Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01799993 | Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia | PHASE3 | COMPLETED | 725 | — | — | Apr 13, 2013 | Apr 7, 2017 | Jul 23, 2018 | 65 | United States, Australia +10 |
The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.
| Arm | Type | Description |
|---|---|---|
| Amikacin inhale (BAY41-6551) | EXPERIMENTAL | Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10. |
| Placebo | PLACEBO_COMPARATOR | Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10. |
| Name | Type | Description |
|---|---|---|
| Amikacin Inhalation Solution (BAY41-6551) | DRUG | 400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical) |
| Aerosolized Placebo | DRUG | Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical) |
Inclusion Criteria: * Males and non-pregnant, non-lactating females, 18 years of age or older * Intubated and mechanically-ventilated * Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph * Presence of Gram-negative organism(s) by either Gram stain o...