Intracranial InfectionNCT06729619
Concentration Monitoring of Anti-infective Drugs in Human Cerebrospinal Fluid and Its Clinical Application
An observational study of Intracranial Infection and Central Infection, run by Xueyan Cui at 1 site in China.
Trial summary
At least 50 patients with intracranial infection receiving anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime and avibactam were included in each group for pharmacokinetic study, and the outcomes and adverse events of intracranial infection treatment were observed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Infection, Central Infection
- What is being tested?
- The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined.
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2024to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample size of patients with central infection was collected from November 2023 to the completion. Recruitment location: First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province). Research time: 2023-2026.
Who may be able to join
- Age ≥18 years old;
- clinically diagnosed as central infection (cerebrospinal fluid culture is positive with clinical infection symptoms) or suspected as central infection (abnormal cerebrospinal fluid examination, such as hypoglycemia, \< 50%; High protein, \> 50 mg/dl; The number of cells increased with clinical infection symptoms, but no cerebrospinal fluid culture was positive)
- receiving anti-infection treatment such as vancomycin or meropenem or linezolid or cefoperazone sulbactam;
- Sign the informed consent form.
Who cannot join
- There is no cerebrospinal fluid to determine the concentration;
- allergic to drugs;
- Other factors that researchers think are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong Provincial, 250014
About this study
At least 50 patients with intracranial infection receiving anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime and avibactam were included in each group for pharmacokinetic study, and the outcomes and adverse events of intracranial infection treatment were observed.
Read the detailed description
This study intends to establish a high performance liquid phase method to determine the concentration of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime abvibactam and other anti-infective drugs in cerebrospinal fluid, determine the concentration of cerebrospinal fluid in patients with central infection, and simultaneously determine the concentration of blood drugs at the same time point, optimize the clinical treatment plan by combining the concentration of cerebrospinal fluid and blood drugs, and explore the optimal concentration range of cerebrospinal fluid. At the same time, it can improve the cure rate of central infection, shorten the course of treatment and reduce the occurrence of adverse reactions.
- Conditions
- Intracranial Infection, Central Infection
- Being tested
- The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined.
- Keywords
- Intracranial infection, Cerebrospinal fluid concentration, Anti-infective drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined.Drug
Blood and cerebrospinal fluid concentrations of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam and ceftazidime ababactam will be monitored after the drug reaches a steady state.
| Study group | Role | What they receive |
|---|---|---|
| Patients with central infection | Not described Receives: Drug: The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal fluid concentration of anti-infective drugs
We will establish a methodology for determining the concentrations of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam and ceftazidime ababactam in cerebrospinal fluid by high performance liquid chromatography, and determine the drug concentrations in cerebrospinal fluid of patients with central infection, and simultaneously determine the blood drug concentrations at the same time point.
Measured: 2023-2026
Secondary outcomes (2)
The incidence of adverse events caused by treatment
In a clinical trial, the probability of an unexpected and adverse medical event that occurs after a patient or clinical subject receives a trial drug, but it does not necessarily have a causal relationship with the treatment.
Measured: 2023-2026
Treatment outcome of central infection
If there are blood routine tests, cerebrospinal fluid tests and procalcitonin tests before and after drug treatment, relevant information, combined drugs and adverse events will be collected to evaluate the effectiveness and safety of drug treatment for central infection.
Measured: 2023-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start3 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xueyan Cui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xueyan Cui, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729619
- Sponsor's protocol ID
- QFS-CXY-2023-ZSGR-001
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentration Monitoring of Anti-infective Drugs in Human Cerebrospinal Fluid and Its Clinical Application
- ClinicalTrials.gov ID
- NCT06729619
- Acronym / sponsor ID
- QFS-CXY-2023-ZSGR-001
- Conditions
- Intracranial Infection, Central Infection
- Keywords
- Intracranial infection, Cerebrospinal fluid concentration, Anti-infective drugs
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xueyan CuiUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Dec 2024 (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.
At least 50 patients with intracranial infection receiving anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime and avibactam were included in each group for pharmacokinetic study, and the outcomes and adverse events of intracranial infection treatment were observed.
Detailed description
This study intends to establish a high performance liquid phase method to determine the concentration of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime abvibactam and other anti-infective drugs in cerebrospinal fluid, determine the concentration of cerebrospinal fluid in patients with central infection, and simultaneously determine the concentration of blood drugs at the same time point, optimize the clinical treatment plan by combining the concentration of cerebrospinal fluid and blood drugs, and explore the optimal concentration range of cerebrospinal fluid. At the same time, it can improve the cure rate of central infection, shorten the course of treatment and reduce the occurrence of adverse reactions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with central infection | – | Drug: The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size of patients with central infection was collected from November 2023 to the completion. Recruitment location: First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province). Research time: 2023-2026.
Key inclusion criteria (4 listed)
- Age ≥18 years old;
- clinically diagnosed as central infection (cerebrospinal fluid culture is positive with clinical infection symptoms) or suspected as central infection (abnormal cerebrospinal fluid examination, such as hypoglycemia, \< 50%; High protein, \> 50 mg/dl; The number of cells increased with clinical infection symptoms, but no cerebrospinal fluid culture was positive)
- receiving anti-infection treatment such as vancomycin or meropenem or linezolid or cefoperazone sulbactam;
- Sign the informed consent form.
Key exclusion criteria (3 listed)
- There is no cerebrospinal fluid to determine the concentration;
- allergic to drugs;
- Other factors that researchers think are not suitable 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 |
|---|---|---|
| The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined.Blood and cerebrospinal fluid concentrations of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam and ceftazidime ababactam will be monitored after the drug reaches a steady state. | Drug | Patients with central infection |
Primary outcome
Cerebrospinal fluid concentration of anti-infective drugs
Time frame: 2023-2026
We will establish a methodology for determining the concentrations of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam and ceftazidime ababactam in cerebrospinal fluid by high performance liquid chromatography, and determine the drug concentrations in cerebrospinal fluid of patients with central infection, and simultaneously determine the blood drug concentrations at the same time point.
2 secondary outcomes
The incidence of adverse events caused by treatment
Time frame: 2023-2026
Treatment outcome of central infection
Time frame: 2023-2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Intracranial Infection and Central Infection, run by Xueyan Cui 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 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cerebrospinal fluid concentration of anti-infective drugs (time frame: 2023-2026). 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 11 Dec 2024.