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Moxifloxacin (Topical) for Antibiotic Resistance in Eye Surgeries (ARIES Trial)
ARIES Trial Summary
This trial will study the effects of post-surgery antibiotic use on antimicrobial resistance in patients.
- Antibiotic Resistance
- Ocular Surface Microbiome
- Gut Microbiome Resistance
ARIES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowARIES Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ARIES Trial Design
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Who is running the clinical trial?
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- You require a surgical procedure for glaucoma, such as a glaucoma drainage device or trabeculectomy.You are allergic to fluoroquinolone antibiotics.You are planning to have cataract surgery and may need antibiotics during the procedure.
- Group 1: Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics
- Group 2: Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week
- Group 3: Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research initiative currently accepting new participants?
"Affirmative. The information accessible on clinicaltrials.gov points to this medical trial actively recruiting participants, with the original posting being made on March 1st 2021 and last edited August 2nd 2022. This study is searching for 108 volunteer patients from one location."
Can I enroll in this research study?
"To qualify for this study, prospective volunteers must have antibiotic resistance bacteria and be between 18-85 years old. The team is seeking a total of 108 enrollees."
What type of conditions are treated with a regimen of intraoperative antibiotics, followed by topical antibiotics four times daily for one week?
"Intraoperative antibiotics (Abx) and a postoperative topical antibiotic regime of four applications per day for seven days is the general prescription to treat bacterial conjunctivitis. Additionally, this treatment can be used in cases such as ocular bacterial infections, plague, or postsurgical complications."
Could you provide information regarding the efficacy of administering Intraoperative antibiotics (Abx) and Postoperative topical antibiotics four times a day for 1 week in past clinical studies?
"Currently, there are 22 clinical trials that focus on the efficacy of Intraoperative antibiotics (Abx) and Postoperative topical antibiotics four times a day for 1 week. Out of these investigations, 11 have reached Phase 3 and all 448 testing sites reside in Guangzhou, Guangdong."
Does the FDA approve of utilizing intraoperative antibiotics, followed by daily topical antibiotics for a week?
"The safety of intraoperative antibiotics (Abx) and post-operative topical antibiotic use four times daily for one week has been assessed at a level 3, which denotes approval by the FDA."
What aims does this investigation seek to accomplish?
"This trial will span one week and aims to evaluate the Antimicrobial Resistance (AMR) of Oral. Secondary outcomes include Nasopharyngeal Microbiome with Simpson's diversity index at 1 month, which is calculated through summing pi^2 where pi is the proportional abundance of species; Nasopharyngeal Microbiome with Simpson's diversity index at 1 week, which follows a similar calculation as above; and Ocular Surface Microbiome with Shannon's diversity index at 1 week, defined by -sum(pi*log(b)*pi), wherein b represents the base of the logarithm."
Are adults over 18 years old eligible for enrollment in this clinical trial?
"As specified by the admission requirements, this medical trial welcomes individuals aged between 18-85."
What is the maximum number of participants this research project can accommodate?
"Affirmative. According to the information hosted on clinicaltrials.gov, this research endeavour is presently seeking participation from individuals; it was posted on March 1st 2021 and updated most recently on August 2nd 2022. The trial requires 108 participants from a single medical facility."
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