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Zoliflodacin for Gonorrhea
Study Summary
This trial is testing whether a new oral drug for gonorrhea is as effective and safe as the current standard treatment.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have received chemotherapy or radiation treatment within the past 30 days.You have a history of alcohol or drug abuse within the past year that could affect your ability to participate in the trial, according to the investigator's judgment.You have had a serious allergic reaction to certain types of antibiotics like cephalosporin, penicillin, or macrolides.You have a heart condition that can cause irregular heartbeats or a prolonged QT interval, which can be risky.The text states that the age requirement for enrollment is 12 years old or older, provided that the local regulations and ethics guidance allow for it.
- Group 1: ceftriaxone and azithromycin combination
- Group 2: zoliflodacin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- 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
Are there any short or long term dangers associated with zoliflodacin?
"Zoliflodacin safety is estimated to be a 3. This number comes from the fact that zoliflodacin is in Phase 3 of clinical trials."
What infections does zoliflodacin typically kill?
"Zoliflodacin is a medication used to treat various infections, such as those located in the abdomen or caused by genus chlamydia. Additionally, it can be given to adult patients suffering from streptococcus agalactiae infection."
Are there other zoliflodacin studies that have already been completed?
"Zoliflodacin was first trialled a decade ago at Copsac, DBAC. Since then, there have been 289 completed studies and presently 72 clinical trials are actively recruiting patients. A high concentration of these active trials are based in Indianapolis, Indiana."
Are they currently looking for more participants in this trial?
"That is correct, the clinical trial listed on clinicaltrials.gov is currently recruiting patients. The posting dates of this particular trial are from 11/6/2019-11/7/2022 and they are looking for 1092 participants at 3 locations."
How many people are currently being enrolled in this trial?
"Yes, this is an ongoing study that is still looking for enrolment from patients. The clinical trial was first posted on 11/6/2019 and the latest update was on 11/7/2022. They are expecting to have 1092 participants between 3 sites."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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