Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Active comparator
MEDI4893 · 2 trials · 2 indications
The EAC S aureus pneumonia was based on clinical, radiographic, and microbiologic criteria. Clinical criteria: 1 major criteria (PaO2/FiO2 ratio \< 240 mmHg maintained for at least 4 hours or decrease in PaO2/FiO2 by \>= 50 mmHg maintained for at least 4 hrs or a need to initiate non-invasive mechanical ventilation or re-initiate invasive mechanical ventilation because of respiratory failure or worsening of respiratory status); and at least 2 of minor criteria (systemic signs of infection, production of purulent sputum/endotracheal secretions, new onset of cough, physical examination findings consistent with pneumonia/pulmonary consolidation, dyspnea, and/or tachypnea). Radiographic criteria: new or worsening infiltrate consistent with pneumonia on chest X-ray obtained within 24 hrs of event. Microbiologic criteria: at least 1 culture positive for S aureus (respiratory specimen, or blood, or pleural fluid aspirate or lung tissue culture during episode of pneumonia).
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
An AESI is one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. An AESI may have been serious or non-serious.
An NOCD defined as a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving the study drug and is assessed by the investigator as medically significant.
blood pressure, heart rate, respiratory rate, temperature
Chemistry, Hematology and urinalysis
| Arm | Type | Description |
|---|---|---|
| MEDI4893 5000 mg | ACTIVE_COMPARATOR | Participants will receive a single intravenous (IV) dose of MEDI4893 5000 milligrams (mg) on Day 1 of the study. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study. |
| MEDI4893 2000 mg | ACTIVE_COMPARATOR | Participants will receive a single IV dose of MEDI4893 2000 mg on Day 1 of the study. |
| MEDI4893 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MEDI4893 | DRUG | Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study. |
| Placebo | OTHER | Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study. |
Inclusion Criteria: * Colonized with Staphylococcus aureus, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. Exclusion Criteria: * Staphylococcal disease at randomisation; lung injury score consistent with pneumonia; current lung disea...
MEDI4893 is an investigational drug being studied for the prevention of Staphylococcus aureus pneumonia and infections caused by Staphylococcus aureus. It is being developed by AstraZeneca PLC (AZN) as a potential treatment for these infectious disease conditions.
MEDI4893 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in clinical development for infectious disease indications.
MEDI4893 has completed a Phase 1 trial and a Phase 2 trial. The Phase 1 study evaluated safety, tolerability, and pharmacokinetics in healthy adults, while the Phase 2 study assessed efficacy and safety in patients with Staphylococcus aureus pneumonia.
MEDI4893 has been studied in two completed clinical trials. NCT01769417 was a Phase 1 study in healthy adults in the United States, and NCT02296320 was a Phase 2 study in patients with Staphylococcus aureus pneumonia across multiple countries including the United States and several European nations.
MEDI4893 is not FDA approved. It is an investigational drug that has completed clinical trials but remains in development. The completed trials include a Phase 1 study and a Phase 2 study, but no approval status has been established.