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Antibiotic Resistance In Eye Surgeries (ARIES)

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ClinicalTrials.gov Identifier: NCT04750655
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : July 1, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE February 5, 2021
First Posted Date  ICMJE February 11, 2021
Last Update Posted Date July 1, 2021
Actual Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2021)
  • Antimicrobial Resistance (AMR) of Conjunctiva at 1 week [ Time Frame: 1 Week ]
    Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants from DNA deep sequencing for the conjunctival swabs at 1 week.
  • Antimicrobial Resistance (AMR) of Nasopharynx at 1 week [ Time Frame: 1 week ]
    Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants from DNA deep sequencing for the nasopharyngeal swabs at 1 week.
  • Antimicrobial Resistance (AMR) of Oral at 1 week [ Time Frame: 1 week ]
    Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants for the buccal swabs at 1 week.
  • Antimicrobial Resistance (AMR) of Gut at 1 Week [ Time Frame: 1 week ]
    Normalized reads counts (reads per million reads or rM) for fluoroquinolone resistance determinants for the rectal swabs at 1 week.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2021)
  • Ocular Surface Microbiome with Shannon's diversity index at 1 week [ Time Frame: 1 week ]
    Shannon's diversity index (H) will be measured to calculate species richness of ocular surface microbiome at 1 week. Shannon's diversity index (H) is calculated through the following formula, H = -sum(pi*log(b)*pi), where pi is the proportional abundance of species and b is the base of the logarithm.
  • Ocular Surface Microbiome with Simpson's diversity index at 1 week [ Time Frame: 1 week ]
    Simpson's diversity index (D) will be measured to calculate species richness of ocular surface microbiome at 1 week. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species.
  • Ocular Surface Microbiome with Shannon's diversity index at 1 month [ Time Frame: 1 month ]
    Shannon's diversity index (H) will be measured to calculate species richness of ocular surface microbiome at 1 month. Shannon's diversity index (H) is calculated through the following formula, H = -sum(pi*log(b)*pi), where pi is the proportional abundance of species and b is the base of the logarithm.
  • Ocular Surface Microbiome with Simpson's diversity index at 1 month [ Time Frame: 1 month ]
    Simpson's diversity index (D) will be measured to calculate species richness of ocular surface microbiome at 1 month. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species.
  • Nasopharyngeal Microbiome with Shannon's diversity index at 1 week [ Time Frame: 1 week ]
    Shannon's diversity index (H) will be measured to calculate species richness of nasopharyngeal microbiome at 1 week. Shannon's diversity index (H) is calculated through the following formula, H = -sum(pi*log(b)*pi), where pi is the proportional abundance of species and b is the base of the logarithm.
  • Nasopharyngeal Microbiome with Simpson's diversity index at 1 week [ Time Frame: 1 week ]
    Simpson's diversity index (D) will be measured to calculate species richness of nasopharyngeal microbiome at 1 week. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species.
  • Nasopharyngeal Microbiome with Shannon's diversity index at 1 month [ Time Frame: 1 month ]
    Shannon's diversity index (H) will be measured to calculate species richness of nasopharyngeal microbiome at 1 month. Shannon's diversity index (H) is calculated through the following formula, H = -sum(pi*log(b)*pi), where pi is the proportional abundance of species and b is the base of the logarithm.
  • Nasopharyngeal Microbiome with Simpson's diversity index at 1 month [ Time Frame: 1 month ]
    Simpson's diversity index (D) will be measured to calculate species richness of nasopharyngeal microbiome at 1 month. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species.
  • Gut Microbiome with Shannon's diversity index at 1 week [ Time Frame: 1 week ]
    Shannon's diversity index (H) will be measured to calculate species richness of gut microbiome at 1 week. Shannon's diversity index (H) is calculated through the following formula, H = -sum(pi*log(b)*pi), where pi is the proportional abundance of species and b is the base of the logarithm.
  • Gut Microbiome with Simpson's diversity index at 1 week [ Time Frame: 1 week ]
    Simpson's diversity index (D) will be measured to calculate species richness of gut microbiome at 1 week. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species.
  • Oral Microbiome with Shannon's diversity index at 1 Week [ Time Frame: 1 week ]
    Shannon's diversity index (H) will be measured to calculate species richness of oral microbiome at 1 week. Shannon's diversity index (H) is calculated through the following formula, H = -sum(pi*log(b)*pi), where pi is the proportional abundance of species and b is the base of the logarithm.
  • Oral Microbiome with Simpson's diversity index at 1 Week [ Time Frame: 1 week ]
    Simpson's diversity index (D) will be measured to calculate species richness of oral microbiome at 1 week. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species.
  • Oral Microbiome with Shannon's diversity index at 1 Month [ Time Frame: 1 month ]
    Shannon's diversity index (H) will be measured to calculate species richness of oral microbiome at 1 month. Shannon's diversity index (H) is calculated through the following formula, H = -sum(pi*log(b)*pi), where pi is the proportional abundance of species and b is the base of the logarithm.
  • Oral Microbiome with Simpson's diversity index at 1 Month [ Time Frame: 1 month ]
    Simpson's diversity index (D) will be measured to calculate species richness of oral microbiome at 1 month. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Resistance In Eye Surgeries
Official Title  ICMJE Antibiotic Resistance In Eye Surgeries (ARIES)
Brief Summary In this study, the investigators seek to determine the effect of antibiotic use post-surgery on antimicrobial resistance. The investigators will be studying adults (aged 18 or older) who will undergo eye surgery at University of California, San Francisco (UCSF). We seek to gain a better understanding of how antibiotic use during the perioperative period influences local and systemic antibiotic resistance at the individual level.
Detailed Description

Antibiotic use has saved millions of lives globally. However, this comes at the cost of selecting for antibiotic-resistant organisms at the individual and the community level. It is estimated that every year, approximately 700,000 deaths are associated with drug resistance globally. This places a significant burden on the public health system and the judicious use of antibiotics is more important than ever before.

The proposed masked, randomized controlled trial evaluates the effects of topical antibiotic use on the selection of antibiotic resistance determinants at the local and systemic levels. The results will provide guidance for antibiotic usage in ophthalmology and may have the potential to inform public health policies.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Antibiotic Resistance
  • Ocular Surface Microbiome
  • Gut Resistome
Intervention  ICMJE Drug: Moxifloxacin (Topical)
We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.
Study Arms  ICMJE
  • Placebo Comparator: Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics
    intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops
    Intervention: Drug: Moxifloxacin (Topical)
  • Active Comparator: Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week
    intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week
    Intervention: Drug: Moxifloxacin (Topical)
  • Active Comparator: Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week
    intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week
    Intervention: Drug: Moxifloxacin (Topical)
Publications * Gaynor BD, Chidambaram JD, Cevallos V, Miao Y, Miller K, Jha HC, Bhatta RC, Chaudhary JS, Osaki Holm S, Whitcher JP, Holbrook KA, Fry AM, Lietman TM. Topical ocular antibiotics induce bacterial resistance at extraocular sites. Br J Ophthalmol. 2005 Sep;89(9):1097-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 9, 2021)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Over 18 years of age
  2. Undergoing cataract surgeries that would benefit from intracameral antibiotics
  3. Able to provide swabs
  4. Able to provide consent
  5. Surgery of the second eye occurs at least 8 weeks after surgery of the first eye

Exclusion Criteria:

  1. Same-day bilateral cataract surgeries
  2. On immunosuppression medication such as Prednisone, Methotrexate, Cellcept, or anti-TNF inhibitors within past 3 months
  3. On systemic antibiotic within past 3 months
  4. On topical antibiotics within past 8 weeks
  5. Allergies to fluoroquinolone
  6. Patients needing glaucoma drainage device or trabeculectomy
  7. Inability to consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sean Yonamine, BA, BS 909-268-7390 sean.yonamine@ucsf.edu
Contact: Ying Han, MD, PhD 510-508-0940 ying.han@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04750655
Other Study ID Numbers  ICMJE IRB#20-30037
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ying Han, MD, PhD University of California, San Francisco
Principal Investigator: Thuy Doan, MD, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP