Antibiotic Resistance In Eye Surgeries

Phase 4

• Conditions: Ocular Surface Microbiome; Antibiotic Resistance; Gut Resistome
• Interventions: Drug: Moxifloxacin (Topical)

• Registration Number: NCT04750655
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-11
• Study Start: 2021-03-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week	Moxifloxacin (Topical)	intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week
Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics	Moxifloxacin (Topical)	intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops
Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week	Moxifloxacin (Topical)	intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States