Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Doripenem · 7 trials · 13 indications
Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Doripenem 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion |
| 002 | ACTIVE_COMPARATOR | Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion |
| 003 | EXPERIMENTAL | Doripenem 1 gram infused over 4 hours at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion |
| 004 | ACTIVE_COMPARATOR | Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion |
| Name | Type | Description |
|---|---|---|
| doripenem | DRUG | - |
| Imipenem/cilastatin | DRUG | Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion |
Inclusion Criteria: * Patient has received mechanical ventilation for \> 24 hours * Presence of a new or progressive infiltrate on chest x-ray Exclusion Criteria: * Believed at study entry to have ventilator-associated pneumonia caused solely by pathogen(s) resistant to certain antibiotics * Hist...
Doripenem is a small molecule antibiotic used for bacterial infections, including complicated intra-abdominal infections, urinary tract infections, pneumonia, and ventilator-associated pneumonia. It is being developed by Johnson & Johnson (JNJ) and is currently in Phase 1 clinical development for infectious disease indications.
Doripenem is being developed by Johnson & Johnson, which trades under the ticker JNJ. The drug is a small molecule antibiotic in Phase 1 clinical development for the treatment of bacterial infections, including pneumonia and urinary tract infections.
Doripenem is in Phase 1 clinical development. It has completed two Phase 3 trials, one Phase 2 trial, and one Phase 1 trial, but the current development stage is Phase 1. The drug is investigational and not yet approved for any indication.
Doripenem has been studied in several completed clinical trials. NCT00210938 and NCT00229060 were Phase 3 trials in complicated intra-abdominal infections, each enrolling over 470 patients. NCT00515034 was a Phase 2 safety study in abdominal infections or pneumonia, and NCT01381848 was a Phase 1 study in infants under 12 weeks of age.
Doripenem is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. While it has completed Phase 3 trials, the drug remains in clinical testing and has not received approval from the FDA or any other regulatory authority.
Doripenem has been studied for bacterial infections, including complicated intra-abdominal infections such as appendicitis, cholecystitis, pancreatitis, and peritonitis. It has also been investigated for pneumonia, including ventilator-associated pneumonia, and for use in infants with bacterial infections.