Trial Outcomes & Findings for Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects (NCT NCT03231228)
NCT ID: NCT03231228
Last Updated: 2020-07-13
Results Overview
Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
8 days
Results posted on
2020-07-13
Participant Flow
Participant milestones
| Measure |
Cefazolin 1 g Infusion
Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg
|
Cefazolin 2 g Infusion
Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
28
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Cefazolin 1 g Infusion
Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg
|
Cefazolin 2 g Infusion
Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects
Baseline characteristics by cohort
| Measure |
Cefazolin 1 g Infusion
n=33 Participants
Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg
|
Cefazolin 2 g Infusion
n=28 Participants
Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
28 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Weight
|
49.68 kg
n=5 Participants
|
81.49 kg
n=7 Participants
|
64.29 kg
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 daysSafety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.
Outcome measures
| Measure |
Cefazolin 1 g Infusion
n=33 Participants
Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg
|
Cefazolin 2 g Infusion
n=28 Participants
Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety]
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 4 hours after start of study drug infusionConcentrations will be determined through analysis of 4 blood samples drawn at 0.5-1, 2, 3, and 4 hours after the start of study drug infusion.
Outcome measures
| Measure |
Cefazolin 1 g Infusion
n=12 Participants
Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg
|
Cefazolin 2 g Infusion
n=11 Participants
Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
|
|---|---|---|
|
Cefazolin Plasma Concentration Following Infusion
0.5 - 1.0 HR
|
124.7 mcg/mL
Standard Deviation 33.880
|
145.5 mcg/mL
Standard Deviation 62.116
|
|
Cefazolin Plasma Concentration Following Infusion
2 HR
|
53.51 mcg/mL
Standard Deviation 14.399
|
93.26 mcg/mL
Standard Deviation 42.267
|
|
Cefazolin Plasma Concentration Following Infusion
3 HR
|
37.35 mcg/mL
Standard Deviation 10.273
|
57.74 mcg/mL
Standard Deviation 24.106
|
|
Cefazolin Plasma Concentration Following Infusion
4 HR
|
27.30 mcg/mL
Standard Deviation 6.0245
|
45.03 mcg/mL
Standard Deviation 20.232
|
Adverse Events
Cefazolin 1 g Infusion
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Cefazolin 2 g Infusion
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cefazolin 1 g Infusion
n=33 participants at risk
Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg
|
Cefazolin 2 g Infusion
n=28 participants at risk
Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post-Operative Pain
|
3.0%
1/33 • Number of events 1 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
Other adverse events
| Measure |
Cefazolin 1 g Infusion
n=33 participants at risk
Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg
|
Cefazolin 2 g Infusion
n=28 participants at risk
Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.1%
3/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
21.4%
6/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
General disorders
Chills
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
General disorders
Infusion site pain
|
6.1%
2/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
7.1%
2/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
General disorders
Infusion site erythema
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
7.1%
2/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
General disorders
Infusion site warmth
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
General disorders
Catheter site bruise
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
General disorders
Infusion site bruising
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
General disorders
Injection site bruising
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
General disorders
Pyrexia
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Nervous system disorders
Headache
|
9.1%
3/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Nervous system disorders
Migraine
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
7.1%
2/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.1%
2/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Injury, poisoning and procedural complications
Anaesthetic complication neurological
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
6.1%
2/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Eye disorders
Conjunctival hyperaemia
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Eye disorders
Eye pain
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
1/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
0.00%
0/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Vascular disorders
Hot flush
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
|
Vascular disorders
Hypotension
|
0.00%
0/33 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
3.6%
1/28 • 39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the PI may publish data or results from the Study; provided that the PI submits the proposed publication to Sponsor for review at least sixty (60) days prior to the date of submission to the proposed publication. Sponsor may request that any Confidential Information be removed from the proposed publication other than Study data and results. The Investigator certifies that it shall not publish any Study related material other than per this agreement.
- Publication restrictions are in place
Restriction type: OTHER