Infectious DiseaseNCT05388747
Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates
An observational study of Infectious Disease, run by Shandong University at 1 site in China.
Trial summary
Cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. However, population pharmacokinetic，effectiveness and safety data for cefuroxime in neonates are lacking. The aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Cefuroxime
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2022to 1 Dec 2025
- Phase
- Observational
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: neonatal patients with infections
Who may be able to join
- Age: postnatal age ≤28 days;
- Cefuroxime used as part of antimicrobial treatment;
- Parental written consent.
Who cannot join
- Expected survival time less than the treatment cycle;
- Receiving other systemic trial drug therapy;
- Other factors that the researcher considers unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, 30000
Xiuying Tian, bachelor, 022-58287230, txyjk2008@163.com
Xiuying Tian, bachelor
About this study
Cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. However, population pharmacokinetic，effectiveness and safety data for cefuroxime in neonates are lacking. The aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates.
- Conditions
- Infectious Disease
- Being tested
- Cefuroxime
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefuroximeDrug
Population pharmacokinetics, effectiveness, and safety of cefuroxime
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak plasma drug concentration of cefuroxime
To detect the peak plasma drug concentration of cefuroxime after intravenous administration.
Measured: at (5-10) minutes after intravenous administration
The random plasma drug concentration of cefuroxime
To detect the random plasma drug concentration of cefuroxime after intravenous administration.
Measured: at (0.25-10) hours after intravenous administration.
The trough plasma drug concentration of cefuroxime
To detect the trough plasma drug concentration of cefuroxime after intravenous administration.
Measured: at 1-2 hours before the next administration
The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC)
PD target
Measured: Through study completion, an average of 3 days
Adverse events
Drug-related adverse events and serious adverse events
Measured: Through study completion, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start16 May 2022 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Central Hospital of Gynecology Obstetrics
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388747
- Sponsor's protocol ID
- 2022-PPK-002
- Status last verified
- May 2022
- First submitted
- 22 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates
- ClinicalTrials.gov ID
- NCT05388747
- Acronym / sponsor ID
- 2022-PPK-002
- Conditions
- Infectious Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Tianjin Central Hospital of Gynecology Obstetrics
- Study start
- 16 May 2022 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 May 2022 (actual)
- 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.
Cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. However, population pharmacokinetic，effectiveness and safety data for cefuroxime in neonates are lacking. The aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- neonatal patients with infections
Key inclusion criteria (3 listed)
- Age: postnatal age ≤28 days;
- Cefuroxime used as part of antimicrobial treatment;
- Parental written consent.
Key exclusion criteria (3 listed)
- Expected survival time less than the treatment cycle;
- Receiving other systemic trial drug therapy;
- Other factors that the researcher considers unsuitable for inclusion.
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 |
|---|---|---|
| CefuroximePopulation pharmacokinetics, effectiveness, and safety of cefuroxime | Drug | – |
Primary outcome
The peak plasma drug concentration of cefuroxime
Time frame: at (5-10) minutes after intravenous administration
To detect the peak plasma drug concentration of cefuroxime after intravenous administration.
The random plasma drug concentration of cefuroxime
Time frame: at (0.25-10) hours after intravenous administration.
To detect the random plasma drug concentration of cefuroxime after intravenous administration.
The trough plasma drug concentration of cefuroxime
Time frame: at 1-2 hours before the next administration
To detect the trough plasma drug concentration of cefuroxime after intravenous administration.
The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC)
Time frame: Through study completion, an average of 3 days
PD target
Adverse events
Time frame: Through study completion, an average of 15 days
Drug-related adverse events and serious adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease, run by Shandong University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 24 May 2022. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The peak plasma drug concentration of cefuroxime (time frame: at (5-10) minutes after intravenous administration). The study lists 5 primary outcomes in all. 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 24 May 2022.