NCT01388114

Brief Summary

The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor for serum PCT level measurement will offer a test with lower cost, and increase the applicability of serum Procalcitonin (PCT) level in daily clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable sepsis

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

July 1, 2011

Last Update Submit

November 15, 2012

Conditions

Sepsis

Keywords

Procalcitonin Measurement

Outcome Measures

Primary Outcomes (1)

  • Performance of e- Ab sensor for serum PCT level measurement

    The serum procalcitonin level from e- Ab sensor would be compared with the results from Kryptor assay system, Brahms, Germany. The correlation between serum procalcitonin levels from e- Ab sensor and from Kryptor assay system would be examined.

    1 Day

Study Arms (1)

Electrosensing antibody probing system (e- Ab sensing)

EXPERIMENTAL
Device: Electrosensing Antibody Probe System (e- Ab sensing)

Interventions

Electrosensing Antibody Probe System (e- Ab sensing)DEVICE

Electrosensing antibody probing system (e- Ab sensing), which was developed for the rapid and sensitive detection of hapten, proteins or viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-procalcitonin antibody and procalcitonin in the serum of the patients. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds procalcitonin polypeptide target molecules in the test specimen

Electrosensing antibody probing system (e- Ab sensing)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are admitted to medical intensive care units

You may not qualify if:

  • Patients who refuse consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hosital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chao-Chi Ho, MD, PhD

    National Taiwan Universtiy Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 6, 2011

Study Start

November 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 16, 2012

Record last verified: 2012-11

Locations

TW(1)