InfectionPhase 12 CefNCT01121354
Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX
A Phase 1 study testing Cefazolin 2g for Injection USP and Dextrose Injection USP and Cefazolin 1.5g in people with Infection, run by B. Braun Medical Inc. at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin 1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult subjects for 11 days of administration. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Cefazolin 2g for Injection USP and Dextrose Injection USP and Cefazolin 1.5g
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Feb 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects, male and female
- Age: 18 - 70 years (inclusive) at the time of screening.
- Females of non-child bearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal >= 1 year with follicle stimulating hormone [FSH] > 40 U/L).
- Healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory evaluations).
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent and the Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to performing any of the screening procedures.
Who cannot join
- Known allergy or hypersensitivity to beta-lactam/cephalosporin antibiotics, corn products or any of the other ingredients of the Investigational Products
- Subjects with impaired renal function based on the Cockcroft-Gault formula using actual body weight, i.e. estimated creatinine clearance <= 80 mL/min (performed at Screening only)
- Body Mass Index (BMI) < 20.0 or > 30.0 kg/m^2
- Body Weight < 50.0 kg
- White Blood Count (WBC) < 3.5 x10^3/uL or > ULN
- absolute neutrophil count (ANC) < 1.5 x10^3/uL or > ULN
Show all 23Show fewer
- Alarine aminotransferase and aspartate aminotransferase > upper limit of normal
- Other laboratory tests that are outside the normal limits, considered by the investigator, to be clinically significant.
- Use of any medication on a chronic basis.
- Takes any medication which interferes with the study drug or study procedures including aminoglycosides, anticoagulants, and probenecids.
- Use of over the counter (OTC) medications (including vitamins), prescription medications, or herbal remedies from 14 days prior to Day -1 until end of study. By exception, acetaminophen <= 1 gram per day is permitted.
- Tobacco use during the last 2 months prior to enrollment.
- Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
- Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at Screening or Day -1
- Positive blood test for ethanol at screening or Day -1.
- At screening, the subject has a clinically relevant ECG change, as assessed by the PI or designee.
- Concurrent acute or chronic infections (e.g. viral infections, except chronic recurrent herpes infections)
- History of or ongoing alcohol abuse or drug abuse (within last 2 years).
- Received an Investigational drug or device within 30 days of first dose of study drug
- Clinically relevant medical conditions which are likely to interfere with the evaluation of the trial drug, e.g. COPD, metabolic disorders (such as clinical and sub-clinical diabetes mellitus), history of malignant diseases (within last 5 years), autoimmune diseases, and cardiovascular disease
- Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements
- Any condition that, in the opinion of the principal investigator, would compromise the safety of the patient or the quality of the data
- Unable or unwilling to adhere to the study-specified procedures and restrictions
Trial locations and contacts
1 site in 1 country.
United States1 site
PAREXEL Early Phase Clinical Unit
Baltimore, Maryland, 21225
About this study
Official title: A Phase I Multiple-Dose Two-Arm Study to Evaluate the PK and Safety of Cefazolin 2g for Inj. USP and Dextrose Inj. USP in the DUPLEX® Drug Delivery System and Cefazolin for Inj. 1.5g in Daily Doses of 6g in Healthy Adult Subjects
The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin 1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult subjects for 11 days of administration.
Read the detailed description
- Braun Medical Inc. intends to conduct human PK studies and obtain marketing approval for Cefazolin 2g in the United States with identical indications of those already approved for the 1g strength. A pharmacokinetic study will be conducted with the Cefazolin 2g product manufactured by B. Braun Medical Inc. Cefazolin 1.5g dose will be prepared using 10g Cefazolin pharmacy bulk with 5% Dextrose. The clinical study proposed in this protocol is designed to evaluate the pharmacokinetic characteristics of 2g and 1.5g Cefazolin in Dextrose in healthy subjects at the maximum recommended infusion dose of 6g per day per FDA's recommendation.
The study is designed to simulate clinical practice and overall experience with cephalosporin administration. Cefazolin may be reconstituted with dextrose (or a number of other diluents as recommended in the innovator's package insert) in order to achieve an osmolality appropriate for intravenous infusion.
According to B. Braun's approved package insert for Cefazolin 1g, the maximum dose of 1.5g Cefazolin for Injection USP and Dextrose Injection USP is 1.5 grams every 6 hours for severe, life-threatening infections. In rare instances, doses of up to 12 grams of Cefazolin per day have been used. Lower doses are stated in the B. Braun package insert.
- Conditions
- Infection
- Being tested
- Cefazolin 2g for Injection USP and Dextrose Injection USP, Cefazolin 1.5g
- Keywords
- Cefazolin, Caphalosporin, antibiotic, gram positive, Infection control
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin 2g for Injection USP and Dextrose Injection USPDrug
Also called Cefazolin 2g in DUPLEX (50ml)
Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur three times per day (t.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.
Cefazolin 1.5gDrug
Also called Cefazolin 1.5g (50ml)
Cefazolin 1.5g for Injection USP and Dextrose Injection USP in a pharmacy-prepared container. Administration will occur four times per day (q.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin 2g (Test) | Experimental | Not described Receives: Drug: Cefazolin 2g for Injection USP and Dextrose Injection USP |
| Cefazolin 1.5g (Control) | Active comparator | Not described Receives: Drug: Cefazolin 1.5g |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g in a similar population of healthy adult subjects
The primary objective is to evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g for injection USP and Dextrose injection USP in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g for injection USP and Dextrose injection USP in a similar population of healthy adult subjects.
Measured: PK is evaluated on Days 1 and 11 of infusion therapy
Secondary outcomes (1)
To evaluate the safety of cefazolin 2g injection in total daily doses of 6g over 11 days of administration in healthy volunteers
- Hematology(CBC): Hb, Hct, RBC count, RBC indices, RBC morphology, platelet count, WBC count, and differential WBC
- Clinical Chemistry: Sodium, potassium, chloride, Co2, glucose, ALT, AST, alkaline phosphatase, serum albumin, total bilirubin, blood urea nitrogen, and creatinine
- Urinalysis: specific gravity, protein, blood, nitrates, leukocyte esterase, glucose, ketone, appearance, pH
- Urine drug and blood alcohol tests
- C. difficile
- ECG
- Vital signs: temperature, blood pressure, heart rate, and respiratory rate
- Adverse Events
- Physical exams
Measured: Varies, over 11 days of infusion therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Azra Hussaini, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121354
- Sponsor's protocol ID
- HC-G-H-0906
- Acronym
- 2 Cef
- Status last verified
- Jul 2013
- First submitted
- 10 May 2010
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Abraxis Pharmaceutical Products, Package Insert, Cefazolin for Injection, USP.45858E, July 2006, Schaumburg, IL 60173 (USA).
Apotex Corp., Package Insert, Cefazolin for Injection, USP, Pharmacy Bulk Pack. 948025398, December 2005, Weston, FL 33326 (USA).
APP Pharmaceuticals, LLC. Package Insert, Cefazolin for Injection, USP. 451180, July 2008, Schaumburg, IL 60173 (USA).
Hospira, Inc. Package Insert, Cefazolin for Injection, USP, Pharmacy Bulk Pack. EN-1961/948025777, December 2008, Lake Forest, IL 60045 (USA).
B. Braun Medical inc., Package Insert, Cefazolin for Injection USP and Dextrose Injection USP in DUPLEX Container, 1g, Apr 2008, Allentown, PA 18109 (USA).
Vella-Brincat JW, Begg EJ, Kirkpatrick CM, Zhang M, Chambers ST, Gallagher K. Protein binding of cefazolin is saturable in vivo both between and within patients. Br J Clin Pharmacol. 2007 Jun;63(6):753-7. doi: 10.1111/j.1365-2125.2006.02827.x. Epub 2007 Jan 12.
PubMed 17223858
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multiple-Dose Two-Arm Study to Evaluate the PK and Safety of Cefazolin 2g for Inj. USP and Dextrose Inj. USP in the DUPLEX® Drug Delivery System and Cefazolin for Inj. 1.5g in Daily Doses of 6g in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01121354
- Acronym / sponsor ID
- 2 Cef / HC-G-H-0906
- Conditions
- Infection
- Keywords
- Cefazolin, Caphalosporin, antibiotic, gram positive, Infection control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- B. Braun Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 12 May 2010 (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.
The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin 1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult subjects for 11 days of administration.
Detailed description
- Braun Medical Inc. intends to conduct human PK studies and obtain marketing approval for Cefazolin 2g in the United States with identical indications of those already approved for the 1g strength. A pharmacokinetic study will be conducted with the Cefazolin 2g product manufactured by B. Braun Medical Inc. Cefazolin 1.5g dose will be prepared using 10g Cefazolin pharmacy bulk with 5% Dextrose. The clinical study proposed in this protocol is designed to evaluate the pharmacokinetic characteristics of 2g and 1.5g Cefazolin in Dextrose in healthy subjects at the maximum recommended infusion dose of 6g per day per FDA's recommendation.
The study is designed to simulate clinical practice and overall experience with cephalosporin administration. Cefazolin may be reconstituted with dextrose (or a number of other diluents as recommended in the innovator's package insert) in order to achieve an osmolality appropriate for intravenous infusion.
According to B. Braun's approved package insert for Cefazolin 1g, the maximum dose of 1.5g Cefazolin for Injection USP and Dextrose Injection USP is 1.5 grams every 6 hours for severe, life-threatening infections. In rare instances, doses of up to 12 grams of Cefazolin per day have been used. Lower doses are stated in the B. Braun package insert.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin 2g (Test) | Experimental | Drug: Cefazolin 2g for Injection USP and Dextrose Injection USP |
| Cefazolin 1.5g (Control) | Active comparator | Drug: Cefazolin 1.5g |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy subjects, male and female
- Age: 18 - 70 years (inclusive) at the time of screening.
- Females of non-child bearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal >= 1 year with follicle stimulating hormone [FSH] > 40 U/L).
- Healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory evaluations).
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent and the Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to performing any of the screening procedures.
Key exclusion criteria (23 listed)
- Known allergy or hypersensitivity to beta-lactam/cephalosporin antibiotics, corn products or any of the other ingredients of the Investigational Products
- Subjects with impaired renal function based on the Cockcroft-Gault formula using actual body weight, i.e. estimated creatinine clearance <= 80 mL/min (performed at Screening only)
- Body Mass Index (BMI) < 20.0 or > 30.0 kg/m^2
- Body Weight < 50.0 kg
- White Blood Count (WBC) < 3.5 x10^3/uL or > ULN
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 |
|---|---|---|
| Cefazolin 2g for Injection USP and Dextrose Injection USPAlso: Cefazolin 2g in DUPLEX (50ml)Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur three times per day (t.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing. | Drug | Cefazolin 2g (Test) |
| Cefazolin 1.5gAlso: Cefazolin 1.5g (50ml)Cefazolin 1.5g for Injection USP and Dextrose Injection USP in a pharmacy-prepared container. Administration will occur four times per day (q.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing. | Drug | Cefazolin 1.5g (Control) |
Primary outcome
To evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g in a similar population of healthy adult subjects
Time frame: PK is evaluated on Days 1 and 11 of infusion therapy
The primary objective is to evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g for injection USP and Dextrose injection USP in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g for injection USP and Dextrose injection USP in a similar population of healthy adult subjects.
1 secondary outcome
To evaluate the safety of cefazolin 2g injection in total daily doses of 6g over 11 days of administration in healthy volunteers
Time frame: Varies, over 11 days of infusion therapy
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 16 Jul 2013.
- BackgroundAbraxis Pharmaceutical Products, Package Insert, Cefazolin for Injection, USP.45858E, July 2006, Schaumburg, IL 60173 (USA).
- BackgroundApotex Corp., Package Insert, Cefazolin for Injection, USP, Pharmacy Bulk Pack. 948025398, December 2005, Weston, FL 33326 (USA).
- BackgroundAPP Pharmaceuticals, LLC. Package Insert, Cefazolin for Injection, USP. 451180, July 2008, Schaumburg, IL 60173 (USA).
- BackgroundHospira, Inc. Package Insert, Cefazolin for Injection, USP, Pharmacy Bulk Pack. EN-1961/948025777, December 2008, Lake Forest, IL 60045 (USA).
- BackgroundB. Braun Medical inc., Package Insert, Cefazolin for Injection USP and Dextrose Injection USP in DUPLEX Container, 1g, Apr 2008, Allentown, PA 18109 (USA).
- Background: PubMed 17223858Vella-Brincat JW, Begg EJ, Kirkpatrick CM, Zhang M, Chambers ST, Gallagher K. Protein binding of cefazolin is saturable in vivo both between and within patients. Br J Clin Pharmacol. 2007 Jun;63(6):753-7. doi: 10.1111/j.1365-2125.2006.02827.x. Epub 2007 Jan 12.
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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.
Azra Hussaini, MD principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cefazolin 2g for Injection USP and Dextrose Injection USP and Cefazolin 1.5g in people with Infection, run by B. Braun Medical Inc. 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 23 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 16 Jul 2013. 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 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?
To evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g in a similar population of healthy adult subjects (time frame: PK is evaluated on Days 1 and 11 of infusion therapy). 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 NCT01121354, which also lists 6 linked publications.
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 16 Jul 2013.