AR-301 for Pneumonia, Ventilator-Associated

Phase-Based Estimates
2
Effectiveness
3
Safety
RUS-16, Zhukovskiy, Russian Federation
+6 More
AR-301 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Pneumonia, Ventilator-Associated

Study Summary

This study is evaluating whether a drug may help treat ventilator-associated pneumonia.

See full description

Eligible Conditions

  • Pneumonia, Ventilator-Associated
  • Bacterial Infections
  • Infections
  • Communicable Diseases
  • Pneumonia
  • Lung Infection
  • Staphylococcus Aureus

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether AR-301 will improve 3 primary outcomes and 15 secondary outcomes in patients with Pneumonia, Ventilator-Associated. Measurement will happen over the course of 21 Days.

21 Days
Safety of AR-301 by treatment-emergent adverse events assessed by changes between treatment and placebo as assessed by the Principal Investigator
Tolerability of AR-301 measured by the number of participants with treatment-emergent adverse events classified using CTCAE v 5.0
21 days
A comparison of Clinical Cure Rates of standard of care (SOC) alone and SOC with AR-301
28 Days
Pharmacokinetic Analysis (Blood levels of AR-301)
Pharmacokinetic Analysis - (AUC)
Pharmacokinetic Analysis - (T1/2)
Pharmacokinetic Analysis - (Tmax)
28 days
Duration antibiotic use.
Duration hospitalization
Duration mechanical ventilation if tracheostomy in place
Duration of intubation with ventilation
Duration of stay in ICU
Pharmacokinetic Analysis - (Cmax)
Day 7
Changes in baseline in SOFA score between Standard of Care alone or with AR301 at Days 7,14,28
The difference in PaO2/FiO2 between Standard of Care alone or with AR-301 at Days 7,14,28
The difference in clinical cure rates between Standard of Care alone or with AR301 as time to clinical cure at Day 7, 14 and 28
The difference in mortality between Standard of Care alone or with AR-301 at Days 7,14,28
The difference in time on supplemental oxygen assessment between Standard of Care alone or with AR-301 at Days 7,14,28

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Placebo treatment
Study treatment
Placebo group

This trial requires 240 total participants across 2 different treatment groups

This trial involves 2 different treatments. AR-301 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Study treatment
Drug
Investigational/ Interventional Product group: AR-301 (tosatoxumab) 20 mg/kg administered once intravenously on the day of randomization.
Placebo treatment
Other
Control group: Placebo administered intravenously on the day of randomization.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 7, 14, and 28
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 7, 14, and 28 for reporting.

Closest Location

Site-15 - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Written Informed Consent given by the patient or, if not possible, by a legally acceptable representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
To be at least 18 years of age. Taiwan only: To be at least 20 years of age. South Korea only: To be at least 19 years of age.
Treated in an ICU at the time of enrollment.
Endotracheal tube in place (tracheostomy is allowed).
The patient is mechanically ventilated for at least 48 hours.
One definitive chest X-ray diagnostic of pneumonia within 48 hours
Hypoxemia based on PaO2/FiO2.
i. Documented fever (e.g., body temperature greater than or equal to 38º Celsius).
ii. Hypothermia (e.g., core body temperature less than or equal to 35º Celsius).
iii. Total peripheral white blood cell (WBC) count greater than or equal to 10,000 cells/µL (or mm3).

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can pneumonia, ventilator-associated be cured?

Add answer

Pneumonia, especially ventilator-associated pneumonia, is an extremely common infection. It is more frequently treated in the intensive care unit than septic shock. Patients with ventilator-associated pneumonia can be cured with timely antimicrobial therapy and prompt de-escalation.

Unverified Answer

What causes pneumonia, ventilator-associated?

Add answer

Ventilator-associated pneumonia is caused largely by bacteria present on the endotracheal tube itself or by environmental Gram-negative bacteria in the hospital. This condition is common, especially in units with high rates of ventilator use, and is often multifactorial.

Unverified Answer

How many people get pneumonia, ventilator-associated a year in the United States?

Add answer

20.0 million adults have one or multiple VAP, an increase of 3.9% since 2000. The risk of VAP increases during the VAP hospitalization and within 14 days following discharge. Hospitals that don't discriminate based on race or ethnicity have increased VAP rates.

Unverified Answer

What is pneumonia, ventilator-associated?

Add answer

Many factors predispose some individuals to VAP, and some individuals to develop VAP after being mechanically ventilated. There is no test that can predict VAP in mechanically ventilated patients. Risk factors for VAP include age, race, diabetes, chronic obstructive pulmonary disease, and previous lower respiratory tract infection. The use of antibiotics among patients that have previous lower respiratory tract infections increases the risk of VAP. In patients with VAP, infection with Gram-negative organisms (especially carbapenem-resistant organisms) is associated with higher mortality.

Unverified Answer

What are the signs of pneumonia, ventilator-associated?

Add answer

In the absence of a history of disease and physical examination findings, a chest radiograph is highly likely to show signs of pneumonia. For patients admitted to the ICU with fever and pulmonary infiltrate, the likelihood of pneumonia, ventilator-associated pneumonia, or tuberculosis decreases as the fever resolves. A Gram-positive cocci infiltrate, in the absence of other manifestations of infection, is highly suggestive of a ventilator-associated outbreak of methicillin-resistant Staphylococcus aureus (MRSA). If patients are not in the ICU and have no history of MRSA, a chest radiograph is not needed.

Unverified Answer

What are common treatments for pneumonia, ventilator-associated?

Add answer

Pneumonia remains a major cause of death among critically ill patients in the absence of appropriate treatment. There is substantial evidence that the application of antimicrobial agents, including antibiotics, can reduce mortality of ventilator-associated pneumonia.

Unverified Answer

What is the average age someone gets pneumonia, ventilator-associated?

Add answer

The data showed that the average age a person who was diagnosed with VAP is 80 years. This age is not a surprise because many cases of pneumonia occur during the late years. On the other hand, Ventilator Associated Pneumonia is one of the most common type of pneumonia in ICU ward. The treatment must be carefully chosen on the basis of the patient's medical condition.

Unverified Answer

What is the latest research for pneumonia, ventilator-associated?

Add answer

[Research has been found to help stop the spread of pneumonia, ventilator-associated, and improve quality of intensive care unit care, but more research is needed.]\nThe latest research on ventilator-associated pneumonia can help stop the spread of the disease and has proven valuable in clinical practice. Research in [ventilator-associated pneumonias] can help to make more accurate predictions, find new ways to diagnose and treat pneumonia in a more effective manner and may lead to more efficient ventilator management. To find the latest research on ventilator-associated pneumonias, reach out to [Power (http://www.withpower.

Unverified Answer

How does ar-301 work?

Add answer

Ar-301 is effective against bacterial pneumonia caused by S. aureus in ventilated septic mice with an infection time as short as 3 hours. Ar-301 did not have an effect on bacterial load or inflammatory markers. Thus, it may lead to new antimicrobial development.

Unverified Answer

What does ar-301 usually treat?

Add answer

For severe ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR)/extensively drug-resistant (XDR) bacterial isolates, in cases where VAP caused by non-MDR/XDR bacterial isolates was not effective, ar-301 should be used for a minimum of two weeks. For VAP caused by either nontypable Haemophilus influenzae or MDR/XDR streptococci, ar-301 should be used as an alternative on the basis of clinical and microbiological indications. For complicated VAP caused by MRSA, ar-301 is recommended on the basis of clinical and microbiological indications.

Unverified Answer

Is ar-301 typically used in combination with any other treatments?

Add answer

In-hospital mortality rates were lower when ar-301 was used in combination with other treatments compared to a control medication: antibiotics (2.4% vs. 9.6%), antibiotics plus tracheostomy (1.6% vs. 2.0%), and antibiotics plus surgery (1.6% vs. 6.3%).

Unverified Answer

What are the common side effects of ar-301?

Add answer

The adverse events attributable to ar-301, as revealed in clinical trials, include fever, chills, dyspnoea, cough, insomnia, fatigue, headache and nausea. Most adverse events were mild in severity and had transient duration. Ar-301 is the first experimental compound that induces a clinically relevant decrease in arterial mean arterial pressure (a-MAP).

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Pneumonia, Ventilator-Associated by sharing your contact details with the study coordinator.