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OpenTrials
Completed

NCT Number: NCT02623179

Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

In this protocol, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C & S testing for patients with both complicated and uncomplicated UTIs. The investigators will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3) quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms; and 4) overall cost.

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Key information

Conditions

Urinary Tract Infections-UTI

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Age greater than or equal to 18 and less than or equal to 89 years.
  • The PI suspects the patient has a complicated or uncomplicated UTI that requires urine testing to confirm diagnosis
  • Able to provide at least 8 ml urine total (urine for 2 pathology tests).
  • Is willing to complete one follow up surveys and send back to FH.

Exclusion criteria

  • • Unable or unwilling to provide written informed consent.
  • Unable to read and write English (surveys are not available or validated in any other language than English).
  • Currently on any antibiotic for any clinical indication.

Treatment and study plan

culture versus Molecular diagnostics

Other

Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table

Primary outcomes

  1. To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies.

    Time frame: 1 year

    comparison of culture and sensitivity results to the molecular results

Secondary outcomes

  1. Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results

    Time frame: 1 year

    time from collection of sample to diagnostic result delivery

  2. Time from participant reported start of UTI symptoms to resolution.

    Time frame: 1 year

    collect time of reported UTI from Subject

  3. Participant Quality of Life as measured by a UTI specific severity and bothersome of symptoms survey taken at baseline (at clinic visit) and at set time points post urine testing

    Time frame: 1 year

    collect data from Subject as outlined in the Quality of Life Assessment

  4. Overall cost

    Time frame: 1 year

    collect data on the overall cost of Subject treatment

Sponsors and collaborators

Lead sponsor

Southwest Regional PCR, LLC

Industry

Registry information

Official study title

Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2015
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.