A Phase 3 interventional study of AR-301 and Placebo in Lung Infection, Pneumonia, Ventilator-Associated and Infection, Bacterial, sponsored by Aridis Pharmaceuticals, Inc.. Completed at 45 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Aridis Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
AR-301 is being evaluated as an adjunctive treatment of ventilator-associated pneumonia (VAP) due to Staphylococcus aureus (S. aureus) in combination with standard of care (SOC) antibiotic therapy in patients with confirmed S. aureus infection.
This study is an international, multicenter, prospective, randomized, double blind, placebo controlled, parallel design protocol in patients with Ventilator-Associated Pneumonia (VAP) caused by S. aureus.
Patients with a documented diagnosis of pneumonia due to S. aureus, and require ICU care, who have been intubated (or have a tracheostomy tube in place) and mechanically ventilated for at least 48 hours are eligible for screening.
In total, approximately 240 subjects will be randomized 1-1 to be treated with placebo plus standard of care (SOC) or AR-301 (20 mg/kg) plus SOC in this Phase 3 study.
Study subjects will receive a single dose at Day 0 in addition to SOC antibiotic treatment, and then enter a safety, efficacy and PK study period for a total study duration of 28 days. The selection of SOC antibiotics is made in accordance with local best practices at the discretion of the investigator.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 174 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Aridis Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of pneumonia based on the following criteria (a, b, and c, all must be met):
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).
iv. Leukopenia with total WBC less than or equal to 4,500 cells/µL (mm3). v. Greater than 15 percent immature neutrophils (bands) noted on peripheral blood smear.
Exclusion Criteria
Investigational/ Interventional Product group: AR-301 (tosatoxumab) 20 mg/kg administered once intravenously on the day of randomization.
Drug: AR-301
Control group: Placebo administered intravenously on the day of randomization.
Other: Placebo
AR-301 (tosatoxumab) 20 mg/kg administered once intravenously the day of enrolment.
Also known as: AR-301 (tosatoxumab)
Placebo comparator
A comparison of Clinical Cure Rates of standard of care (SOC) alone and SOC with AR-301
Clinical cure rates of standard of care (SOC) alone and (SOC) with AR-301 at Day 21 as measured by all-cause mortality, need for mechanical ventilation and signs and symptoms of pneumonia.
Time frame: 21 days
Safety of AR-301 by treatment-emergent adverse events assessed by changes between treatment and placebo as assessed by the Principal Investigator
Safety of AR-301 of treatment-emergent adverse events as assessed by changes assessed by the PI between treatment and placebo
Time frame: 21 Days
Tolerability of AR-301 measured by the number of participants with treatment-emergent adverse events classified using CTCAE v 5.0
Tolerability of AR-301 will be measured and evaluated by the severity of treatment-emergent adverse events using the CTCAE v 5.0.
Time frame: 21 Days
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
Difference in Clinical Cure rates between SOC alone or with AR-301 defined by time to clinical cure (number of days) using the same criteria as for the primary efficacy objective at Day 21.
Time frame: Day 7, 14, and 28
The difference in mortality between Standard of Care alone or with AR-301 at Days 7,14,28
Difference in mortality defined as cause of death (all-cause mortality and pneumonia-related mortality)between SOC alone or with AR-301 at Days 7,14, and 28
Time frame: Day 7, 14, and 28
The difference in PaO2/FiO2 between Standard of Care alone or with AR-301 at Days 7,14,28
Difference in respiratory function between SOC alone or with AR-301 at Days 7,14, and 28 as changes in PaO2/FiO2 ratio (e.g. by arterial blood gases), if available and whenever possible OR changes in non-invasive measures of oxygenation (e.g. by pulse oximetry)
Time frame: Day 7, 14, and 28
The difference in time on supplemental oxygen assessment between Standard of Care alone or with AR-301 at Days 7,14,28
Difference in respiratory function between SOC alone or with AR-301 at Days 7,14, and 28 as time on supplemental oxygen
Time frame: Day 7, 14, and 28
Changes in baseline in SOFA score between Standard of Care alone or with AR301 at Days 7,14,28
Difference in Clinical Cure rates between SOC alone or with AR-301 at Days 7,14, and 28 in the following clinical outcomes: Changes from Baseline in sequential organ failure assessment (SOFA) score using the following scale: Maximum SOFA score 0-6, \<10% Mortality, 7-9 15-20% mortality, 10-12 40-50% mortality, 13-14 50-60% mortality, 15 \>80% mortality, 15-24 \>90% mortality. Lower numbers are considered to be better outcome of mortality and higher scores worse outcome of mortality.
Time frame: Day 7, 14, and 28
Duration of intubation with ventilation
Number of days with intubation with ventilation
Time frame: 28 days
Duration mechanical ventilation if tracheostomy in place
Number of days of intubation with mechanical ventilation if tracheostomy in place
Time frame: 28 days
Duration of stay in ICU
Number of days of stay in ICU
Time frame: 28 days
Duration hospitalization
Number of days of hospitalization
Time frame: 28 days
Duration antibiotic use.
Number of days on antibiotics
Time frame: 28 days
Pharmacokinetic Analysis - (Cmax)
Pharmacokinetic analysis measuring Maximum Serum Concentration (Cmax)
Time frame: 28 days
Pharmacokinetic Analysis - (AUC)
Pharmacokinetic analysis measuring Area Under the Curve (AUC)
Time frame: 28 Days
Pharmacokinetic Analysis - (T1/2)
Pharmacokinetic analysis measuring time for half of the initial dose of study drug to be eliminated from the body (T1/2)
Time frame: 28 Days
Pharmacokinetic Analysis - (Tmax)
Pharmacokinetic analysis measuring time at which Cmax is obtained (Tmax)
Time frame: 28 Days
Pharmacokinetic Analysis (Blood levels of AR-301)
Blood levels of AR-301 in the patient over time during the study period.
Time frame: 28 Days
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Aridis Pharmaceuticals, Inc.