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 an investigational small molecule antibiotic being studied for the treatment of bacterial infections, including pneumonia, ventilator-associated pneumonia, urinary tract infections, and complicated intra-abdominal infections. It is developed by Johnson & Johnson (JNJ) and is in Phase 1 clinical development for infectious disease indications.
Doripenem is a carbapenem antibiotic that targets bacterial cell wall synthesis. It is being studied for its activity against a range of bacterial pathogens causing infections such as pneumonia, urinary tract infections, and intra-abdominal infections. The drug is in Phase 1 development by Johnson & Johnson (JNJ).
Doripenem is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently 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 is an investigational drug and has not been approved by regulatory authorities. Johnson & Johnson (JNJ) is the developer. The drug is being studied for bacterial infections such as pneumonia, ventilator-associated pneumonia, and urinary tract infections.
Doripenem has completed four clinical trials. NCT00210938 and NCT00229060 were Phase 3 studies in complicated intra-abdominal infections with 478 and 483 patients, respectively. NCT00515034 was a Phase 2 safety study in abdominal infections or pneumonia with 146 patients. NCT01381848 was a Phase 1 study in infants with bacterial infections.
Doripenem is a carbapenem antibiotic, a class that includes drugs like meropenem and imipenem. It is being developed by Johnson & Johnson (JNJ) for bacterial infections. The drug is in Phase 1 development and is not yet approved. No alternative names for Doripenem have been reported.