected rhabdomyolysis or creatine kinase > 10,000 U/L
- Significant anemia defined as hemoglobin < 9 g/dL or hematocrit < 27%
- Transfusion of packed red blood cells (PRBC) or whole blood within 24 hours of study drug infusion or anticipated need for a transfusion before the last PK blood sample is collected
- If female, currently pregnant or breastfeeding
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
Investigational Site
Chicago, Illinois, 60612
Investigational Site
Cleveland, Ohio, 44106
Investigational Site
Columbus, Ohio, 43210
Investigational Site
Dayton, Ohio, 45409
Investigational Site
Duluth, Minnesota, 55805
Investigational Site
Fresno, California, 93711
Investigational Site
Gainesville, Florida, 32610
Investigational Site
Hartford, Connecticut, 06102
Investigational Site
Houston, Texas, 77401
Investigational Site
Los Angeles, California, 90033
Investigational Site
Maywood, Illinois, 60153
Investigational Site
Miami, Florida, 33136
Investigational Site
Neptune City, New Jersey, 07753
Investigational Site
Omaha, Nebraska, 68131
Investigational Site
Peoria, Illinois, 61606
Investigational Site
San Diego, California, 92123
Investigational Site
Stanford, California, 94605
Investigational Site
Washington D.C., District of Columbia, 20010
Investigational Site
Winston-Salem, North Carolina, 27157
Australia2 sites
Investigational Site
Herston, Queensland, 4029
Investigational Site
Southport, Queensland, 4215
About this study
Official title: A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).
Read the detailed description
To evaluate the single-dose pharmacokinetic (PK) profiles of ceftaroline and avibactam following intravenous (IV) administration of ceftaroline fosamil/avibactam ("CXL") in adults with augmented renal clearance (ARC).
- Being tested
- Ceftaroline fosamil/Avibactam (CXL)
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftaroline fosamil/Avibactam (CXL)Drug
IV infusion of CXL (combination of ceftaroline fosamil [600 mg] plus avibactam [600 mg]) infused over 60 (± 5) minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline fosamil/Avibactam | Experimental | Not described Receives: Drug: Ceftaroline fosamil/Avibactam (CXL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss.
The following PK parameters, if calculable, will be determined for ceftaroline, ceftaroline fosamil, ceftaroline M-1, and avibactam: area under the plasma concentration versus time curve, Cmax, time of maximum plasma drug concentration (Tmax), T½, apparent total body clearance of drug from plasma (CL), apparent volume of distribution during the terminal phase (Vz), and Vss.
Measured: Up to 3 days
Secondary outcomes (1)
Safety and Tolerability of a Single Dose of IV Ceftaroline fosamil and Avibactam.
Adverse events will be summarized. Vital signs (pulse, blood pressure, respiratory rate, temperature), oxygen saturation and concomitant medications will be summarized. Complete blood count (CBC) and comprehensive metabolic panel results will be summarized.
Measured: 24-36 hours after last study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Augmented Renal Clearance (ARC)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624246
- Sponsor's protocol ID
- CXL-PK-04
- Status last verified
- Apr 2017
- First submitted
- 14 Jun 2012
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
PubMed 30221827
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
- ClinicalTrials.gov ID
- NCT01624246
- Acronym / sponsor ID
- CXL-PK-04
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Jun 2012 (estimated)
- 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.
To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).
Detailed description
To evaluate the single-dose pharmacokinetic (PK) profiles of ceftaroline and avibactam following intravenous (IV) administration of ceftaroline fosamil/avibactam ("CXL") in adults with augmented renal clearance (ARC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftaroline fosamil/Avibactam | Experimental | Drug: Ceftaroline fosamil/Avibactam (CXL) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female adults ≥ 18 and ≤ 55 years old
- Augmented renal clearance, defined as:
- Hospitalized and diagnosed with SIRS, defined by at least 2 of the following:
- Requires indwelling urinary bladder catheter per standard of care (through the end of the 8-hour urine collection)
Key exclusion criteria (6 listed)
- History of any known hypersensitivity or allergic reaction to cephalosporins or any β-lactam antimicrobial (eg, penicillins)
- History of chronic kidney disease, hemodialysis, or peritoneal dialysis; or history of acute renal replacement therapy (eg, hemodialysis, hemofiltration) associated with current illness
- Suspected rhabdomyolysis or creatine kinase > 10,000 U/L
- Significant anemia defined as hemoglobin < 9 g/dL or hematocrit < 27%
- Transfusion of packed red blood cells (PRBC) or whole blood within 24 hours of study drug infusion or anticipated need for a transfusion before the last PK blood sample is collected
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 |
|---|---|---|
| Ceftaroline fosamil/Avibactam (CXL)IV infusion of CXL (combination of ceftaroline fosamil [600 mg] plus avibactam [600 mg]) infused over 60 (± 5) minutes. | Drug | Ceftaroline fosamil/Avibactam |
Primary outcome
Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss.
Time frame: Up to 3 days
The following PK parameters, if calculable, will be determined for ceftaroline, ceftaroline fosamil, ceftaroline M-1, and avibactam: area under the plasma concentration versus time curve, Cmax, time of maximum plasma drug concentration (Tmax), T½, apparent total body clearance of drug from plasma (CL), apparent volume of distribution during the terminal phase (Vz), and Vss.
1 secondary outcome
Safety and Tolerability of a Single Dose of IV Ceftaroline fosamil and Avibactam.
Time frame: 24-36 hours after last study procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Derived from this study: PubMed 30221827Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
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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.
Medical Monitor study director
Forest Laboratories
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ceftaroline fosamil/Avibactam (CXL) in people with Augmented Renal Clearance (ARC) and Systemic Inflammatory Response Syndrome (SIRS), run by Forest Laboratories at 21 sites in 2 countries.
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 10 inclusion and 6 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: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma Pharmacokinetic Parameters of Ceftaroline and Avibactam: Area under the plasma concentration versus time curve, Cmax, Tmax, T½, , CL, Vz, and Vss. (time frame: Up to 3 days). 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 NCT01624246, 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 7 Apr 2017.