InfectionsPhase 13gCefPKNCT05205486
Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults
A Phase 1 study testing Cefazolin 3gm for Injection USP and Dextrose Injection USP in people with Infections, run by B. Braun Medical Inc. at 2 sites in United States.
Trial summary
This study is designed to evaluate the pharmacokinetics (PK) of a single 3 gm dose of cefazolin from a DUPLEX container, in adult subjects (weighing >/= 120 kg) scheduled for surgery. Cefazolin will be administered as a 30-minute intravenous (IV) infusion, per cefazolin Package Insert. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Cefazolin 3gm for Injection USP and Dextrose Injection USP
- 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
- 5 Apr 2022to 13 Jul 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged >/= 18 years;
- Must weigh >/= 120 kg
- Able to understand and sign the Informed Consent Form(s) (ICF);
- Is scheduled for surgery that is expected to last less than 3 hours;
- Is scheduled for any type of surgery where a single-dose perioperative cefazolin prophylaxis is appropriate.
Who cannot join
- If female, is pregnant or lactating/breastfeeding.
- If female that is of childbearing potential and sexually active, and is not using an effective method of birth control, e.g., oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or have a partner with a vasectomy.
- Has a history of renal impairment -- Subject has an eGFR of <80 mL/min/1.73m2 performed at Screening as calculated by the following equation: 186 x (Creatinine/88.4)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if black) (FDA Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function)
- Has a known allergy or hypersensitivity to β lactam/cephalosporin antibiotics, corn products, or dextrose-containing products or solutions, or any of the other ingredients of Cefazolin for Injection United States Pharmacopeia (USP) and Dextrose Injection USP in DUPLEX.
- Has a result of any laboratory test (or repeat test, if done), obtained as standard of care, that is outside the normal limit of the site's laboratory reference range AND is considered by the investigator to be clinically significant.
- Has had a recent (within 14 days prior to the planned surgery) administration of cefazolin.
Show all 17Show fewer
- Has had administration of any medication (e.g., prescription, herbal, over-the-counter medication[s] or dietary supplements) known to interact with cefazolin within 5 days prior to the study treatment administration.
- Has a known history of human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Has a current history of medical condition(s), which in the opinion of the investigator, would interfere with the evaluation of the study treatment.
- Has a known history of organ transplant.
- Has a clinically relevant disease/dysfunction of or a history of severe cardiac, pulmonary or hepatic disease.
- Is undergoing any cardiovascular procedure including, but not limited to, major cardiac surgery, cardiac catheterizations (including electrophysiology studies), ablations, automatic implantable cardioverter-defibrillator (AICD), and pacemaker.
- Has received any other investigational drug/device within 30 days prior to the study treatment administration.
- Has any planned medical intervention or personal event that might interfere with ability to comply with the study requirements.
- The subject has any condition that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data.
- Is unable or unwilling to adhere to the study-specified procedures and restrictions.
- Is an employee of the Sponsor, Investigator or study-center, has direct involvement in the study or other studies under the direction of that Investigator or study-center, or is a family member of the employees or the Investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
IACT Health - Roswell - IACT - HyperCore - PPDS
Columbus, Georgia, 31904
Hightower Clinical, LLC
Oklahoma City, Oklahoma, 73102
About this study
Official title: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of a Single 3 Gram Dose of Cefazolin in Adult Subjects Weighing >= 120 kg Scheduled for Surgery
This study is designed to evaluate the pharmacokinetics (PK) of a single 3 gm dose of cefazolin from a DUPLEX container, in adult subjects (weighing >/= 120 kg) scheduled for surgery. Cefazolin will be administered as a 30-minute intravenous (IV) infusion, per cefazolin Package Insert. Five PK samples per subject will be obtained up to 8 hours after dosing. These data will then be assessed by the validated Cefazolin PK Model to verify there are no significant PK changes within this study population.
Read the detailed description
This is a Phase 1, open-label, single-dose, multiple-center, study to determine the pharmacokinetics of a single 3 g dose of cefazolin administered as a 30 minute IV infusion prior to surgery in adult subjects weighing >/= 120 kg. Adult subjects will be enrolled in order to ensure at least 12 subjects complete the study. Enrollment will be competitive across the study sites. All subjects will have Screening and baseline evaluations performed to ensure their eligibility for the study The Screening Period is up to 30 days before administration of study drug on Day 1.
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). Planned surgical procedures may be performed outpatient or inpatient and are expected to last no longer than 3 hours.
If the surgery is extended unexpectedly beyond the 3-hour limit, additional doses of study drug are permitted according to institutional guidelines. PK blood sample collection will continue after the administration of an additional dose of cefazolin. Safety in this population will also be assessed.
All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min) and 8 h (+/-15 min).
Safety will be assessed by monitoring adverse events (AEs), physical examination, vital signs, and clinical laboratory tests. A follow-up visit will be performed on Day 8 (+/-1 day) for safety assessments.
A subject is considered a study completer if he/she has completed all study related procedures through the end of surgery and the required PK sample collections. It is highly preferred that the subjects also participate in the Day 8 (+/-1 day) Safety Follow-up. For subjects who withdraw or are withdrawn before study completion of the study, every effort will be made to perform all Safety Follow up procedures.
Any subject who withdraws or is withdrawn before collection of at least 4 of the 5 PK samples will not be consider as a PK completer. If necessary, additional subjects must be enrolled to ensure that there are at least 12 PK completers.
On Day 8 (+/-1 day), a Safety follow-up will be conducted. If this is an in-person visit, the following will be performed: vital signs, clinical laboratory tests, examination of the infusion site, review of AEs and concomitant medication. If an in-person visit is not possible, every effort will be made to contact the subject by phone and the subjects will be asked about any AEs and concomitant medication they may have taken.
- Conditions
- Infections
- Being tested
- Cefazolin 3gm for Injection USP and Dextrose Injection USP
- Keywords
- Cephalosporin, antibiotic, infection control, surgical prophylaxis
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin 3gm for Injection USP and Dextrose Injection USPDrug
Also called Cefazolin 3gm in DUPLEX (50ml)
Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing >/= 120 kg
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin 3gm Injection | Experimental | Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min). Receives: Drug: Cefazolin 3gm for Injection USP and Dextrose Injection USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cefazolin Plasma Concentration Following Infusion
Concentrations will be determined through analysis of 5 blood samples drawn at 0.5 (end of infusion), 1, 2, 4, and 8 hours after the start of study drug infusion.
Measured: 8 hours
Secondary outcomes (39)
Number of Participants With Treatment-Emergent Adverse Events [Safety] According to Study Protocol
Safety will be assessed by monitoring adverse events (AEs), physical examination, vital signs, and clinical laboratory tests.
Measured: 2 days with optional visit on Day 8
Hematology: Hemoglobin (Hb)
gm/L
Measured: 2 days with optional visit on Day 8
Hematology: Hematocrit (Hct)
Measured: 2 days with optional visit on Day 8
Hematology: Mean Corpuscular Volume (MCV)
fL
Measured: 2 days with optional visit on Day 8
Hematology: Mean Corpuscular Hemoglobin (MCH)
pg
Measured: 2 days with optional visit on Day 8
Hematology: Mean Corpuscular Hemoglobin Concentration
mmol/L
Measured: 2 days with optional visit on Day 8
Hematology: Platelet Count
platelets / L
Measured: 2 days with optional visit on Day 8
Hematology: RBC
cells/L
Measured: 2 days with optional visit on Day 8
Hematology: WBC
cells/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Sodium
mmol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Potassium
mmol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Chloride
mmol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: CO2 (Bicarbonate)
mmol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Glucose
mmol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: ALT
IU/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: AST
IU/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Creatine Phosphokinase (CPK)
ukat / L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Lactic Acid Dehydrogenase (LDH)
IU/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Albumin
g/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Alkaline Phosphatase
IU/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Uric Acid
umol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Calcium
mmol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Phosphate
mmol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Total Protein
g/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Total Bilirubin
micro-mol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Blood Urea Nitrogen
mmol/L
Measured: 2 days with optional visit on Day 8
Clinical Chemistry: Creatinine
micro-mol/L
Measured: 2 days with optional visit on Day 8
Vital Signs: Temperature
Degree centigrade
Measured: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Vital Signs: Blood Pressure (Systolic)
mm Hg
Measured: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Vital Signs: Heart Rate
Beats per minute
Measured: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Vital Signs: Respiratory Rate
Breaths per minute
Measured: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Vital Signs: Weight
kg
Measured: Baseline
Vital Signs: Height
cm
Measured: Baseline
Vital Signs: BMI
kg/cm^2
Measured: Baseline
ECG: PR Interval
msec
Measured: 2 days
ECG: QRS Duration
msec
Measured: 2 days
ECG: QT Interval
msec
Measured: 2 days
Urine Pregnancy Test
(If appropriate) If positive, a confirmatory serum test will be performed.
Measured: Baseline
Vital Signs: Blood Pressure (Diastolic)
mm Hg
Measured: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start5 Apr 2022
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
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 (11)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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, non-randomized pharmacokinetic study. All subjects will be receiving the same study treatment, thus blinding is unnecessary.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205486
- Sponsor's protocol ID
- US-G-H-2101
- Acronym
- 3gCefPK
- Status last verified
- Feb 2025
- First submitted
- 11 Oct 2021
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haessler D, Reverdy ME, Neidecker J, Brule P, Ninet J, Lehot JJ. Antibiotic prophylaxis with cefazolin and gentamicin in cardiac surgery for children less than ten kilograms. J Cardiothorac Vasc Anesth. 2003 Apr;17(2):221-5. doi: 10.1053/jcan.2003.51.
PubMed 12698406Kamath VH, Cheung JP, Mak KC, Wong YW, Cheung WY, Luk KD, Cheung KM. Antimicrobial prophylaxis to prevent surgical site infection in adolescent idiopathic scoliosis patients undergoing posterior spinal fusion: 2 doses versus antibiotics till drain removal. Eur Spine J. 2016 Oct;25(10):3242-3248. doi: 10.1007/s00586-016-4491-7. Epub 2016 Mar 12.
PubMed 26971263Khan AJ. Clinical and laboratory evaluation of cefazolin: a new cephalosporin antibiotic in pediatric patients. Curr Ther Res Clin Exp. 1973 Oct;15(10):727-33. No abstract available.
PubMed 4201317Koshida R, Nakashima E, Ichimura F, Nakano O, Watanabe R, Taniguchi N, Tsuji A. Comparative distribution kinetics of cefazolin and tobramycin in children. J Pharmacobiodyn. 1987 Sep;10(9):436-42. doi: 10.1248/bpb1978.10.436.
PubMed 3437384Lee KR, Ring JC, Leggiadro RJ. Prophylactic antibiotic use in pediatric cardiovascular surgery: a survey of current practice. Pediatr Infect Dis J. 1995 Apr;14(4):267-9. doi: 10.1097/00006454-199504000-00004.
PubMed 7603806Leggett JE, Fantin B, Ebert S, Totsuka K, Vogelman B, Calame W, Mattie H, Craig WA. Comparative antibiotic dose-effect relations at several dosing intervals in murine pneumonitis and thigh-infection models. J Infect Dis. 1989 Feb;159(2):281-92. doi: 10.1093/infdis/159.2.281.
PubMed 2644371Maher KO, VanDerElzen K, Bove EL, Mosca RS, Chenoweth CE, Kulik TJ. A retrospective review of three antibiotic prophylaxis regimens for pediatric cardiac surgical patients. Ann Thorac Surg. 2002 Oct;74(4):1195-200. doi: 10.1016/s0003-4975(02)03893-6.
PubMed 12400768Rodgers GL, Fisher MC, Lo A, Cresswell A, Long SS. Study of antibiotic prophylaxis during burn wound debridement in children. J Burn Care Rehabil. 1997 Jul-Aug;18(4):342-6. doi: 10.1097/00004630-199707000-00012.
PubMed 9261702Ross S, Rodriguez W, Khan W. The cephalosporin antibiotics in pediatric practice. South Med J. 1977 Jul;70(7):855-61. doi: 10.1097/00007611-197707000-00026.
PubMed 877649Schmitz 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 25941220Schmitz ML, Rubino CM, Onufrak NJ, Martinez DV, Licursi D, Karpf A, Cetnarowski W. Pharmacokinetics and Optimal Dose Selection of Cefazolin for Surgical Prophylaxis of Pediatric Patients. J Clin Pharmacol. 2021 May;61(5):666-676. doi: 10.1002/jcph.1785. Epub 2020 Dec 9.
PubMed 33202066
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of a Single 3 Gram Dose of Cefazolin in Adult Subjects Weighing >= 120 kg Scheduled for Surgery
- ClinicalTrials.gov ID
- NCT05205486
- Acronym / sponsor ID
- 3gCefPK / US-G-H-2101
- Conditions
- Infections
- Keywords
- Cephalosporin, antibiotic, infection control, surgical prophylaxis
- 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
- 5 Apr 2022 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the pharmacokinetics (PK) of a single 3 gm dose of cefazolin from a DUPLEX container, in adult subjects (weighing >/= 120 kg) scheduled for surgery. Cefazolin will be administered as a 30-minute intravenous (IV) infusion, per cefazolin Package Insert. Five PK samples per subject will be obtained up to 8 hours after dosing. These data will then be assessed by the validated Cefazolin PK Model to verify there are no significant PK changes within this study population.
Detailed description
This is a Phase 1, open-label, single-dose, multiple-center, study to determine the pharmacokinetics of a single 3 g dose of cefazolin administered as a 30 minute IV infusion prior to surgery in adult subjects weighing >/= 120 kg. Adult subjects will be enrolled in order to ensure at least 12 subjects complete the study. Enrollment will be competitive across the study sites. All subjects will have Screening and baseline evaluations performed to ensure their eligibility for the study The Screening Period is up to 30 days before administration of study drug on Day 1.
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). Planned surgical procedures may be performed outpatient or inpatient and are expected to last no longer than 3 hours.
If the surgery is extended unexpectedly beyond the 3-hour limit, additional doses of study drug are permitted according to institutional guidelines. PK blood sample collection will continue after the administration of an additional dose of cefazolin. Safety in this population will also be assessed.
All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min) and 8 h (+/-15 min).
Safety will be assessed by monitoring adverse events (AEs), physical examination, vital signs, and clinical laboratory tests. A follow-up visit will be performed on Day 8 (+/-1 day) for safety assessments.
A subject is considered a study completer if he/she has completed all study related procedures through the end of surgery and the required PK sample collections. It is highly preferred that the subjects also participate in the Day 8 (+/-1 day) Safety Follow-up. For subjects who withdraw or are withdrawn before study completion of the study, every effort will be made to perform all Safety Follow up procedures.
Any subject who withdraws or is withdrawn before collection of at least 4 of the 5 PK samples will not be consider as a PK completer. If necessary, additional subjects must be enrolled to ensure that there are at least 12 PK completers.
On Day 8 (+/-1 day), a Safety follow-up will be conducted. If this is an in-person visit, the following will be performed: vital signs, clinical laboratory tests, examination of the infusion site, review of AEs and concomitant medication. If an in-person visit is not possible, every effort will be made to contact the subject by phone and the subjects will be asked about any AEs and concomitant medication they may have taken.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, non-randomized pharmacokinetic study. All subjects will be receiving the same study treatment, thus blinding is unnecessary.
| Arm | Type | Receives |
|---|---|---|
| Cefazolin 3gm Injection | Experimental | Drug: Cefazolin 3gm for Injection USP and Dextrose Injection USPStudy drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged >/= 18 years;
- Must weigh >/= 120 kg
- Able to understand and sign the Informed Consent Form(s) (ICF);
- Is scheduled for surgery that is expected to last less than 3 hours;
- Is scheduled for any type of surgery where a single-dose perioperative cefazolin prophylaxis is appropriate.
Key exclusion criteria (17 listed)
- If female, is pregnant or lactating/breastfeeding.
- If female that is of childbearing potential and sexually active, and is not using an effective method of birth control, e.g., oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or have a partner with a vasectomy.
- Has a history of renal impairment -- Subject has an eGFR of <80 mL/min/1.73m2 performed at Screening as calculated by the following equation: 186 x (Creatinine/88.4)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if black) (FDA Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function)
- Has a known allergy or hypersensitivity to β lactam/cephalosporin antibiotics, corn products, or dextrose-containing products or solutions, or any of the other ingredients of Cefazolin for Injection United States Pharmacopeia (USP) and Dextrose Injection USP in DUPLEX.
- Has a result of any laboratory test (or repeat test, if done), obtained as standard of care, that is outside the normal limit of the site's laboratory reference range AND is considered by the investigator to be clinically significant.
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 3gm for Injection USP and Dextrose Injection USPAlso: Cefazolin 3gm in DUPLEX (50ml)Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing >/= 120 kg | Drug | Cefazolin 3gm Injection |
Primary outcome
Cefazolin Plasma Concentration Following Infusion
Time frame: 8 hours
Concentrations will be determined through analysis of 5 blood samples drawn at 0.5 (end of infusion), 1, 2, 4, and 8 hours after the start of study drug infusion.
39 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events [Safety] According to Study Protocol
Time frame: 2 days with optional visit on Day 8
Hematology: Hemoglobin (Hb)
Time frame: 2 days with optional visit on Day 8
Hematology: Hematocrit (Hct)
Time frame: 2 days with optional visit on Day 8
Hematology: Mean Corpuscular Volume (MCV)
Time frame: 2 days with optional visit on Day 8
Hematology: Mean Corpuscular Hemoglobin (MCH)
Time frame: 2 days with optional visit on Day 8
Hematology: Mean Corpuscular Hemoglobin Concentration
Time frame: 2 days with optional visit on Day 8
Hematology: Platelet Count
Time frame: 2 days with optional visit on Day 8
Hematology: RBC
Time frame: 2 days with optional visit on Day 8
Hematology: WBC
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Sodium
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Potassium
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Chloride
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: CO2 (Bicarbonate)
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Glucose
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: ALT
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: AST
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Creatine Phosphokinase (CPK)
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Lactic Acid Dehydrogenase (LDH)
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Albumin
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Alkaline Phosphatase
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Uric Acid
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Calcium
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Phosphate
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Total Protein
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Total Bilirubin
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Blood Urea Nitrogen
Time frame: 2 days with optional visit on Day 8
Clinical Chemistry: Creatinine
Time frame: 2 days with optional visit on Day 8
Vital Signs: Temperature
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Vital Signs: Blood Pressure (Systolic)
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Vital Signs: Heart Rate
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Vital Signs: Respiratory Rate
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Vital Signs: Weight
Time frame: Baseline
Vital Signs: Height
Time frame: Baseline
Vital Signs: BMI
Time frame: Baseline
ECG: PR Interval
Time frame: 2 days
ECG: QRS Duration
Time frame: 2 days
ECG: QT Interval
Time frame: 2 days
Urine Pregnancy Test
Time frame: Baseline
Vital Signs: Blood Pressure (Diastolic)
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12698406Haessler D, Reverdy ME, Neidecker J, Brule P, Ninet J, Lehot JJ. Antibiotic prophylaxis with cefazolin and gentamicin in cardiac surgery for children less than ten kilograms. J Cardiothorac Vasc Anesth. 2003 Apr;17(2):221-5. doi: 10.1053/jcan.2003.51.
- Background: PubMed 26971263Kamath VH, Cheung JP, Mak KC, Wong YW, Cheung WY, Luk KD, Cheung KM. Antimicrobial prophylaxis to prevent surgical site infection in adolescent idiopathic scoliosis patients undergoing posterior spinal fusion: 2 doses versus antibiotics till drain removal. Eur Spine J. 2016 Oct;25(10):3242-3248. doi: 10.1007/s00586-016-4491-7. Epub 2016 Mar 12.
- Background: PubMed 4201317Khan AJ. Clinical and laboratory evaluation of cefazolin: a new cephalosporin antibiotic in pediatric patients. Curr Ther Res Clin Exp. 1973 Oct;15(10):727-33. No abstract available.
- Background: PubMed 3437384Koshida R, Nakashima E, Ichimura F, Nakano O, Watanabe R, Taniguchi N, Tsuji A. Comparative distribution kinetics of cefazolin and tobramycin in children. J Pharmacobiodyn. 1987 Sep;10(9):436-42. doi: 10.1248/bpb1978.10.436.
- Background: PubMed 7603806Lee KR, Ring JC, Leggiadro RJ. Prophylactic antibiotic use in pediatric cardiovascular surgery: a survey of current practice. Pediatr Infect Dis J. 1995 Apr;14(4):267-9. doi: 10.1097/00006454-199504000-00004.
- Background: PubMed 2644371Leggett JE, Fantin B, Ebert S, Totsuka K, Vogelman B, Calame W, Mattie H, Craig WA. Comparative antibiotic dose-effect relations at several dosing intervals in murine pneumonitis and thigh-infection models. J Infect Dis. 1989 Feb;159(2):281-92. doi: 10.1093/infdis/159.2.281.
- Background: PubMed 12400768Maher KO, VanDerElzen K, Bove EL, Mosca RS, Chenoweth CE, Kulik TJ. A retrospective review of three antibiotic prophylaxis regimens for pediatric cardiac surgical patients. Ann Thorac Surg. 2002 Oct;74(4):1195-200. doi: 10.1016/s0003-4975(02)03893-6.
- Background: PubMed 9261702Rodgers GL, Fisher MC, Lo A, Cresswell A, Long SS. Study of antibiotic prophylaxis during burn wound debridement in children. J Burn Care Rehabil. 1997 Jul-Aug;18(4):342-6. doi: 10.1097/00004630-199707000-00012.
- Background: PubMed 877649Ross S, Rodriguez W, Khan W. The cephalosporin antibiotics in pediatric practice. South Med J. 1977 Jul;70(7):855-61. doi: 10.1097/00007611-197707000-00026.
- Background: 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.
- Background: PubMed 33202066Schmitz ML, Rubino CM, Onufrak NJ, Martinez DV, Licursi D, Karpf A, Cetnarowski W. Pharmacokinetics and Optimal Dose Selection of Cefazolin for Surgical Prophylaxis of Pediatric Patients. J Clin Pharmacol. 2021 May;61(5):666-676. doi: 10.1002/jcph.1785. Epub 2020 Dec 9.
- Nahata MC, Winters CB, Powell DA. Variation in prophylactic antibiotic use in pediatric orthopedic surgery. Drug Intell Clin Pharm. 1985;19(11):834-6Link provided by the sponsor.
- Nahata MC, Durrell DE, Ginn-Pease ME, et al. Pharmacokinetics and tissue concentrations of cefazolin in pediatric patients undergoing gastrointestinal surgery. Eur J Drug Metab Pharmacokinet. 1991;16(1):49-52Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 3gm for Injection USP and Dextrose Injection USP 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 5 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 28 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2025). 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?
Cefazolin Plasma Concentration Following Infusion (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 NCT05205486, which also lists 11 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 28 Feb 2025.