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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

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.

Condition or disease Intervention/treatment Phase
Antibiotic Resistance Ocular Surface Microbiome Gut Resistome Drug: Moxifloxacin (Topical) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Antibiotic Resistance In Eye Surgeries (ARIES)
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Placebo Comparator: Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics
intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops
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.

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
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.

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
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750655


Contacts
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Contact: Sean Yonamine, BA, BS 909-268-7390 sean.yonamine@ucsf.edu
Contact: Ying Han, MD, PhD 510-508-0940 ying.han@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Sean Yonamine, BA, BS    909-268-7390    sean.yonamine@ucsf.edu   
Contact: Ying Han, MD, PhD    510-508-0940    ying.han@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Ying Han, MD, PhD University of California, San Francisco
Principal Investigator: Thuy Doan, MD, PhD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04750655    
Other Study ID Numbers: IRB#20-30037
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents