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OpenTrials
Completed

NCT Number: NCT04404855

Antibiotic Selection Using Next Generation Sequencing vs Urine Culture

This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Audie Murphy VA Hospital, San Antonio, Texas, United States

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About this study

NGS will be performed on voided urine collected as routine care approximately 30 days prior to surgery. Results will be presented to Infectious Disease pharmacist within 48-72 hours to help select the most appropriate antibiotics, and independently as part of routine care, surgeons will choose the antibiotic that they would use in each case, while the Infectious Disease pharmacists would select their optimum choice. Approximately 220 subjects will be randomly assigned in a 1:1 ratio to receive either NGS antibiotic recommendation or standard of care (SOC) prophylaxis prescribed treatment. Subjects assigned to standard of care will have urine cultures sent for analysis, and the physician will choose antibiotics based on results as per usual practice. Subjects assigned to the NGS group, in addition to routine urine culture results, will have NGS urine culture results sent to an investigational drrug (ID) pharmacist, and recommendations will be shared with the physician to determine the antibiotic selection. The physician will ultimately decide the appropriate antibiotics to prescribe. Approximately 7-14 days after surgery, the research staff will conduct a telephone call to ask about any post-operative infections, complications, and any additional antibiotics that were prescribed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy or any other transurethral procedure
  • Age 18 or older
  • Able to give informed consent

Exclusion criteria

  • Unwilling or unable to provide informed consent
  • Age < 18
  • Does not meet inclusion criteria

Treatment and study plan

NGS + Antibiotic Recommendation

Other

NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist

Standard of Care treatment

Procedure

Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.

Primary outcomes

  1. Incidence of Infection Post Surgery

    Time frame: One to two weeks after surgery (approximately 100 days from baseline)

    Number of participants that develop post surgical infection

Secondary outcomes

  1. Number of Participants for Whom Additional Antibiotics Were Selected

    Time frame: Within 30 days of urine culture and date of surgery (approximately 100 days from baseline)

    The number of participants who required their antibiotic treatment to be augmented (additional antibiotic given) or escalated (broader-spectrum antibiotic chosen).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Microgen LLC

Registry information

Official study title

Randomized Clinical Trial Using Next Generation Microbial Sequencing to Direct Antibiotic Selection Before Kidney Stone Lithotripsy Using an Interprofessional Model

Acronym: ACCESS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 28, 2020
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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