Urinary Tract Infections-UTI Clinical Trial
Official title:
Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes
| Verified date | October 2017 |
| Source | Southwest Regional PCR, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 31, 2016 |
| Est. primary completion date | December 31, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 89 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Southwest Regional PCR, LLC |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies. | comparison of culture and sensitivity results to the molecular results | 1 year | |
| Secondary | Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results | time from collection of sample to diagnostic result delivery | 1 year | |
| Secondary | Time from participant reported start of UTI symptoms to resolution. | collect time of reported UTI from Subject | 1 year | |
| Secondary | 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 | collect data from Subject as outlined in the Quality of Life Assessment | 1 year | |
| Secondary | Overall cost | collect data on the overall cost of Subject treatment | 1 year |