ARIES: Antibiotic Resistance In Eye Surgeries

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04750655
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 33
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Antimicrobial Resistance (AMR) of Conjunctiva at 1 week [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94158

Sponsors and Collaborators

• University of California, San Francisco

Investigators

• Principal Investigator: Ying Han, MD, PhD, University of California, San Francisco
• Principal Investigator: Thuy Doan, MD, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04750655
• Other Study ID Numbers: IRB#20-30037
• First Posted: Feb 11, 2021
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Moxifloxacin

Study Results

No Results Posted as of Aug 4, 2022