Personalized Antibiotic Therapy - Point-of-Care Determina... | NCT07666230

Studies
Personalized Antibiotic Therapy - Point-of-Care Determination of Blood Levels of Beta-Lactam Antibiotics Using Coated-Blade-Spray Ion Mobility Spectrometry

NCT07666230

Sponsor

Dr. T. Perl

Status

Not yet recruiting

Last Update Posted

Jun 24, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Bacterial Infections

Interventions

Not provided

Countries

Not provided

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

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2026Estimated

Primary Completion Date

May 2029Estimated

Completion Date

May 2029Estimated

First Submitted Date

Jun 15, 2026

First Submission Date that Met QC Criteria

Jun 18, 2026

First Posted Date

Jun 24, 2026Actual

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

Jun 18, 2026

Last Update Posted Date

Jun 24, 2026Actual

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

A new analytical method for determining beta-lactam antibiotic concentrations in the blood of intensive care patients is to be evaluated. Patients receive antibiotic therapy with beta-lactam antibiotics in the general surgery intensive care unit. Blood samples are collected daily for routine clinical testing; a portion of these samples is used for the new method. The antibiotic levels, routinely measured using the gold standard, are documented and used as a reference point. The goal of the study is to establish a rapid and cost-effective method for determining beta-lactam antibiotic levels, which will subsequently enable rapid dose adjustment.

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood levels of beta-lactam antibiotics	Blood levels of beta-lactam antibiotics are measured both through routine clinical testing and using the newly developed analytical method. Blood samples are collected once a day for this purpose. Changes in blood levels are monitored over several days.	Daily, approximately 5-10 days from start of anibiotic therapy (and enrollment) to the end of antibiotic therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Valid informed consent form (prospective, retrospective, or provided by a legal representative)
Antibiotic therapy with a beta-lactam antibiotic in the intensive care unit or intermediate care unit of the Department of General Surgery at UMG

Exclusion Criteria:

Patients without a valid informed consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patents that are treated with beta-lactam antibiotics in the ICU or IMC unit of the Department of General Surgery at UMG

Sampling Method

Non-Probability Sample

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

Condition Browse Module

MeSH Terms

ID	Term
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided