NCT02060513

Brief Summary

Military service members and the U.S. veteran population face a growing and serious health threat: widespread antibiotic resistance resulting from resistant bacteria and a dwindling pipe-line of sufficiently potent antibiotics. Infections with antibiotic resistant bacteria are increasing significantly. They cause major complications and mortality, and drive up healthcare costs. Powerful but non-targeted antibiotics, while in widespread use, can actually pressure bacteria to develop resistance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2016

Enrollment Period

3.3 years

First QC Date

February 3, 2014

Last Update Submit

December 5, 2025

Conditions

InfectionSkin and Subcutaneous Tissue Bacterial InfectionsHealthcare-associated InfectionInfection Due to Resistant Bacteria

Keywords

Wounded warriorsBattlefield infectionAcinetobacterESBLMRSAKPC

Outcome Measures

Primary Outcomes (1)

  • The proportion of concordant, accurately phenotyped positive isolates assayed by MADM versus conventional culture based microbiology as comparator.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients with a suspected infection.

You may qualify if:

  • Age ≥ 18 years old.
  • Microbiology culture (respiratory, blood or tissue/skin) ordered during regular clinical care.

You may not qualify if:

  • Insufficient sample volume available after clinical test completed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Denver Veterans Affairs Eastern Colorado Health Care System

Denver, Colorado, 80220, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Isolates of intresting bacteria

MeSH Terms

Conditions

InfectionsCross Infection

Condition Hierarchy (Ancestors)

Iatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Connie S Price, MD

    Denver Health Medical Center

    PRINCIPAL INVESTIGATOR

  • Ivor S Douglas, MD

    Denver Health Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 12, 2014

Study Start

August 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 12, 2025

Record last verified: 2016-12

Locations

US(3)