Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Antibiotics · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Age 6 to < 12 years | EXPERIMENTAL | Participants will receive meropenem-vaborbactam via an IV infusion for a minimum of 3 days, for up to 14 days. Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3. |
| Cohort 2: Age 2 to < 6 years | EXPERIMENTAL | Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days. Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3. |
| Cohort 3: Age 3 months to < 2 years | EXPERIMENTAL | Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days. Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3. |
| Name | Type | Description |
|---|---|---|
| Meropenem-Vaborbactam | DRUG | Administered as specified in the treatment arm |
| Antibiotics | DRUG | Administered as prescribed by the study physician in accordance with local guidelines and regulations. |
Key Inclusion Criteria: * Have a clinically suspected and/or bacteriologically documented cUTI or AP judged by the Investigator to require hospitalization for treatment with at least 3 days of IV antibiotics. * Evidence of pyuria, confirmed by either of the following: * A urine specimen that is ...
Antibiotics is an investigational small molecule being developed for Acute Pyelonephritis, a type of complicated urinary tract infection. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in a controlled clinical trial to evaluate its safety, tolerability, and pharmacokinetics.
Antibiotics is a combination of meropenem and vaborbactam. Meropenem is a carbapenem antibiotic that targets bacterial cell wall synthesis, while vaborbactam is a beta-lactamase inhibitor that protects meropenem from degradation by resistant bacteria. This combination is designed to treat infections caused by resistant gram-negative bacteria.
Antibiotics is being developed by CorMedix Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol CRMD. The company is conducting a Phase 2 clinical trial to evaluate the drug for the treatment of Acute Pyelonephritis in pediatric patients.
Antibiotics is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is recruiting participants to study the drug's safety, tolerability, and pharmacokinetics in children with complicated urinary tract infections, including Acute Pyelonephritis.
Antibiotics is being studied in a single Phase 2 clinical trial with the identifier NCT06672978. This trial is recruiting 66 participants aged 3 months and older in the United States, Bulgaria, Croatia, Georgia, Greece, and Poland. The study is controlled but not randomized or double-blinded, and it is actively recruiting patients.