NextGen - Clinical Implication of Next Generation Sequencing
ConditionUrinary Tract Infections
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorWake Forest University Health Sciences
About this trial
Recently more advanced techniques, including Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) are available to detect bacteria in urine based on bacterial genomes. Comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with Colony Count of less than 10,000 and more than zero.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female at least 18 years of age
U/C (Urinary Culture) growth of <10,000 Colony-Forming Units (CFU)
Understanding and acceptance of the need to return for all scheduled follow-up visits
Able to give informed consent
Disqualifiers
Catheter in use (Foley or suprapubic or intermittent)
Not able to provide clean midstream urine
Antibiotic consumption in the past 2 weeks before signing the consent
Pregnant or Planning to Conceive
Trial design
Design model
Single group
Treatments tested in this trial
Antibiotic
DrugFDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC \>0 and \<10,000
Next Gen
DeviceNext Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Symptomatic Patients with low Colony CountOther 2 interventions
Trial outcomes
Primary outcomes
1
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria \<10,000. Result Measure: NGS CC 100 to 10,000
Time frame
Baseline2
Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria \<10,000, Result Measure: NGS CC 100 to 10,000
Time frame
3 Weeks Post-TreatmentSecondary outcomes
1
Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000
NGS result focused antibiotic treatment and symptom outcome with the measurement of King's Questionnaire Outcome. Result Measure: Mild, Moderate, and Severe UTI symptoms in last 12 and 24 hours on 7 questions with no symptoms as "0", Mild as "1", Moderate as "2", and Severe as "3"
Time frame
Baseline2
Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000
NGS result focused antibiotic treatment and symptom outcome with the measurement of King's Questionnaire Outcome. Result Measure: Mild, Moderate, and Severe UTI symptoms in last 12 and 24 hours on 7 questions with no symptoms as "0", Mild as "1", Moderate as "2", and Severe as "3"
Time frame
3 Weeks Post-TreatmentSponsors and contacts
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Source ClinicalTrials.gov