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Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301 (AR-301-002)

Primary Purpose

Lung Infection, Pneumonia, Ventilator-Associated, Infection, Bacterial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AR-301
Placebo
Sponsored by
Aridis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Infection focused on measuring Staphylococcus aureus, S. aureus, monoclonal antibody, Aridis, VAP, ventilator acquired pneumonia, infection, pneumonia, AR301

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Treated in an ICU at the time of enrollment.
  4. Endotracheal tube in place (tracheostomy is allowed).
  5. The patient is mechanically ventilated for at least 48 hours.
  6. Diagnosis of pneumonia based on the following criteria (a, b, and c, all must be met):

    1. One definitive chest X-ray diagnostic of pneumonia within 48 hours,
    2. Hypoxemia based on PaO2/FiO2.
    3. At least one of the following signs:

    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.

  7. Documented pulmonary infection with Staphylococcus aureus obtained by bronchoalveolar lavage (BAL), mini-BAL, protected endotracheal aspiration/aspirate (ETA) (collectively 'airway specimen').

Exclusion Criteria

  1. The subject is unlikely to survive for the study duration despite delivery of adequate antibiotics and supportive care for treatment of S. aureus pneumonia.
  2. Effective antibacterial drug therapy for the index pneumonia administered continuously for 48 hours or more prior to initiation of study treatment. Effective antibiotics would include those typically used to treat S. aureus.
  3. Plasmapheresis (ongoing or planned), extracorporeal membrane oxygenation (ECMO) or any procedure that would remove/filter out the monoclonal antibody/study drug.
  4. Immunocompromised patients.
  5. Known hereditary complement deficiency.
  6. Liver dysfunction with a Child Pugh C score > 9 (Child Pugh score of A or B are acceptable at discretion of the Principal Investigator [PI]).
  7. Pulmonary disease that precludes evaluation of a therapeutic response (such as lung cancer resulting in bronchial obstruction or on the same side as the pneumonia, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection, lung abscess, pleural empyema or post obstructive pneumonia).
  8. Patient has received intravenous (IV) immunoglobulin therapy within 3 months prior to the Screening Visit.
  9. Any woman of child-bearing potential (WOCBP) who does not have a negative pregnancy test result at Screening using SERUM or URINE testing based on Beta-subunit human chorionic gonadotropin (HCG) standard tests and methods from the local laboratory.
  10. Any sexually active subject who is unwilling to use acceptable methods of contraception for 120 days after dosing.
  11. Known lack of treatment compliance from prior studies or ongoing medical care based on medical records and PI's judgment and/or the capacity of the patient to comply with all study requirements.
  12. Any medical, psychological, cognitive, social or legal conditions that would interfere in the ability to give an Informed Consent OR the absence of a legally valid representative of the patient or independent physician allowed and able to give consent on his/her behalf.
  13. Participation as a subject in another interventional study within 30 days prior to the first dose of study treatment, or planned participation in such a study during the study or within 30 days of its completion by the patient.

Sites / Locations

  • BLR-04
  • BLR-06
  • BLR-01
  • BEL-01
  • BEL-05
  • BRA-08
  • BRA-04
  • CHN-09
  • EST-01
  • FRA-02
  • FRA-18
  • FRA-10
  • FRA-05
  • FRA-04
  • FRA-01
  • FRA-16
  • FRA-11
  • FRA-13
  • GEO-06
  • GEO-01
  • GEO-03
  • GEO-04
  • GEO-10
  • GEO-02
  • GEO-09
  • GEO-07
  • ISR-04
  • ISR-01
  • LVA-02
  • MEX-07
  • RUS-18
  • RUS-11
  • RUS-01
  • RUS-04
  • RUS-02
  • RUS-10
  • RUS-16
  • ZAF-09
  • ESP-01
  • TUR-06
  • TUR-01
  • UKR-05
  • UKR-03
  • UKR-02
  • UKR-09

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study treatment

Placebo treatment

Arm Description

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

Control group: Placebo administered intravenously on the day of randomization.

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

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.
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
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)
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
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.
Duration of intubation with ventilation
Number of days with intubation with ventilation
Duration mechanical ventilation if tracheostomy in place
Number of days of intubation with mechanical ventilation if tracheostomy in place
Duration of stay in ICU
Number of days of stay in ICU
Duration hospitalization
Number of days of hospitalization
Duration antibiotic use.
Number of days on antibiotics
Pharmacokinetic Analysis - (Cmax)
Pharmacokinetic analysis measuring Maximum Serum Concentration (Cmax)
Pharmacokinetic Analysis - (AUC)
Pharmacokinetic analysis measuring Area Under the Curve (AUC)
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)
Pharmacokinetic Analysis - (Tmax)
Pharmacokinetic analysis measuring time at which Cmax is obtained (Tmax)
Pharmacokinetic Analysis (Blood levels of AR-301)
Blood levels of AR-301 in the patient over time during the study period.

Full Information

First Posted
December 21, 2018
Last Updated
July 4, 2023
Sponsor
Aridis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03816956
Brief Title
Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301
Acronym
AR-301-002
Official Title
A Randomized Double-blind Placebo-controlled Multicenter Phase 3 Study of Efficacy and Safety of AR-301 as Adjunct Therapy to Antibiotics in the Treatment of Ventilator-Associated Pneumonia (VAP) Caused by S. Aureus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2019 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aridis Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Infection, Pneumonia, Ventilator-Associated, Infection, Bacterial, Staphylococcus Aureus
Keywords
Staphylococcus aureus, S. aureus, monoclonal antibody, Aridis, VAP, ventilator acquired pneumonia, infection, pneumonia, AR301

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study treatment
Arm Type
Experimental
Arm Description
Investigational/ Interventional Product group: AR-301 (tosatoxumab) 20 mg/kg administered once intravenously on the day of randomization.
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
Control group: Placebo administered intravenously on the day of randomization.
Intervention Type
Drug
Intervention Name(s)
AR-301
Other Intervention Name(s)
AR-301 (tosatoxumab)
Intervention Description
AR-301 (tosatoxumab) 20 mg/kg administered once intravenously the day of enrolment.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
A comparison of Clinical Cure Rates of standard of care (SOC) alone and SOC with AR-301
Description
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
Title
Safety of AR-301 by treatment-emergent adverse events assessed by changes between treatment and placebo as assessed by the Principal Investigator
Description
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
Title
Tolerability of AR-301 measured by the number of participants with treatment-emergent adverse events classified using CTCAE v 5.0
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
The difference in mortality between Standard of Care alone or with AR-301 at Days 7,14,28
Description
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
Title
The difference in PaO2/FiO2 between Standard of Care alone or with AR-301 at Days 7,14,28
Description
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
Title
The difference in time on supplemental oxygen assessment between Standard of Care alone or with AR-301 at Days 7,14,28
Description
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
Title
Changes in baseline in SOFA score between Standard of Care alone or with AR301 at Days 7,14,28
Description
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
Title
Duration of intubation with ventilation
Description
Number of days with intubation with ventilation
Time Frame
28 days
Title
Duration mechanical ventilation if tracheostomy in place
Description
Number of days of intubation with mechanical ventilation if tracheostomy in place
Time Frame
28 days
Title
Duration of stay in ICU
Description
Number of days of stay in ICU
Time Frame
28 days
Title
Duration hospitalization
Description
Number of days of hospitalization
Time Frame
28 days
Title
Duration antibiotic use.
Description
Number of days on antibiotics
Time Frame
28 days
Title
Pharmacokinetic Analysis - (Cmax)
Description
Pharmacokinetic analysis measuring Maximum Serum Concentration (Cmax)
Time Frame
28 days
Title
Pharmacokinetic Analysis - (AUC)
Description
Pharmacokinetic analysis measuring Area Under the Curve (AUC)
Time Frame
28 Days
Title
Pharmacokinetic Analysis - (T1/2)
Description
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
Title
Pharmacokinetic Analysis - (Tmax)
Description
Pharmacokinetic analysis measuring time at which Cmax is obtained (Tmax)
Time Frame
28 Days
Title
Pharmacokinetic Analysis (Blood levels of AR-301)
Description
Blood levels of AR-301 in the patient over time during the study period.
Time Frame
28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Diagnosis of pneumonia based on the following criteria (a, b, and c, all must be met): One definitive chest X-ray diagnostic of pneumonia within 48 hours, Hypoxemia based on PaO2/FiO2. At least one of the following signs: 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. Documented pulmonary infection with Staphylococcus aureus obtained by bronchoalveolar lavage (BAL), mini-BAL, protected endotracheal aspiration/aspirate (ETA) (collectively 'airway specimen'). Exclusion Criteria The subject is unlikely to survive for the study duration despite delivery of adequate antibiotics and supportive care for treatment of S. aureus pneumonia. Effective antibacterial drug therapy for the index pneumonia administered continuously for 48 hours or more prior to initiation of study treatment. Effective antibiotics would include those typically used to treat S. aureus. Plasmapheresis (ongoing or planned), extracorporeal membrane oxygenation (ECMO) or any procedure that would remove/filter out the monoclonal antibody/study drug. Immunocompromised patients. Known hereditary complement deficiency. Liver dysfunction with a Child Pugh C score > 9 (Child Pugh score of A or B are acceptable at discretion of the Principal Investigator [PI]). Pulmonary disease that precludes evaluation of a therapeutic response (such as lung cancer resulting in bronchial obstruction or on the same side as the pneumonia, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection, lung abscess, pleural empyema or post obstructive pneumonia). Patient has received intravenous (IV) immunoglobulin therapy within 3 months prior to the Screening Visit. Any woman of child-bearing potential (WOCBP) who does not have a negative pregnancy test result at Screening using SERUM or URINE testing based on Beta-subunit human chorionic gonadotropin (HCG) standard tests and methods from the local laboratory. Any sexually active subject who is unwilling to use acceptable methods of contraception for 120 days after dosing. Known lack of treatment compliance from prior studies or ongoing medical care based on medical records and PI's judgment and/or the capacity of the patient to comply with all study requirements. Any medical, psychological, cognitive, social or legal conditions that would interfere in the ability to give an Informed Consent OR the absence of a legally valid representative of the patient or independent physician allowed and able to give consent on his/her behalf. Participation as a subject in another interventional study within 30 days prior to the first dose of study treatment, or planned participation in such a study during the study or within 30 days of its completion by the patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan S Jafri, MD, FAAP
Organizational Affiliation
Aridis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
BLR-04
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
BLR-06
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
BLR-01
City
Minsk
ZIP/Postal Code
223041
Country
Belarus
Facility Name
BEL-01
City
Lodelinsart
ZIP/Postal Code
6042
Country
Belgium
Facility Name
BEL-05
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
BRA-08
City
Curitiba
ZIP/Postal Code
80810-050
Country
Brazil
Facility Name
BRA-04
City
Curitiba
ZIP/Postal Code
82050-350
Country
Brazil
Facility Name
CHN-09
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
EST-01
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
FRA-02
City
Strasbourg
State/Province
Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
FRA-18
City
Brive-la-Gaillarde
ZIP/Postal Code
19312
Country
France
Facility Name
FRA-10
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
FRA-05
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
FRA-04
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
FRA-01
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
FRA-16
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
FRA-11
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
FRA-13
City
Trevenans
ZIP/Postal Code
90400
Country
France
Facility Name
GEO-06
City
Gori
ZIP/Postal Code
1400
Country
Georgia
Facility Name
GEO-01
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
GEO-03
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
GEO-04
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
GEO-10
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
GEO-02
City
Tbilisi
ZIP/Postal Code
0141
Country
Georgia
Facility Name
GEO-09
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
GEO-07
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
ISR-04
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
ISR-01
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
LVA-02
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
MEX-07
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
RUS-18
City
Arkhangelsk
ZIP/Postal Code
163002
Country
Russian Federation
Facility Name
RUS-11
City
Chelyabinsk
ZIP/Postal Code
454000
Country
Russian Federation
Facility Name
RUS-01
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
RUS-04
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
RUS-02
City
Saint Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
RUS-10
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
RUS-16
City
Zhukovskiy
ZIP/Postal Code
140180
Country
Russian Federation
Facility Name
ZAF-09
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
ESP-01
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
TUR-06
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
TUR-01
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
UKR-05
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
UKR-03
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
UKR-02
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
UKR-09
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.aridispharma.com/contact-us/
Description
Website of the Sponsor

Learn more about this trial

Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301

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