NCT06711575

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Oct 2024Oct 2026

Study Start

First participant enrolled

October 12, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

December 2, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 28, 2024

Last Update Submit

November 29, 2024

Conditions

Infectious Diseases of Spine

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • the ratio of the area under the concentration-time curve from 0 to 24 hours

    Through study completion, an average of 30 days

  • erythrocyte sedimentation rate

    Through study completion, an average of 30 days

  • Adverse events

    Through study completion, an average of 30 days

Interventions

Anti-Infective DrugsDRUG

Anti-infective drugs are administered using the traditional clinical dosing regimen, with no interventions.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnant/lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Public Health Clinical Center

Jinan, China

RECRUITING

MeSH Terms

Interventions

Anti-Infective Agents

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Wei Zhao, Ph.D

    Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

8653188383308zhao4wei2@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of clinical pharmacy and pharmacology

Study Record Dates

First Submitted

October 28, 2024

First Posted

December 2, 2024

Study Start

October 12, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

December 2, 2024

Record last verified: 2024-10

Locations

CN(1)