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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-Culture and Sensitivity group | Active Comparator | Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table |
|
| B-Diagnosis by Molecular Testing | Active Comparator | Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| culture versus Molecular diagnostics | Other | Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time from participant reported start of UTI symptoms to resolution. |
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Inclusion Criteria:
• Age greater than or equal to 18 and less than or equal to 89 years.
Exclusion Criteria:
• Unable or unwilling to provide written informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Michael McDonald, MD | Florida Hospital Celebration Health | Principal Investigator |
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collect time of reported UTI from Subject |
| 1 year |
| 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 |
| Overall cost | collect data on the overall cost of Subject treatment | 1 year |