Postoperative InfectionPhase 4NCT03231228
Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects
A Phase 4 study testing Cefazolin 1 g Infusion and Cefazolin 2 g Infusion in people with Postoperative Infection, run by B. Braun Medical Inc. at 5 sites in United States.
Trial summary
This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Postoperative Infection
- What is being tested?
- Cefazolin 1 g Infusion and Cefazolin 2 g Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Nov 2017to 31 Jul 2019
- Phase
- Phase 4
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject is between the ages of 10 and 17 years (inclusive) at the time of giving informed consent.
- The subject is scheduled for surgery that will last less than 3 hours.
- The subject and the subject's legally authorized representative voluntarily agree that the subject will participate in this study. In accordance with applicable laws, regulations, and institutional review board requirements, the subject signs or orally agrees to an age-appropriate assent and the subject's legally authorized representative signs both an institutional review board approved informed consent form and Health Insurance Portability and Accountability Act authorization prior to the performance of any screening procedures.
- For subjects who agree to participate in the PK subgroup additional consent will be obtained.
- The subject weighs (on Day 1) ≥25 kg but <60 kg for inclusion in 1 g dose group.
- The subject weighs (on Day 1) ≥60 kg for inclusion in 2 g dose group.
- The subject has been scheduled for any type of surgery requiring single dose perioperative cefazolin prophylaxis.
Who cannot join
- Female subjects who are pregnant or lactating/breastfeeding.
- Female subjects of childbearing potential who are sexually active and who are not willing to use an effective method of birth control during the study period, eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or have a partner with a vasectomy.
- The subject has impaired renal function based on the revised Schwartz formula.
- The subject has a known allergy or hypersensitivity to β lactam/cephalosporin antibiotics, penicillins, 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.
- The subject has abnormal vital signs or an abnormal electrocardiograph (ECG) considered by the investigator to be clinically significant.
- The subject 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.
Show all 10Show fewer
- The subject has a known history of human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- The subject has a history of alcohol or drug abuse.
- The subject has received any other investigational drug/device within 30 days prior to the study drug administration.
- The subject has a history of or is currently smoking or using nicotine-containing substances or electronic cigarettes as determined by medical history or subject's verbal report.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Missouri Health Care System
Columbia, Missouri, 65212
Children's Medical Center Dallas
Dallas, Texas, 75235
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
Carilion Clinic
Roanoke, Virginia, 24013
About this study
Official title: Phase 4, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Safety of 1 g of Cefazolin in Pediatric Subjects Weighing 25 to Less Than 60 kg and 2 g of Cefazolin in Pediatric Subjects Weighing at Least 60 kg Scheduled for Surgery
This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery.
Read the detailed description
Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1 ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60 kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or gender. Additional subjects may be enrolled if necessary to ensure at least 50 evaluable subjects with complete safety data per dose group complete the study.
In a subset of approximately 40 subjects, 4 PK samples will be obtained to determine the cefazolin plasma concentrations in this population.
- Conditions
- Postoperative Infection
- Being tested
- Cefazolin 1 g Infusion, Cefazolin 2 g Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin 1 g InfusionDrug
1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to <60 kg
Cefazolin 2 g InfusionDrug
2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin 1 g Infusion | Active comparator | Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin. Receives: Drug: Cefazolin 1 g Infusion |
| Cefazolin 2 g Infusion | Active comparator | Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin. Receives: Drug: Cefazolin 2 g Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events [Safety]
Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.
Measured: 8 days
Secondary outcomes (1)
Cefazolin Plasma Concentration Following Infusion
Concentrations 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.
Measured: Up to 4 hours after start of study drug infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start20 Nov 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Why it stopped: Stopped with agreement from FDA.
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.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1 ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60 kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or gender.
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT03231228
- Sponsor's protocol ID
- HC-G-H-1601
- Status last verified
- Jun 2020
- First submitted
- 25 Jul 2017
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Safety of 1 g of Cefazolin in Pediatric Subjects Weighing 25 to Less Than 60 kg and 2 g of Cefazolin in Pediatric Subjects Weighing at Least 60 kg Scheduled for Surgery
- ClinicalTrials.gov ID
- NCT03231228
- Acronym / sponsor ID
- HC-G-H-1601
- Conditions
- Postoperative Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped with agreement from FDA.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- B. Braun Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Posted 13 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery.
Detailed description
Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1 ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60 kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or gender. Additional subjects may be enrolled if necessary to ensure at least 50 evaluable subjects with complete safety data per dose group complete the study.
In a subset of approximately 40 subjects, 4 PK samples will be obtained to determine the cefazolin plasma concentrations in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1 ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60 kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or gender.
| Arm | Type | Receives |
|---|---|---|
| Cefazolin 1 g Infusion | Active comparator | Drug: Cefazolin 1 g InfusionPediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin. |
| Cefazolin 2 g Infusion | Active comparator | Drug: Cefazolin 2 g InfusionPediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The subject is between the ages of 10 and 17 years (inclusive) at the time of giving informed consent.
- The subject is scheduled for surgery that will last less than 3 hours.
- The subject and the subject's legally authorized representative voluntarily agree that the subject will participate in this study. In accordance with applicable laws, regulations, and institutional review board requirements, the subject signs or orally agrees to an age-appropriate assent and the subject's legally authorized representative signs both an institutional review board approved informed consent form and Health Insurance Portability and Accountability Act authorization prior to the performance of any screening procedures.
- For subjects who agree to participate in the PK subgroup additional consent will be obtained.
- The subject weighs (on Day 1) ≥25 kg but <60 kg for inclusion in 1 g dose group.
Key exclusion criteria (10 listed)
- Female subjects who are pregnant or lactating/breastfeeding.
- Female subjects of childbearing potential who are sexually active and who are not willing to use an effective method of birth control during the study period, eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or have a partner with a vasectomy.
- The subject has impaired renal function based on the revised Schwartz formula.
- The subject has a known allergy or hypersensitivity to β lactam/cephalosporin antibiotics, penicillins, 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.
- The subject has abnormal vital signs or an abnormal electrocardiograph (ECG) 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 1 g Infusion1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to <60 kg | Drug | Cefazolin 1 g Infusion |
| Cefazolin 2 g Infusion2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg | Drug | Cefazolin 2 g Infusion |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events [Safety]
Time frame: 8 days
Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.
1 secondary outcome
Cefazolin Plasma Concentration Following Infusion
Time frame: Up to 4 hours after start of study drug infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Ancef (cefazolin for injection) \[package insert\]. GlaxoSmithKline. Research Triangle Park (NC); 2004 \[cited 2016 Jun 08\]Link provided by the sponsor.
- Cefazolin and Dextrose for Injection \[package insert\]. B. Braun Medical Inc. Bethlehem \[PA\]; revised 10/2015Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Postoperative Infection
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
RecruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin 1 g Infusion and Cefazolin 2 g Infusion in people with Postoperative Infection, run by B. Braun Medical Inc. at 5 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 13 Mar 2020). 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?
Number of Participants With Treatment-Emergent Adverse Events [Safety] (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2020.