SepsisPhase 1NCT00850122
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
A Phase 1 study testing cefazolin in people with Sepsis and Prematurity, run by Phillip Brian Smith at 1 site in Brazil.
Trial summary
This is a phase I open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected sepsis. There will be two cohorts of 6 infants each: 1) >48 hours of age and ≤28 days and 2) >28 days of age and <121 days of age. Read more about this study
- Who is it for?
- Ages 48 hours to 120 days
- Conditions the study is for
- Sepsis, Prematurity
- What is being tested?
- cefazolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 hours to 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- < 28 weeks gestation at birth
- > 48 hours and <121 days of age at the time of study drug administration
- One of the following:
- Suspected systemic infection
- Receiving cefazolin for prophylaxis
- Receiving cefazolin treatment of a systemic infection
Who cannot join
- History of anaphylaxis attributed to a β-lactam
- Exposure to cefazolin in the month prior to study
- Serum creatinine > 1.7 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
This is a phase I open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected sepsis. There will be two cohorts of 6 infants each: 1) >48 hours of age and ≤28 days and 2) >28 days of age and <121 days of age. The study requires administration of the study drug over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained over the 2 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.
- Conditions
- Sepsis, Prematurity
- Being tested
- cefazolin
- Medical subject headings
- Sepsis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefazolinDrug
Cefazolin dosing - administered for 48 hours Dosage
≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Experimental | Dosage Number of Infants
≤28 days of age 25 mg/kg IV q12 6 29-120 days of age 25 mg/kg IV q8 6 Receives: Drug: cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cefazolin pharmacokinetics including half life, clearance, and volume of distribution
Measured: Dose 1 and Dose 4
Secondary outcomes (1)
Safety
Measured: 7 days following last dose of cefazolin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startJul 2013
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phillip Brian Smith
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Phillip Brian Smith, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850122
- Sponsor's protocol ID
- Pro00012011
- Other IDs
- 1K23HD060040-01
- Status last verified
- Aug 2018
- First submitted
- 22 Jan 2009
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
- ClinicalTrials.gov ID
- NCT00850122
- Acronym / sponsor ID
- Pro00012011
- Conditions
- Sepsis, Prematurity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Phillip Brian SmithUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2013
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected sepsis. There will be two cohorts of 6 infants each: 1) >48 hours of age and ≤28 days and 2) >28 days of age and <121 days of age. The study requires administration of the study drug over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained over the 2 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Experimental | Drug: cefazolinDosage Number of Infants ≤28 days of age 25 mg/kg IV q12 6 29-120 days of age 25 mg/kg IV q8 6 |
Who may qualify
- Ages
- 48 hours to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- < 28 weeks gestation at birth
- > 48 hours and <121 days of age at the time of study drug administration
- One of the following:
Key exclusion criteria (3 listed)
- History of anaphylaxis attributed to a β-lactam
- Exposure to cefazolin in the month prior to study
- Serum creatinine > 1.7 mg/dL
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 |
|---|---|---|
| cefazolinCefazolin dosing - administered for 48 hours Dosage ≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8 | Drug | Cefazolin |
Primary outcome
Cefazolin pharmacokinetics including half life, clearance, and volume of distribution
Time frame: Dose 1 and Dose 4
1 secondary outcome
Safety
Time frame: 7 days following last dose of cefazolin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
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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.
1 site 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 in people with Sepsis and Prematurity, run by Phillip Brian Smith at 1 site in Brazil.
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 6 inclusion and 3 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 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cefazolin pharmacokinetics including half life, clearance, and volume of distribution (time frame: Dose 1 and Dose 4). 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 4 Sep 2018.