Infections
Conditions
Keywords
Cephalosporin, antibiotic, infection control, surgical prophylaxis
Brief 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. 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.
Interventions
DRUGCefazolin 3gm for Injection USP and Dextrose Injection USP
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
Sponsors
B. Braun Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label, non-randomized pharmacokinetic study. All subjects will be receiving the same study treatment, thus masking is unnecessary.
Intervention model description
This is an open-label, non-randomized pharmacokinetic study. All subjects will be receiving the same study treatment, thus blinding is unnecessary.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female aged \>/= 18 years; 2. Must weigh \>/= 120 kg 3. Able to understand and sign the Informed Consent Form(s) (ICF); 4. Is scheduled for surgery that is expected to last less than 3 hours; 5. Is scheduled for any type of surgery where a single-dose perioperative cefazolin prophylaxis is appropriate.
Exclusion criteria
1. If female, is pregnant or lactating/breastfeeding. 2. 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. 3. 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) 4. 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. 5. 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. 6. Has had a recent (within 14 days prior to the planned surgery) administration of cefazolin. 7. 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. 8. Has a known history of human immunodeficiency virus, hepatitis B, or hepatitis C infection. 9. Has a current history of medical condition(s), which in the opinion of the investigator, would interfere with the evaluation of the study treatment. 10. Has a known history of organ transplant. 11. Has a clinically relevant disease/dysfunction of or a history of severe cardiac, pulmonary or hepatic disease. 12. 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. 13. Has received any other investigational drug/device within 30 days prior to the study treatment administration. 14. Has any planned medical intervention or personal event that might interfere with ability to comply with the study requirements. 15. 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. 16. Is unable or unwilling to adhere to the study-specified procedures and restrictions. 17. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cefazolin Plasma Concentration Following Infusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematology: Hemoglobin (Hb) | 2 days with optional visit on Day 8 | gm/L |
| Hematology: Hematocrit (Hct) | 2 days with optional visit on Day 8 | — |
| Hematology: Mean Corpuscular Volume (MCV) | 2 days with optional visit on Day 8 | fL |
| Hematology: Mean Corpuscular Hemoglobin (MCH) | 2 days with optional visit on Day 8 | pg |
| Hematology: Mean Corpuscular Hemoglobin Concentration | 2 days with optional visit on Day 8 | mmol/L |
| Hematology: Platelet Count | 2 days with optional visit on Day 8 | platelets / L |
| Hematology: RBC | 2 days with optional visit on Day 8 | cells/L |
| Hematology: WBC | 2 days with optional visit on Day 8 | cells/L |
| Clinical Chemistry: Sodium | 2 days with optional visit on Day 8 | mmol/L |
| Clinical Chemistry: Potassium | 2 days with optional visit on Day 8 | mmol/L |
| Clinical Chemistry: Chloride | 2 days with optional visit on Day 8 | mmol/L |
| Clinical Chemistry: CO2 (Bicarbonate) | 2 days with optional visit on Day 8 | mmol/L |
| Clinical Chemistry: Glucose | 2 days with optional visit on Day 8 | mmol/L |
| Clinical Chemistry: ALT | 2 days with optional visit on Day 8 | IU/L |
| Clinical Chemistry: AST | 2 days with optional visit on Day 8 | IU/L |
| Clinical Chemistry: Creatine Phosphokinase (CPK) | 2 days with optional visit on Day 8 | ukat / L |
| Clinical Chemistry: Lactic Acid Dehydrogenase (LDH) | 2 days with optional visit on Day 8 | IU/L |
| Clinical Chemistry: Albumin | 2 days with optional visit on Day 8 | g/L |
| Clinical Chemistry: Alkaline Phosphatase | 2 days with optional visit on Day 8 | IU/L |
| Number of Participants With Treatment-Emergent Adverse Events [Safety] According to Study Protocol | 2 days with optional visit on Day 8 | Safety will be assessed by monitoring adverse events (AEs), physical examination, vital signs, and clinical laboratory tests. |
| Clinical Chemistry: Calcium | 2 days with optional visit on Day 8 | mmol/L |
| Clinical Chemistry: Phosphate | 2 days with optional visit on Day 8 | mmol/L |
| Clinical Chemistry: Total Protein | 2 days with optional visit on Day 8 | g/L |
| Clinical Chemistry: Total Bilirubin | 2 days with optional visit on Day 8 | micro-mol/L |
| Clinical Chemistry: Blood Urea Nitrogen | 2 days with optional visit on Day 8 | mmol/L |
| Clinical Chemistry: Creatinine | 2 days with optional visit on Day 8 | micro-mol/L |
| Vital Signs: Temperature | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery | Degree centigrade |
| Vital Signs: Blood Pressure (Systolic) | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery | mm Hg |
| Vital Signs: Heart Rate | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery | Beats per minute |
| Vital Signs: Respiratory Rate | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery | Breaths per minute |
| Vital Signs: Weight | Baseline | kg |
| Vital Signs: Height | Baseline | cm |
| Vital Signs: BMI | Baseline | kg/cm\^2 |
| ECG: PR Interval | 2 days | msec |
| ECG: QRS Duration | 2 days | msec |
| ECG: QT Interval | 2 days | msec |
| Urine Pregnancy Test | Baseline | (If appropriate) If positive, a confirmatory serum test will be performed. |
| Vital Signs: Blood Pressure (Diastolic) | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery | mm Hg |
| Clinical Chemistry: Uric Acid | 2 days with optional visit on Day 8 | umol/L |
Countries
United States
Participant flow
Pre-assignment details
There were no pre-assignment activities for this study.
Participants by arm
| Arm | Count |
|---|---|
| Cefazolin 3gm Injection 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).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: 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 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Cefazolin 3gm Injection |
|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 16.76 |
| Baseline Weight | 134.82 kg STANDARD_DEVIATION 8.133 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: 8 hours
Population: Only one (1) subject agreed to the 8-hour PK blood sample.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Cefazolin Plasma Concentration Following Infusion | 0.5 hours post infusion | 491 ug/mL | Standard Deviation 702 |
| Cefazolin 3gm Injection | Cefazolin Plasma Concentration Following Infusion | 1 hour post infusion | 117 ug/mL | Standard Deviation 25.8 |
| Cefazolin 3gm Injection | Cefazolin Plasma Concentration Following Infusion | 2 hours post infusion | 99.7 ug/mL | Standard Deviation 21.6 |
| Cefazolin 3gm Injection | Cefazolin Plasma Concentration Following Infusion | 4 hours post infusion | 57.9 ug/mL | Standard Deviation 34.4 |
| Cefazolin 3gm Injection | Cefazolin Plasma Concentration Following Infusion | 8 hours post infusion | 18.4 ug/mL | — |
Secondary
Clinical Chemistry: Albumin
g/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Albumin | Baseline | 39.8 g/L | Standard Deviation 3.71 |
| Cefazolin 3gm Injection | Clinical Chemistry: Albumin | Day 2 Discharge | 38.0 g/L | Standard Deviation 4.69 |
Secondary
Clinical Chemistry: Alkaline Phosphatase
IU/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Alkaline Phosphatase | Baseline | 83.08 IU/L | Standard Deviation 19.91 |
| Cefazolin 3gm Injection | Clinical Chemistry: Alkaline Phosphatase | Day 2 Discharge | 78.58 IU/L | Standard Deviation 37.15 |
Secondary
Clinical Chemistry: ALT
IU/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: ALT | Baseline | 21.1 IU / L | Standard Deviation 8.35 |
| Cefazolin 3gm Injection | Clinical Chemistry: ALT | Day 2 Discharge | 28.2 IU / L | Standard Deviation 8.35 |
Secondary
Clinical Chemistry: AST
IU/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: AST | Baseline | 19.6 IU / L | Standard Deviation 5.81 |
| Cefazolin 3gm Injection | Clinical Chemistry: AST | Day 2 Discharge | 39.0 IU / L | Standard Deviation 30.25 |
Secondary
Clinical Chemistry: Blood Urea Nitrogen
mmol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Blood Urea Nitrogen | Baseline | 6.64 mmol/L | Standard Deviation 2.4 |
| Cefazolin 3gm Injection | Clinical Chemistry: Blood Urea Nitrogen | Day 2 Discharge | 5.63 mmol/L | Standard Deviation 1.68 |
Secondary
Clinical Chemistry: Calcium
mmol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 7 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Calcium | Baseline | 2.24 mmol/L | Standard Deviation 0.106 |
| Cefazolin 3gm Injection | Clinical Chemistry: Calcium | Day 2 Discharge | 2.11 mmol/L | Standard Deviation 0.075 |
Secondary
Clinical Chemistry: Chloride
mmol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Chloride | Day 2 Discharge | 105.5 mmol / L | Standard Deviation 5.39 |
| Cefazolin 3gm Injection | Clinical Chemistry: Chloride | Baseline | 103.3 mmol / L | Standard Deviation 3.89 |
Secondary
Clinical Chemistry: CO2 (Bicarbonate)
mmol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: CO2 (Bicarbonate) | Baseline | 22.7 mmol / L | Standard Deviation 4.1 |
| Cefazolin 3gm Injection | Clinical Chemistry: CO2 (Bicarbonate) | Day 2 Discharge | 22.5 mmol / L | Standard Deviation 6.5 |
Secondary
Clinical Chemistry: Creatine Phosphokinase (CPK)
ukat / L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 5 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Creatine Phosphokinase (CPK) | Baseline | 2.73 ukat / L | Standard Deviation 4.68 |
| Cefazolin 3gm Injection | Clinical Chemistry: Creatine Phosphokinase (CPK) | Day 2 Discharge | 3.76 ukat / L | Standard Deviation 3.4 |
Secondary
Clinical Chemistry: Creatinine
micro-mol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Creatinine | Baseline | 79.4 Umol/L | Standard Deviation 27.5 |
| Cefazolin 3gm Injection | Clinical Chemistry: Creatinine | Day 2 Discharge | 68.46 Umol/L | Standard Deviation 17.56 |
Secondary
Clinical Chemistry: Glucose
mmol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Glucose | Baseline | 6.36 mmol / L | Standard Deviation 2.91 |
| Cefazolin 3gm Injection | Clinical Chemistry: Glucose | Day 2 Discharge | 7.71 mmol / L | Standard Deviation 2.24 |
Secondary
Clinical Chemistry: Lactic Acid Dehydrogenase (LDH)
IU/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 5 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Lactic Acid Dehydrogenase (LDH) | Baseline | 238.5 IU/L | Standard Deviation 68.99 |
| Cefazolin 3gm Injection | Clinical Chemistry: Lactic Acid Dehydrogenase (LDH) | Day 2 Discharge | 216.8 IU/L | Standard Deviation 59.49 |
Secondary
Clinical Chemistry: Phosphate
mmol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Phosphate | Baseline | 1.11 mmol/L | Standard Deviation 0.29 |
| Cefazolin 3gm Injection | Clinical Chemistry: Phosphate | Day 2 Discharge | 1.10 mmol/L | Standard Deviation 0.28 |
Secondary
Clinical Chemistry: Potassium
mmol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 7 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Potassium | Day 2 Discharge | 3.99 mmol / L | Standard Deviation 0.776 |
| Cefazolin 3gm Injection | Clinical Chemistry: Potassium | Baseline | 4.32 mmol / L | Standard Deviation 0.463 |
Secondary
Clinical Chemistry: Sodium
mmol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Sodium | Baseline | 140.6 mmol / L | Standard Deviation 2.27 |
| Cefazolin 3gm Injection | Clinical Chemistry: Sodium | Day 2 Discharge | 138.8 mmol / L | Standard Deviation 1.72 |
Secondary
Clinical Chemistry: Total Bilirubin
micro-mol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Total Bilirubin | Baseline | 7.65 micro-mol/L | Standard Deviation 4.17 |
| Cefazolin 3gm Injection | Clinical Chemistry: Total Bilirubin | Day 2 Discharge | 7.30 micro-mol/L | Standard Deviation 4.7 |
Secondary
Clinical Chemistry: Total Protein
g/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Total Protein | Baseline | 66.1 g/L | Standard Deviation 3.58 |
| Cefazolin 3gm Injection | Clinical Chemistry: Total Protein | Day 2 Discharge | 67.2 g/L | Standard Deviation 2.99 |
Secondary
Clinical Chemistry: Uric Acid
umol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Clinical Chemistry: Uric Acid | Baseline | 334.7 umol/L | Standard Deviation 110.5 |
| Cefazolin 3gm Injection | Clinical Chemistry: Uric Acid | Day 2 Discharge | 316.4 umol/L | Standard Deviation 128.8 |
Secondary
ECG: PR Interval
msec
Time frame: 2 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | ECG: PR Interval | Baseline | 163.8 msec | Standard Deviation 44.08 |
| Cefazolin 3gm Injection | ECG: PR Interval | Day 2 Discharge | 154.2 msec | Standard Deviation 14.41 |
Secondary
ECG: QRS Duration
msec
Time frame: 2 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | ECG: QRS Duration | Baseline | 84.0 msec | Standard Deviation 10.12 |
| Cefazolin 3gm Injection | ECG: QRS Duration | Day 2 Discharge | 90.2 msec | Standard Deviation 9.44 |
Secondary
ECG: QT Interval
msec
Time frame: 2 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | ECG: QT Interval | Baseline | 377.1 msec | Standard Deviation 41.19 |
| Cefazolin 3gm Injection | ECG: QT Interval | Day 2 Discharge | 398.3 msec | Standard Deviation 35.52 |
Secondary
Hematology: Hematocrit (Hct)
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 5 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Hematology: Hematocrit (Hct) | Baseline | 0.4733 ratio | Standard Deviation 0.08105 |
| Cefazolin 3gm Injection | Hematology: Hematocrit (Hct) | Day 2 Discharge | 0.4066 ratio | Standard Deviation 0.06986 |
Secondary
Hematology: Hemoglobin (Hb)
gm/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 5 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Hematology: Hemoglobin (Hb) | Baseline | 138.5 gm/L | Standard Deviation 18.88 |
| Cefazolin 3gm Injection | Hematology: Hemoglobin (Hb) | Day 2 Discharge | 129.8 gm/L | Standard Deviation 8.93 |
Secondary
Hematology: Mean Corpuscular Hemoglobin Concentration
mmol/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 5 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Hematology: Mean Corpuscular Hemoglobin Concentration | Baseline | 295.1 mmol/L | Standard Deviation 26.28 |
| Cefazolin 3gm Injection | Hematology: Mean Corpuscular Hemoglobin Concentration | Day 2 Discharge | 323.2 mmol/L | Standard Deviation 29.99 |
Secondary
Hematology: Mean Corpuscular Hemoglobin (MCH)
pg
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 5 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Hematology: Mean Corpuscular Hemoglobin (MCH) | Baseline | 28.93 pg | Standard Deviation 3.085 |
| Cefazolin 3gm Injection | Hematology: Mean Corpuscular Hemoglobin (MCH) | Day 2 Discharge | 30.20 pg | Standard Deviation 0.574 |
Secondary
Hematology: Mean Corpuscular Volume (MCV)
fL
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 5 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Hematology: Mean Corpuscular Volume (MCV) | Baseline | 98.33 fL | Standard Error 10.655 |
| Cefazolin 3gm Injection | Hematology: Mean Corpuscular Volume (MCV) | Day 2 Discharge | 94.98 fL | Standard Error 9.976 |
Secondary
Hematology: Platelet Count
platelets / L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 6 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Hematology: Platelet Count | Baseline | 315.8 10^9 platelets/L | Standard Deviation 80.08 |
| Cefazolin 3gm Injection | Hematology: Platelet Count | Day 2 Discharge | 236.0 10^9 platelets/L | Standard Deviation 48.66 |
Secondary
Hematology: RBC
cells/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 5 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Hematology: RBC | Baseline | 4.811 10^12 cells / L | Standard Deviation 0.6083 |
| Cefazolin 3gm Injection | Hematology: RBC | Day 2 Discharge | 4.294 10^12 cells / L | Standard Deviation 0.2875 |
Secondary
Hematology: WBC
cells/L
Time frame: 2 days with optional visit on Day 8
Population: Medical staff only obtained clinical labs from 5 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Hematology: WBC | Baseline | 7.778 10^9 cells / L | Standard Deviation 1.6936 |
| Cefazolin 3gm Injection | Hematology: WBC | Day 2 Discharge | 11.170 10^9 cells / L | Standard Deviation 6.4876 |
Secondary
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.
Time frame: 2 days with optional visit on Day 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefazolin 3gm Injection | Number of Participants With Treatment-Emergent Adverse Events [Safety] According to Study Protocol | 0 Participants |
Secondary
Urine Pregnancy Test
(If appropriate) If positive, a confirmatory serum test will be performed.
Time frame: Baseline
Population: Pregnancy was an exclusionary criteria. All women enrolled where either post-menopausal or had a negative pregnancy test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefazolin 3gm Injection | Urine Pregnancy Test | 7 Participants |
Secondary
Vital Signs: Blood Pressure (Diastolic)
mm Hg
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Population: Medical staff only obtained BP from 2 subjects at the 8-hour post-infusion timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Diastolic) | Post-Infusion, 8-hr | 77.0 mm Hg | Standard Deviation 14.1 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Diastolic) | End of Surgery | 81.2 mm Hg | Standard Deviation 12.6 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Diastolic) | Baseline | 80.0 mm Hg | Standard Deviation 11.2 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Diastolic) | Post-Infusion, 30-min | 77.7 mm Hg | Standard Deviation 8.49 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Diastolic) | Post-Infusion, 2-hr | 76.8 mm Hg | Standard Deviation 17.6 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Diastolic) | Post-Infusion, 4-hr | 76.8 mm Hg | Standard Deviation 11.5 |
Secondary
Vital Signs: Blood Pressure (Systolic)
mm Hg
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Population: Medical staff only obtained BP from 2 subjects at the 8-hour post-infusion timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Systolic) | Baseline | 139.8 mm Hg | Standard Deviation 17.8 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Systolic) | Post-Infusion, 30-min | 127.9 mm Hg | Standard Deviation 17.3 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Systolic) | Post-Infusion, 2-hr | 128.4 mm Hg | Standard Deviation 28.2 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Systolic) | Post-Infusion, 4-hr | 133.9 mm Hg | Standard Deviation 16.1 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Systolic) | Post-Infusion, 8-hr | 137.5 mm Hg | Standard Deviation 24.8 |
| Cefazolin 3gm Injection | Vital Signs: Blood Pressure (Systolic) | End of Surgery | 139.3 mm Hg | Standard Deviation 23.4 |
Secondary
Vital Signs: BMI
kg/cm\^2
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefazolin 3gm Injection | Vital Signs: BMI | 45.13 kg/cm^2 | Standard Deviation 4.84 |
Secondary
Vital Signs: Heart Rate
Beats per minute
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Population: Medical staff only obtained temperature from 2 subjects at the 8-hour post-infusion timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Vital Signs: Heart Rate | Baseline | 79.8 beats per minute | Standard Deviation 17.1 |
| Cefazolin 3gm Injection | Vital Signs: Heart Rate | Post-Infusion, 30-min | 76.2 beats per minute | Standard Deviation 14.2 |
| Cefazolin 3gm Injection | Vital Signs: Heart Rate | Post-Infusion, 2-hr | 79.8 beats per minute | Standard Deviation 15.3 |
| Cefazolin 3gm Injection | Vital Signs: Heart Rate | Post-Infusion, 4-hr | 77.9 beats per minute | Standard Deviation 11.6 |
| Cefazolin 3gm Injection | Vital Signs: Heart Rate | Post-Infusion, 8-hr | 80.5 beats per minute | Standard Deviation 24.8 |
| Cefazolin 3gm Injection | Vital Signs: Heart Rate | End of Surgery | 78.8 beats per minute | Standard Deviation 12.6 |
Secondary
Vital Signs: Height
cm
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefazolin 3gm Injection | Vital Signs: Height | 173.4 cm | Standard Deviation 9.62 |
Secondary
Vital Signs: Respiratory Rate
Breaths per minute
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Population: Medical staff only obtained temperature from 2 subjects at the 8-hour post-infusion timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Vital Signs: Respiratory Rate | Baseline | 17.2 Breaths per minute | Standard Deviation 2.12 |
| Cefazolin 3gm Injection | Vital Signs: Respiratory Rate | Post-Infusion, 30-min | 16.2 Breaths per minute | Standard Deviation 2.69 |
| Cefazolin 3gm Injection | Vital Signs: Respiratory Rate | Post-Infusion, 2-hr | 16.8 Breaths per minute | Standard Deviation 4.2 |
| Cefazolin 3gm Injection | Vital Signs: Respiratory Rate | Post-Infusion, 4-hr | 16.2 Breaths per minute | Standard Deviation 1.47 |
| Cefazolin 3gm Injection | Vital Signs: Respiratory Rate | Post-Infusion, 8-hr | 17.0 Breaths per minute | Standard Deviation 1.41 |
| Cefazolin 3gm Injection | Vital Signs: Respiratory Rate | End of Surgery | 16.5 Breaths per minute | Standard Deviation 4.12 |
Secondary
Vital Signs: Temperature
Degree centigrade
Time frame: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery
Population: Medical staff only obtained temperature from 2 subjects at the 8-hour post-infusion timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cefazolin 3gm Injection | Vital Signs: Temperature | Baseline | 36.5 degrees centrigrade | Standard Deviation 0.41 |
| Cefazolin 3gm Injection | Vital Signs: Temperature | Post-Infusion, 30-min | 36.6 degrees centrigrade | Standard Deviation 0.32 |
| Cefazolin 3gm Injection | Vital Signs: Temperature | Post-Infusion, 2-hr | 36.6 degrees centrigrade | Standard Deviation 0.31 |
| Cefazolin 3gm Injection | Vital Signs: Temperature | Post-Infusion, 4-hr | 36.5 degrees centrigrade | Standard Deviation 0.2 |
| Cefazolin 3gm Injection | Vital Signs: Temperature | Post-Infusion, 8-hr | 36.8 degrees centrigrade | Standard Deviation 0.23 |
| Cefazolin 3gm Injection | Vital Signs: Temperature | End of Surgery | 36.4 degrees centrigrade | Standard Deviation 0.28 |
Secondary
Vital Signs: Weight
kg
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefazolin 3gm Injection | Vital Signs: Weight | 134.8 kg | Standard Deviation 8.13 |