Antibiotic Resistance In Eye Surgeries

Antibiotic Resistance Clinical Trial

— ARIES  

Official title:

Antibiotic Resistance In Eye Surgeries (ARIES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750655
• Other study ID #: IRB#20-30037
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: University of California, San Francisco
• Contact: Sean Yonamine, BA, BS
• Phone: 909-268-7390
• Email: sean.yonamine[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistance
• Gut Resistome
• Ocular Surface Microbiome

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antimicrobial Resistance (AMR) of Conjunctiva at 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.	1 Week
Primary	Antimicrobial Resistance (AMR) of Nasopharynx at 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.	1 week
Primary	Antimicrobial Resistance (AMR) of Oral at 1 week	Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants for the buccal swabs at 1 week.	1 week
Primary	Antimicrobial Resistance (AMR) of Gut at 1 Week	Normalized reads counts (reads per million reads or rM) for fluoroquinolone resistance determinants for the rectal swabs at 1 week.	1 week
Secondary	Ocular Surface Microbiome with Shannon's diversity index at 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.	1 week
Secondary	Ocular Surface Microbiome with Simpson's diversity index at 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.	1 week
Secondary	Ocular Surface Microbiome with Shannon's diversity index at 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.	1 month
Secondary	Ocular Surface Microbiome with Simpson's diversity index at 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.	1 month
Secondary	Nasopharyngeal Microbiome with Shannon's diversity index at 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.	1 week
Secondary	Nasopharyngeal Microbiome with Simpson's diversity index at 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.	1 week
Secondary	Nasopharyngeal Microbiome with Shannon's diversity index at 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.	1 month
Secondary	Nasopharyngeal Microbiome with Simpson's diversity index at 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.	1 month
Secondary	Gut Microbiome with Shannon's diversity index at 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.	1 week
Secondary	Gut Microbiome with Simpson's diversity index at 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.	1 week
Secondary	Oral Microbiome with Shannon's diversity index at 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.	1 week
Secondary	Oral Microbiome with Simpson's diversity index at 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.	1 week
Secondary	Oral Microbiome with Shannon's diversity index at 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.	1 month
Secondary	Oral Microbiome with Simpson's diversity index at 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.	1 month