Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Amikacin · 3 trials · 2 indications
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.
Maximum serum amikacin concentration observed from time 0 to 12 h
Time that Cmax occurred
Area under the serum amikacin concentration vs time curve from time 0 to 12 h
Amount of amikacin excreted in urine from 0 to 12 h after dosing
Amount of amikacin excreted in urine from 12 to 24 h after dosing
Amount of amikacin excreted in urine from 0 to 24 h after dosing
| 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. |
| Amikacin inhalation solution | EXPERIMENTAL | Subjects received 125 mg/mL of aerosolized amikacin via the PDDS clinical device at a nominal dose of 400 mg every 12 h for 7-14 days |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | PLACEBO_COMPARATOR | - |
| 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) |
| Amikacin (BAY41-6551) | DRUG | Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule |
| Placebo | DRUG | Two aerosol treatments per day (one treatment every 12hr) |
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...
Amikacin is an investigational small molecule being studied as an inhaled therapy for bacterial pneumonia, including nosocomial pneumonia in intubated, mechanically ventilated patients. It is delivered directly to the lungs as an aerosol. Amikacin is in clinical development and has not been approved for this use.
Amikacin is being developed by Nektar Therapeutics, a biopharmaceutical company traded on NASDAQ under the ticker NKTR. The company is conducting clinical trials of inhaled amikacin for the treatment of pneumonia.
Amikacin is in Phase 2 clinical development for pneumonia. Two Phase 2 trials have been completed, and a Phase 3 trial has also been completed. The drug remains investigational and is not approved by regulatory authorities.
Amikacin has been studied in three completed trials. NCT01004445 and NCT01021436 were Phase 2 studies of aerosolized amikacin in ventilated patients with pneumonia. NCT01799993 was a Phase 3 trial of inhaled amikacin solution as adjunctive therapy for Gram-negative pneumonia, enrolling 725 patients.
Amikacin is an aminoglycoside antibiotic that works by binding to the bacterial ribosome, interfering with protein synthesis and leading to bacterial cell death. It is being developed as an inhaled formulation to deliver high drug concentrations directly to the site of infection in the lungs.
Amikacin is also known as BAY41-6551 in clinical trials. The Phase 3 study NCT01799993 evaluated inhaled amikacin solution BAY41-6551 as adjunctive therapy in the treatment of Gram-negative pneumonia.