Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-02 @ 3:48 AM
Study NCT ID:
NCT05276466
Status:
UNKNOWN
Last Update Posted:
2023-03-15
First Post:
2021-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Urinary Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) Technology in the Evaluation and Management of Females With Chronic Bladder Pain and Cystitis-like Symptoms
Sponsor:
MicroGenDX
Organization:
Study Overview
Official Title:
Assessment of Urinary Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) Technology in the Evaluation and Management of Females With Chronic Bladder Pain and Cystitis-like Symptoms
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Real-world clinical practice multicenter study to determine the clinical implications of employing PCR/NGS technology to identify and treat potential urinary pathogens in female participants identified with bladder pain and/or cystitis-like symptoms.
Detailed Description:
This is a real-world clinical practice multicenter study to determine the clinical implications of employing PCR/NGS technology to identify and treat potential urinary pathogens in female patients identified with BPS and/or CCS symptoms. Eligible subjects will undergo a baseline/screening visit at which time the following will be collected: demographics/history, physical examination, Numerical Rating Scale (NRS) pain (average and maximum), Female Genito-Urinary Pain Index (F-GUPI), Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index (ICSI/ICPI), Acute Cystitis Symptom Score (ACSS), and the Short Form -12.v2 Quality of Life Questionnaire (SF-12). MSU and catheterized urine specimens will be collected for urinalysis (UA), standard culture, and PCR/NGS. Subjects will be stratified based on BPS (NIDDK MAPP criteria) or CCS (based on ACSS criteria) symptoms.
Uropathogens detected on PCR/NGS catheterized specimens will be treated with 10 days of PCR/NGS directed antibiotic therapy which will be recommended by a centralized infectious disease consultant. If there are no uropathogenic bacteria in the catheter specimen, the MSU specimen will be used if positive. Prescribing physicians will adjust those recommendations (choice of antibiotic as well as duration of therapy) based on individual patient's history of antibiotic therapy and known allergies and sensitivities. Subjects with negative PCR/NGS findings for potential uropathogens will be treated with 10 days of empiric antibiotic therapy chosen by the investigator from this list b: 1. Trimethoprim sulfamethoxazole, 2. Macrocrystalline nitrofurantoin, 3. Fosfomycin, and 4. Investigator choice. More than one antibiotic may be prescribed if two or more uropathogens are identified. At the discretion of the treating physician with the consent and shared decision making with the patient, a decision may be made to continue antibiotic therapy beyond 10 days if the patient subjectively believes she is responding. In this study, all subjects will be offered antibiotic therapy, either NGS directed or empiric. Fourteen days after beginning antibiotics, the Subjective Global Assessment (SGA), compliance and safety will be determined via phone call. A clinic visit will be scheduled for 14 days after finishing antibiotics for repeat evaluation of symptoms (NRS pain, F-GUPI, ICSI/ICPI, ACSS, SF-12, SGA) and safety. A MSU urine specimen will be collected from all subjects and submitted for PCR/NGS analysis. Subjects who were PCR/NGS negative and failed empiric therapy will be notified that they likely do not have an infection. Primary analyses will be based on the responder rate (SGA responder rate will be the primary efficacy parameter), symptom change based on the other questionnaires, and safety in BPS/CCS subjects treated with PCR/NGS as well as those treated with empiric therapy. A 40% SGA responder rate, where a responder is defined as markedly or moderately improved on the GRA 7-point scale, will be considered a clinically significant impact. A follow-up visit 4 weeks later will collect similar data as collected at the efficacy visit.
Uropathogens detected on PCR/NGS catheterized specimens will be treated with 10 days of PCR/NGS directed antibiotic therapy which will be recommended by a centralized infectious disease consultant. If there are no uropathogenic bacteria in the catheter specimen, the MSU specimen will be used if positive. Prescribing physicians will adjust those recommendations (choice of antibiotic as well as duration of therapy) based on individual patient's history of antibiotic therapy and known allergies and sensitivities. Subjects with negative PCR/NGS findings for potential uropathogens will be treated with 10 days of empiric antibiotic therapy chosen by the investigator from this list b: 1. Trimethoprim sulfamethoxazole, 2. Macrocrystalline nitrofurantoin, 3. Fosfomycin, and 4. Investigator choice. More than one antibiotic may be prescribed if two or more uropathogens are identified. At the discretion of the treating physician with the consent and shared decision making with the patient, a decision may be made to continue antibiotic therapy beyond 10 days if the patient subjectively believes she is responding. In this study, all subjects will be offered antibiotic therapy, either NGS directed or empiric. Fourteen days after beginning antibiotics, the Subjective Global Assessment (SGA), compliance and safety will be determined via phone call. A clinic visit will be scheduled for 14 days after finishing antibiotics for repeat evaluation of symptoms (NRS pain, F-GUPI, ICSI/ICPI, ACSS, SF-12, SGA) and safety. A MSU urine specimen will be collected from all subjects and submitted for PCR/NGS analysis. Subjects who were PCR/NGS negative and failed empiric therapy will be notified that they likely do not have an infection. Primary analyses will be based on the responder rate (SGA responder rate will be the primary efficacy parameter), symptom change based on the other questionnaires, and safety in BPS/CCS subjects treated with PCR/NGS as well as those treated with empiric therapy. A 40% SGA responder rate, where a responder is defined as markedly or moderately improved on the GRA 7-point scale, will be considered a clinically significant impact. A follow-up visit 4 weeks later will collect similar data as collected at the efficacy visit.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: