- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04750655
Antibiotic Resistance In Eye Surgeries (ARIES)
Antibiotic Resistance In Eye Surgeries (ARIES)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Sean Yonamine, BA, BS
- Phone Number: 909-268-7390
- Email: sean.yonamine@ucsf.edu
Study Contact Backup
- Name: Ying Han, MD, PhD
- Phone Number: 510-508-0940
- Email: ying.han@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- Recruiting
- University of California, San Francisco
-
Contact:
- Sean Yonamine, BA, BS
- Phone Number: 909-268-7390
- Email: sean.yonamine@ucsf.edu
-
Contact:
- Ying Han, MD, PhD
- Phone Number: 510-508-0940
- Email: ying.han@ucsf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics
intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops
|
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
|
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
|
We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery.
Frequency of postoperative antibiotics dependent on group randomization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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.
|
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.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 week
|
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.
|
1 week
|
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.
|
1 month
|
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.
|
1 month
|
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.
|
1 week
|
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.
|
1 week
|
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.
|
1 month
|
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.
|
1 month
|
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.
|
1 week
|
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.
|
1 week
|
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.
|
1 week
|
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.
|
1 week
|
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.
|
1 month
|
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.
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ying Han, MD, PhD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#20-30037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Antibiotic Resistance
-
Nantes University HospitalCompleted
-
University Hospital, AkershusOslo University Hospital; Helse Stavanger HF; Sorlandet Hospital HF; Sykehuset... and other collaboratorsTerminatedAntibiotic Drug Resistance
-
Uppsala UniversityKarolinska University Hospital; Sahlgrenska University Hospital, Sweden; University... and other collaboratorsRecruiting
-
University of British ColumbiaRecruiting
-
University of British ColumbiaTerminated
-
University of Southern DenmarkCompleted
-
Kufa UniversityCompleted
-
University of OxfordLondon School of Hygiene and Tropical Medicine; University College, London; KEMRI-Wellcome... and other collaboratorsUnknownAntibiotic Resistance | Malnutrition Severe | Antibiotic ToxicityKenya, Uganda
-
University of MichiganCompletedMulti-antibiotic ResistanceUnited States
-
Association Clinique Thérapeutique Infantile du...PfizerRecruitingAntibiotic Prescription | Complications | Risk Factors | Outcome, Fatal | Intensive Care Unit | Multi-antibiotic Resistance | Infection Due to Resistant Bacteria | Healing | Hospital DischargeFrance
Clinical Trials on Moxifloxacin (Topical)
-
Universidad de AntioquiaINNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES... and other collaboratorsWithdrawnLeishmaniasis, CutaneousColombia
-
Novan, Inc.CompletedAcne VulgarisUnited States
-
Stanford UniversityUniversity of Pennsylvania; University of California, Davis; Oregon Health and... and other collaboratorsRecruiting
-
Abramson Cancer Center of the University of PennsylvaniaCompletedCutaneous T Cell LymphomaUnited States
-
Rhodes Pharmaceuticals, L.P.ORA, Inc.Completed
-
Glia, LLCCompletedContact Lens Discomfort | Contact Lens-induced Corneal Disorder | Contact Lens Acute Red Eye | Contact Lens-induced Corneal Fluorescein StainingUnited States
-
Taro Pharmaceuticals USACompletedScalp PsoriasisUnited States
-
University Hospitals Coventry and Warwickshire...University Hospital, GenevaTerminatedTopical Corticosteroid-treated Dermatology Patients | Intra-ocular PressureUnited Kingdom
-
Amazentis SAproDERM GmbHCompleted
-
Amazentis SAproDERM GmbHCompletedErythema | Skin Inflammation | Sun Damaged SkinGermany