Antibiotic Resistance In Eye Surgeries

NCT04750655 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB#20-30037
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic Resistance; Ocular Surface Microbiome; Gut Resistome

Outcome Measures

Primary Outcomes (1)

• 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, which represent the abundance of resistance in the sample.

  1 Week

Secondary Outcomes (4)

• Antimicrobial Resistance (AMR) of Nasopharynx at 1 Week

  1 week

• Shannon's Index

  1 week

• Simpson's Index

  1 week

• Simpson's Index

  1 week

Study Arms (3)

Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics

PLACEBO COMPARATOR

intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops

Drug: Moxifloxacin (Topical)

Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week

ACTIVE COMPARATOR

intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week

Drug: Moxifloxacin (Topical)

Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week

ACTIVE COMPARATOR

intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week

Drug: Moxifloxacin (Topical)

Interventions

Moxifloxacin (Topical) DRUG

We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.

Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics; Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week; Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Same-day bilateral cataract surgeries
• On immunosuppression medication such as Prednisone, Methotrexate, Cellcept, or anti-TNF 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related 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. doi: 10.1136/bjo.2005.068981.

  PMID: 16113356 BACKGROUND

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Limited generalization given enrollment was at a single tertiary center.

Results Point of Contact

• Title: Ying Han
• Organization: University of California, San Francisco

ying.han@ucsf.edu

(415) 353-2020

Study Officials

• Ying Han, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Thuy Doan, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 11, 2021
• Study Start: March 1, 2021
• Primary Completion: August 10, 2023
• Study Completion: August 31, 2023
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)