InfectionsPhase 1NCT01904357
Pediatric Cefazolin PK Study
A Phase 1 study testing Cefazolin 1 GM Injection and Cefazolin 2 GM Injection in people with Infections, run by B. Braun Medical Inc. at 2 sites in United States.
Trial summary
The primary objective of this study is: To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Infections
- What is being tested?
- Cefazolin 1 GM Injection and Cefazolin 2 GM Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Sep 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 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects of 10 to 12 years (inclusive) at the time of screening and who are scheduled for any type of surgery requiring single-dose perioperative cefazolin prophylaxis
- The subject and the subject's Legal Authorized Representative (LAR) voluntarily agree that the subject will participate in this study and the LAR signs an Institutional Review Board-approved informed consent and Health Insurance Portability and Accountability Act Authorization prior to the performance of any of the screening procedures
Who cannot join
- Known allergy or hypersensitivity to beta-lactam/cephalosporin antibiotics, corn or dextrose- containing products or solutions or any of the other ingredients of the Investigational Product (IP)
- Pregnant or nursing females
- Subjects with impaired renal function based on the Revised Schwartz Formula using actual body height, i.e., estimated creatinine clearance ≤ 80 mL/minute/1.73m2 (performed at Screening only if test results are not available within 3 months prior to the planned surgical procedure); the Schwartz GFR is:
- GFR = 0.41 x height (cm)
- Serum creatinine (mg/dL)
- Have surgery scheduled and planned to last > 3 hours
Show all 17Show fewer
- Body Weight <25.0 kg or > 85.0 kg
- Other laboratory tests, obtained as standard of care, that are outside the normal limits according to site's laboratory reference ranges or are considered by the Investigator, to be clinically significant
- Administration of cefazolin within the past seven days
- Administration of any medication (e. g., prescription, herbal, over-the-counter medication(s) or dietary supplements) or medication known to interact with the cefazolin that might interfere with the study drug or study procedures
- Prior medical history of human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
- Alcohol abuse or drug abuse
- Received an investigational drug/device within 30 days of the first dose of study drug
- Clinically relevant medical condition(s) likely to interfere with the evaluation of the trial drug (e.g., pulmonary disease, metabolic disorders, active malignant disease, 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 (s) that in the opinion of the PI would compromise the safety of the subject or the quality of the data
- Unable or unwilling to adhere to the study-specified procedures and restrictions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arkansas Children's Hospital
Little Rock, Arkansas, 72205
Toledo Children's Hospital
Toledo, Ohio, 43606
About this study
Official title: USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in Pediatric Subjects of 10-12 Years (Inclusive) Scheduled for Surgery
The primary objective of this study is:
- To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
Read more
The secondary objectives of this study are:
- To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with modeling data for adolescents aged 13-17 years (inclusive) and historical data from adults receiving a single 2g dose of cefazolin.
- To assess the safety of a single dose of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
Read the detailed description
This is a multiple-center, open-label, PK study of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2 g of cefazolin delivered via the DUPLEX® drug delivery system for surgical prophylaxis. Surgery should be expected to last no longer than 3 hours. If a second dose of cefazolin is required, the subject will be excluded from the PK analysis and additional subjects will be enrolled if necessary to obtain eight evaluable subjects. The surgical procedures may be performed in an outpatient or inpatient setting but subjects must be available to complete the planned 8-hour PK sampling as noted below. Study drug will be administered by continuous infusion over a 30-minute period using an infusion pump. Based on weight at Day 1(Day of Surgery) (unless a weight assessment was obtained within the previous seven days that by physician judgment is felt to represent a stable weight and not have the potential to change such that the subject dose may be affected). Subjects weighing ≥25 kg and < 50 kg will receive the 1g dose. Subjects weighing ≥ 50 kg and ≤ 85 kg will receive the 2g dose. Dose groups will not be balanced by age or gender. The weight-based dosage regimen that will be employed for this study has been selected to assure that subjects will receive a dose between 20 and 40 mg/kg body weight, based on Monte Carlo simulations using adult PK data, which is consistent with current practice. Blood samples for determination of PK of cefazolin will be drawn at the following times: 15 minutes before the start of infusion (baseline), at the end of infusion, 15 and 30 minutes and 1 hour, 2 hours, 3 hours, 6 hours, and 8 hours after the end of the infusion for a total of nine blood samples. Safety will be assessed by monitoring adverse and serious adverse events based on patient history, vital signs, and physical examination. Follow-up phone calls will be placed to each subject one week post treatment to assess adverse events (AEs) and well-being.
- Conditions
- Infections
- Being tested
- Cefazolin 1 GM Injection, Cefazolin 2 GM Injection
- Keywords
- Cefazolin, Pediatric
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin 1 GM InjectionDrug
Subjects weighing ≥25 kg and < 50 kg will receive the 1g dose.
Cefazolin 2 GM InjectionDrug
Subjects weighing ≥50 kg to ≤85 kg will receive the 2g dose.
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin 1 GM Injection | Active comparator | Subjects weighing ≥25 kg and < 50 kg will receive the 1g dose. Receives: Drug: Cefazolin 1 GM Injection |
| Cefazolin 2 GM Injection | Active comparator | Subjects weighing ≥50 kg to ≤85 kg will receive the 2g dose. Receives: Drug: Cefazolin 2 GM Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single dose study to evaluate the pharmacokinetics of Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in pediatric subjects of 10-12 years (inclusive) scheduled for surgery
To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
Measured: 8 hours
Secondary outcomes (2)
Single dose study to evaluate the pharmacokinetics of Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in pediatric subjects of 10-12 years (inclusive) scheduled for surgery
To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with modeling data for adolescents aged 13-17 years (inclusive) and historical data from adults receiving a single 2g dose of cefazolin.
•
Measured: 8 Days
Safety of Cefazolin Dose of 1g or 2 g in children aged 10-12 years of age
To assess the safety of a single dose of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael L Schmitz, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904357
- Sponsor's protocol ID
- HC-G-H-1202
- Status last verified
- Jul 2017
- First submitted
- 15 Jul 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nahata MC, Durrell DE, Ginn-Pease ME, King DR. Pharmacokinetics and tissue concentrations of cefazolin in pediatric patients undergoing gastrointestinal surgery. Eur J Drug Metab Pharmacokinet. 1991 Jan-Mar;16(1):49-52. doi: 10.1007/BF03189874.
PubMed 1936061Schmitz ML, Blumer JL, Cetnarowski W, Rubino CM. Determination of appropriate weight-based cutoffs for empiric cefazolin dosing using data from a phase 1 pharmacokinetics and safety study of cefazolin administered for surgical prophylaxis in pediatric patients aged 10 to 12 years. Antimicrob Agents Chemother. 2015 Jul;59(7):4173-80. doi: 10.1128/AAC.00082-15. Epub 2015 May 4.
PubMed 25941220
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in Pediatric Subjects of 10-12 Years (Inclusive) Scheduled for Surgery
- ClinicalTrials.gov ID
- NCT01904357
- Acronym / sponsor ID
- HC-G-H-1202
- Conditions
- Infections
- Keywords
- Cefazolin, Pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- B. Braun Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Jul 2013 (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 primary objective of this study is:
- To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
The secondary objectives of this study are:
- To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with modeling data for adolescents aged 13-17 years (inclusive) and historical data from adults receiving a single 2g dose of cefazolin.
- To assess the safety of a single dose of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
Detailed description
This is a multiple-center, open-label, PK study of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2 g of cefazolin delivered via the DUPLEX® drug delivery system for surgical prophylaxis. Surgery should be expected to last no longer than 3 hours. If a second dose of cefazolin is required, the subject will be excluded from the PK analysis and additional subjects will be enrolled if necessary to obtain eight evaluable subjects. The surgical procedures may be performed in an outpatient or inpatient setting but subjects must be available to complete the planned 8-hour PK sampling as noted below. Study drug will be administered by continuous infusion over a 30-minute period using an infusion pump. Based on weight at Day 1(Day of Surgery) (unless a weight assessment was obtained within the previous seven days that by physician judgment is felt to represent a stable weight and not have the potential to change such that the subject dose may be affected). Subjects weighing ≥25 kg and < 50 kg will receive the 1g dose. Subjects weighing ≥ 50 kg and ≤ 85 kg will receive the 2g dose. Dose groups will not be balanced by age or gender. The weight-based dosage regimen that will be employed for this study has been selected to assure that subjects will receive a dose between 20 and 40 mg/kg body weight, based on Monte Carlo simulations using adult PK data, which is consistent with current practice. Blood samples for determination of PK of cefazolin will be drawn at the following times: 15 minutes before the start of infusion (baseline), at the end of infusion, 15 and 30 minutes and 1 hour, 2 hours, 3 hours, 6 hours, and 8 hours after the end of the infusion for a total of nine blood samples. Safety will be assessed by monitoring adverse and serious adverse events based on patient history, vital signs, and physical examination. Follow-up phone calls will be placed to each subject one week post treatment to assess adverse events (AEs) and well-being.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin 1 GM Injection | Active comparator | Drug: Cefazolin 1 GM InjectionSubjects weighing ≥25 kg and < 50 kg will receive the 1g dose. |
| Cefazolin 2 GM Injection | Active comparator | Drug: Cefazolin 2 GM InjectionSubjects weighing ≥50 kg to ≤85 kg will receive the 2g dose. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female subjects of 10 to 12 years (inclusive) at the time of screening and who are scheduled for any type of surgery requiring single-dose perioperative cefazolin prophylaxis
- The subject and the subject's Legal Authorized Representative (LAR) voluntarily agree that the subject will participate in this study and the LAR signs an Institutional Review Board-approved informed consent and Health Insurance Portability and Accountability Act Authorization prior to the performance of any of the screening procedures
Key exclusion criteria (17 listed)
- Known allergy or hypersensitivity to beta-lactam/cephalosporin antibiotics, corn or dextrose- containing products or solutions or any of the other ingredients of the Investigational Product (IP)
- Pregnant or nursing females
- Subjects with impaired renal function based on the Revised Schwartz Formula using actual body height, i.e., estimated creatinine clearance ≤ 80 mL/minute/1.73m2 (performed at Screening only if test results are not available within 3 months prior to the planned surgical procedure); the Schwartz GFR is:
- Have surgery scheduled and planned to last > 3 hours
- Body Weight <25.0 kg or > 85.0 kg
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 1 GM InjectionSubjects weighing ≥25 kg and < 50 kg will receive the 1g dose. | Drug | Cefazolin 1 GM Injection |
| Cefazolin 2 GM InjectionSubjects weighing ≥50 kg to ≤85 kg will receive the 2g dose. | Drug | Cefazolin 2 GM Injection |
Primary outcome
Single dose study to evaluate the pharmacokinetics of Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in pediatric subjects of 10-12 years (inclusive) scheduled for surgery
Time frame: 8 hours
To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
2 secondary outcomes
Single dose study to evaluate the pharmacokinetics of Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in pediatric subjects of 10-12 years (inclusive) scheduled for surgery
Time frame: 8 Days
Safety of Cefazolin Dose of 1g or 2 g in children aged 10-12 years of age
Time frame: 8 days
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 21 Jul 2017.
- Background: PubMed 1936061Nahata MC, Durrell DE, Ginn-Pease ME, King DR. Pharmacokinetics and tissue concentrations of cefazolin in pediatric patients undergoing gastrointestinal surgery. Eur J Drug Metab Pharmacokinet. 1991 Jan-Mar;16(1):49-52. doi: 10.1007/BF03189874.
- Derived from this study: PubMed 25941220Schmitz ML, Blumer JL, Cetnarowski W, Rubino CM. Determination of appropriate weight-based cutoffs for empiric cefazolin dosing using data from a phase 1 pharmacokinetics and safety study of cefazolin administered for surgical prophylaxis in pediatric patients aged 10 to 12 years. Antimicrob Agents Chemother. 2015 Jul;59(7):4173-80. doi: 10.1128/AAC.00082-15. Epub 2015 May 4.
- 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.
Michael L Schmitz, MD principal investigator
Arkansas Children's Hospital Research Institute
2 sites 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 1 GM Injection and Cefazolin 2 GM Injection in people with Infections, run by B. Braun Medical Inc. at 2 sites 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 2 inclusion and 17 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Single dose study to evaluate the pharmacokinetics of Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in pediatric subjects of 10-12 years (inclusive) scheduled for surgery (time frame: 8 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 NCT01904357, which also lists 2 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 21 Jul 2017.