Bacterial MeningitisNCT04771884
Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance
An observational study of Bacterial Meningitis and Augmented Renal Clearance, run by Shandong University at 1 site in China.
Trial summary
The investigator's purpose is to study the population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Bacterial Meningitis, Augmented Renal Clearance
- What is being tested?
- meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 20 Mar 2026
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (2 months-18 years) of bacterial meningitis with augmented renal clearance
Who may be able to join
- Children have been diagnosed with bacterial meningitis with augmented renal clearance (eGFR ≥ 160 mL/(min*1.73m2));
- Age: 2 months-18 years;
- Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and/ or linezolid used as part of regular treatment;
- Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid was administered intravenously.
Who cannot join
- Patients who die within the treatment cycle;
- Severe congenital malformation;
- Receive other systemic experimental drug therapy;
- Other factors that the researchers consider unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Wei Zhao, Phd, 86053188383308, zhao4wei2@hotmail.com
About this study
The investigator's purpose is to study the population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility.
Read the detailed description
The investigator's purpose is to study the population pharmacokinetics of meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility. In this study, the investigator will detect drug concentration in both plasma and cerebrospinal fluid to construct population pharmacokinetics.
- Conditions
- Bacterial Meningitis, Augmented Renal Clearance
- Being tested
- meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid
- Medical subject headings
- Meningitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolidDrug
The use of antimicrobial agents depends on the clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid) | The use of antimicrobial agents depends on the clinical practice. Receives: Drug: meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
To detect the peak plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid after intravenous administration.
Measured: at (5-10) minutes after intravenous administration
The random plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
To detect the random plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid after intravenous administration.
Measured: at (0.5-10) hours after intravenous administration
The trough plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
To detect the trough plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid after intravenous administration.
Measured: at 1-2 hours before the next administration
Secondary outcomes (1)
clinical response
Blood routine examination, cerebrospinal fluid routine examination and infection indicators (C-reaction protein, procalcitonin)
Measured: Through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Oct 2020
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial MeningitisStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771884
- Sponsor's protocol ID
- 2021-ARC-002
- Status last verified
- Apr 2021
- First submitted
- 20 Feb 2021
- Last updated
- 13 Apr 2021
- 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 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance
- ClinicalTrials.gov ID
- NCT04771884
- Acronym / sponsor ID
- 2021-ARC-002
- Conditions
- Bacterial Meningitis, Augmented Renal Clearance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 25 Feb 2021 (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.
The investigator's purpose is to study the population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility.
Detailed description
The investigator's purpose is to study the population pharmacokinetics of meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility. In this study, the investigator will detect drug concentration in both plasma and cerebrospinal fluid to construct population pharmacokinetics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid) | – | Drug: meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolidThe use of antimicrobial agents depends on the clinical practice. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (2 months-18 years) of bacterial meningitis with augmented renal clearance
Key inclusion criteria (4 listed)
- Children have been diagnosed with bacterial meningitis with augmented renal clearance (eGFR ≥ 160 mL/(min*1.73m2));
- Age: 2 months-18 years;
- Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and/ or linezolid used as part of regular treatment;
- Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid was administered intravenously.
Key exclusion criteria (4 listed)
- Patients who die within the treatment cycle;
- Severe congenital malformation;
- Receive other systemic experimental drug therapy;
- Other factors that the researchers consider 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 |
|---|---|---|
| meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolidThe use of antimicrobial agents depends on the clinical practice | Drug | Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid) |
Primary outcome
The peak plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
Time frame: at (5-10) minutes after intravenous administration
To detect the peak plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid after intravenous administration.
The random plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
Time frame: at (0.5-10) hours after intravenous administration
To detect the random plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid after intravenous administration.
The trough plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
Time frame: at 1-2 hours before the next administration
To detect the trough plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid after intravenous administration.
1 secondary outcome
clinical response
Time frame: Through study completion, an average of 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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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 Bacterial Meningitis and Augmented Renal Clearance, 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 4 inclusion and 4 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 13 Apr 2021. 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, Phd (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 and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid. (time frame: at (5-10) minutes after intravenous administration). The study lists 3 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 13 Apr 2021.