NextGen - Clinical Implication of Next Generation Sequencing

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jan 11, 2022

Keywords

ClinConnect Summary

The NextGen clinical trial is studying new methods for detecting bacteria in urine, specifically for women with urinary tract infections (UTIs). This trial is looking at advanced techniques like Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS), which can identify bacteria more accurately than traditional urine cultures, especially when the number of bacteria is low (less than 10,000). This could be very helpful for women who might not have a clear diagnosis using standard tests.

To participate in this study, you need to be a female aged 18 or older with a urine culture showing fewer than 10,000 bacteria. You should be willing to attend all follow-up visits and be able to provide a clean urine sample. However, if you are currently using a catheter, have taken antibiotics in the last two weeks, are pregnant, or are incarcerated, you won't be eligible to join. If you qualify and choose to participate, you'll be contributing to important research that could improve how UTIs are diagnosed and treated in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • Incarcerated