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Also known as sulopenem etzadroxil and probenecid
Sulopenem-Etzadroxil/Probenecid · 2 trials · 2 indications
Clinical response is defined as resolution in signs and symptoms of the index infection and no new symptoms, without the need for additional antibiotics or interventions
Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen)
| Arm | Type | Description |
|---|---|---|
| Sulopenem | EXPERIMENTAL | Sulopenem 1000 mg IV once daily for at least 5 days, followed by Sulopenem-Etzadroxil/Probenecid 500 mg PO twice daily to complete 7-10 days of treatment |
| Ertapenem | ACTIVE_COMPARATOR | Ertapenem 1000 mg IV once daily for at least 5 days, followed by ciprofloxacin 500 mg PO twice daily along with metronidazole 500 mg PO four times daily. If patient is found to have causative pathogens that are resistant to ciprofloxacin they will receive amoxicillin-clavulanate 875 mg PO twice daily instead |
| Sulopenem-etzadroxil/probenecid | EXPERIMENTAL | Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days |
| Ciprofloxacin | ACTIVE_COMPARATOR | Ciprofloxacin 250 mg PO administered twice daily for 3 days |
| Name | Type | Description |
|---|---|---|
| Ertapenem | DRUG | Antibiotic for complicated intra-abdominal infection |
| Sulopenem-Etzadroxil/Probenecid | DRUG | Antibiotic for complicated intra-abdominal infection |
| Ciprofloxacin | DRUG | Antibiotic for complicated intra-abdominal infection |
| Metronidazole | DRUG | Antibiotic for complicated intra-abdominal infection |
| Amoxicillin-Clavulanate | DRUG | Antibiotic for complicated intra-abdominal infection |
| Sulopenem | DRUG | Antibiotic for complicated intra-abdominal infection |
Inclusion Criteria: 1. Patient or the patient's legally acceptable representative able to provide a signed written informed consent prior to any study-specific procedures. 2. Adult patients ≥18 years of age 3. EITHER: a. Intra-operative/post-operative enrollment with visual confirmation (presen...
Sulopenem etzadroxil/probenecid is an investigational oral antibiotic being studied for the treatment of urinary tract infections, including uncomplicated urinary tract infections and cystitis, as well as complicated intra-abdominal infections. It is currently in Phase 3 clinical development for these infectious disease indications.
Sulopenem etzadroxil/probenecid is being developed by Iterum Therapeutics plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol ITRM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating bacterial infections.
Sulopenem etzadroxil/probenecid is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials are evaluating its efficacy and safety compared to active control antibiotics in patients with urinary tract infections and intra-abdominal infections.
Sulopenem etzadroxil/probenecid has been studied in several clinical trials. NCT03354598 compared it to ciprofloxacin for uncomplicated urinary tract infection in adult women. NCT03358576 evaluated it against ertapenem for complicated intra-abdominal infection. NCT05584657 tested it versus amoxicillin/clavulanate for uncomplicated urinary tract infection. NCT07092813 is a Phase 1 pharmacokinetic study in adolescents.
Yes, Sulopenem etzadroxil/probenecid is the same as sulopenem etzadroxil and probenecid. The drug is a combination product containing both sulopenem etzadroxil and probenecid, which are administered together orally. This combination is being studied for its effectiveness in treating bacterial infections.
Sulopenem etzadroxil/probenecid is a small molecule antibiotic. It combines sulopenem etzadroxil, a prodrug of the penem antibiotic sulopenem, with probenecid, which helps increase the levels of sulopenem in the body. The drug is being studied for its ability to treat infections caused by susceptible bacteria.