Infectious Diseases of SpineNCT06711575
Model-informed Individualized Treatment of Anti-Infective Drugs in Patients With Spinal Infections
An observational study of Infectious Diseases of Spine, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to describe the population pharmacokinetic characteristics in patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy, and to evaluate effectiveness and safety of these drugs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Diseases of Spine
- What is being tested?
- Anti-Infective Drugs
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2024to 1 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy.
Who may be able to join
- Patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy.
Who cannot join
- Pregnant/lactating women.
- There are other factors that the researchers think are not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Public Health Clinical Center
Jinan
Qiang Zhang
About this study
The purpose of this study is to describe the population pharmacokinetic characteristics in patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy, and to evaluate effectiveness and safety of these drugs.
- Conditions
- Infectious Diseases of Spine
- Being tested
- Anti-Infective Drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Infective DrugsDrug
Anti-infective drugs are administered using the traditional clinical dosing regimen, with no interventions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance (L/h)
Measured: Through study completion, an average of 30 days
Volume of Distribution (L)
Measured: Through study completion, an average of 30 days
Secondary outcomes (3)
the ratio of the area under the concentration-time curve from 0 to 24 hours
For time-dependent antimicrobials, the PD target is defined as the time of free drug concentration beyond MIC during the dose interval. For concentration-dependent antimicrobials, the PD target is defined as the ratio of the area under the concentration-time curve from 0 to 24 hours to the MIC.
Measured: Through study completion, an average of 30 days
erythrocyte sedimentation rate
Clinical treatment outcome
Measured: Through study completion, an average of 30 days
Adverse events
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start12 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Diseases of SpineStudies 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
- Shandong Public Health Clinical Center
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
- Investigators
- Wei Zhao, Ph.D, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711575
- Sponsor's protocol ID
- SDU-2024-IDS-006
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-informed Individualized Treatment of Anti-Infective Drugs in Patients With Spinal Infections
- ClinicalTrials.gov ID
- NCT06711575
- Acronym / sponsor ID
- SDU-2024-IDS-006
- Conditions
- Infectious Diseases of Spine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Public Health Clinical Center
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 2 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.
The purpose of this study is to describe the population pharmacokinetic characteristics in patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy, and to evaluate effectiveness and safety of these drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy.
Key inclusion criteria (1 listed)
- Patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy.
Key exclusion criteria (2 listed)
- Pregnant/lactating women.
- There are other factors that the 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 |
|---|---|---|
| Anti-Infective DrugsAnti-infective drugs are administered using the traditional clinical dosing regimen, with no interventions. | Drug | – |
Primary outcome
Clearance (L/h)
Time frame: Through study completion, an average of 30 days
Volume of Distribution (L)
Time frame: Through study completion, an average of 30 days
3 secondary outcomes
the ratio of the area under the concentration-time curve from 0 to 24 hours
Time frame: Through study completion, an average of 30 days
erythrocyte sedimentation rate
Time frame: Through study completion, an average of 30 days
Adverse events
Time frame: Through study completion, an average of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Infectious Diseases of Spine
Enrolling by invitationObservational study
Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery
Intervertebral Disc Degeneration, Intervertebral Disc Displacement
RecruitingPhase 4
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
Wound Closure, Brain Tumor Adult
Recruiting
Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology
Radius; Deformity, Hip Osteoarthritis
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.
Wei Zhao, Ph.D principal investigator
Shandong University
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 Diseases of Spine, 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 1 inclusion and 2 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 2 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?
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 (8653188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance (L/h) (time frame: Through study completion, an average of 30 days). The study lists 2 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 2 Dec 2024.