February 5, 2021

February 11, 2021

July 1, 2021

March 1, 2021

December 2023 (Final data collection date for primary outcome measure)

 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.

Same as current


 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.

Same as current

Not Provided

Not Provided


Antibiotic Resistance In Eye Surgeries

Antibiotic Resistance In Eye Surgeries (ARIES)

In this study, the investigators seek to determine the effect of antibiotic use postsurgery 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.

Antibiotic use has saved millions of lives globally. However, this comes at the cost of selecting for antibioticresistant 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.

Interventional

Phase 4

Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment

 Antibiotic Resistance
 Ocular Surface Microbiome
 Gut Resistome

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.

 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)

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):10979.


Recruiting

108

Same as current

December 2023

December 2023 (Final data collection date for primary outcome measure)

Inclusion Criteria:
 Over 18 years of age
 Undergoing cataract surgeries that would benefit from intracameral antibiotics
 Able to provide swabs
 Able to provide consent
 Surgery of the second eye occurs at least 8 weeks after surgery of the first eye
Exclusion Criteria:
 Sameday bilateral cataract surgeries
 On immunosuppression medication such as Prednisone, Methotrexate, Cellcept, or antiTNF inhibitors within past 3 months
 On systemic antibiotic within past 3 months
 On topical antibiotics within past 8 weeks
 Allergies to fluoroquinolone
 Patients needing glaucoma drainage device or trabeculectomy
 Inability to consent

Sexes Eligible for Study: 
All 

18 Years to 85 Years (Adult, Older Adult)

No


United States



NCT04750655

IRB#2030037

Yes

Studies a U.S. FDAregulated Drug Product: 
Yes 
Studies a U.S. FDAregulated Device Product: 
No 
Product Manufactured in and Exported from the U.S.: 
No 


University of California, San Francisco

University of California, San Francisco

Not Provided

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

University of California, San Francisco

June 2021
