Model-informed Individualized Treatment of Anti-Infective... | NCT06711575

Studies
Model-informed Individualized Treatment of Anti-Infective Drugs in Patients With Spinal Infections

NCT06711575

Sponsor

Shandong University

Status

Recruiting

Last Update Posted

Dec 2, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Infectious Diseases of Spine

Interventions

Anti-Infective Drugs

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2024Actual

Primary Completion Date

Oct 1, 2026Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Oct 28, 2024

First Submission Date that Met QC Criteria

Nov 29, 2024

First Posted Date

Dec 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2024

Last Update Posted Date

Dec 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Zhao, Head of department of clinical pharmacy and pharmacology, Shandong UniversityPrincipal Investigator

Lead Sponsor

Shandong UniversityOTHER

Collaborators

Name	Class
Shandong Public Health Clinical Center	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-Infective Drugs	Drug	Anti-infective drugs are administered using the traditional clinical dosing regimen, with no interventions.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clearance (L/h)		Through study completion, an average of 30 days
Volume of Distribution (L)		Through study completion, an average of 30 days

Secondary Outcomes

Measure	Description	Time Frame
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.	Through study completion, an average of 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy.

Exclusion Criteria:

Pregnant/lactating women.
There are other factors that the researchers think are not suitable for inclusion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Zhao, Ph.D	Contact	8653188383308		zhao4wei2@hotmail.com

Overall Officials

Name	Affiliation	Role
Wei Zhao, Ph.D	Shandong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shandong Public Health Clinical Center	Recruiting	Jinan			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000890	Anti-Infective Agents

Ancestor Terms

ID	Term
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided