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Clinical Trials List

Protocol NumberAR-105-002
NCT Number(ClinicalTrials.gov Identfier)NCT03027609

2017-06-01 - 2019-12-31

Phase II

Terminated10

ICD-10J15.1

Pneumonia due to Pseudomonas

ICD-10J13

Pneumonia due to Streptococcus pneumoniae

Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia

  • Trial Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

    Aridis Pharmaceuticals, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 鄭高珍 Division of General Internal Medicine
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ming -Cheng Chan Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator KUANG-YAO YANG Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator 彭萬誠 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yu-Chao Lin Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 郭立國 Division of General Internal Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳垚生 Division of Infectious Disease
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chau-Chyun Sheu 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

None

Principal Investigator Chong-Jen Yu Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 郭立國 Division of General Internal Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Pseudomonas Aeruginosa Pneumonia

Objectives

Primary Clinical Efficacy Objective To assess the efficacy of Aerucin®, administered as a single dose in addition to standard antibiotic regimen, in terms of clinical cure, as assessed by an adjudication committee, at day 14, i.e., resolution of the P. aeruginosa pneumonia event diagnosed at enrollment, as compared to standard antibiotic therapy alone. Primary Clinical Safety Objective To assess the clinical safety and tolerability of Aerucin® in the study population.

Test Drug

Aerucin（aerubumab，AR-105）

Active Ingredient

Aerucin

Dosage Form

injection

Dosage

27.5 mg/mL

Endpoints

Primary Clinical Efficacy Parameter
Clinical cure, i.e., resolution of the pneumonia event diagnosed at enrollment. “Clinical cure” is
resolution of pneumonia as determined by an independent adjudication committee based on
objective criteria. Clinical cure at day 14 will be used as primary clinical efficacy parameter.
Secondary Clinical Efficacy Parameters
1. Clinical cure:
- Clinical cure rate at day 4, 7, 21 and 28.
- Time to clinical cure.
2. Mortality:
- All-cause mortality
- Pneumonia-related mortality
- Time to death over the 28-day follow-up period.
3. Respiratory function assessment: PaO2/FiO2
4. Overall clinical status: SOFA
5. Health economics and well-being: antibiotic utilization, duration of stay in the ICU,
duration of hospitalization, ventilator-free days.
Microbiological Endpoints
1. Microbiological outcome of the index P. aeruginosa pneumonia as assessed by the local
laboratory and confirmed by the central laboratory.
2. Change in bacterial load related to the index P. aeruginosa as assessed by the local
microbiological laboratory.
Pharmacokinetic assessment
Full PK sub-study involving 16 subjects
Sparse PK sub-study involving all remaining subjects

Inclution Criteria

Inclusion Criteria
1. Written Informed Consent given by the patient or, if not possible, by a legally authorized
representative and/or an independent physician as authorized by the competent ethics
committee (EC) or independent review board (IRB) and local regulations.
2. Diagnosis of pneumonia based on the following criteria:
a. A sequence of at least 2 chest X-rays showing the presence of new or progressive
infiltrate(s) suggestive of bacterial pneumonia or 1 definitive chest X-ray diagnostic of
pneumonia
b. Hypoxemia based on at least one of the following criteria:
i. PaO2/FiO2 <250
ii. PaO2 <60 mmHg
c. 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.
3. To be at least 18 years of age.
Taiwan only: To be at least 20 years of age
4. To be treated in an ICU at the time of enrollment.
5. Endotracheal tube in place (tracheostomy is allowed),
6. The patient is mechanically ventilated.
7. Documented pulmonary infection with P. aeruginosa obtained by BAL, mini-BAL,
protected endotracheal tube aspiration (ETA). For the purpose of randomization, P.
aeruginosa must be identified either by:
a. On the basis of available results from a culture positive by any method for P. aeruginosa
of a sample obtained less than 72 hours prior to randomization. In such case, a fresh
sample must be obtained prior to treatment initiation for standard microbial culture by the local laboratory (including organism identification, quantitative culture and
susceptibility testing); the corresponding culture results are not required prior to
randomization.
OR
b. On the basis of a rapid diagnostic test (see section 14.3 for allowed methods). In such
case, the same sample must be used for standard microbial culture by the local laboratory
(including organism identification, quantitative culture and susceptibility testing). The
corresponding culture results are not required prior to randomization.
8. APACHE II score ≥ 10 and ≤ 35 within 24 hours of enrollment.

Exclusion Criteria

Exclusion Criteria
1. The subject is moribund.
2. Effective antibacterial drug therapy for the index pneumonia administered continuously for
48 hours or more prior to initiation of study treatment.
3. Plasmapheresis (ongoing or planned)
4. Immunocompromised and at risk of infection by opportunistic pathogens including, but not
limited to the following:
a. HIV / AIDS who are not stable under medication and/or most recent CD4 <200
b. Expected neutropenia due to chemotherapy
c. Absolute neutrophil count less than 500/µL (mm3
)
d. Heart or lung transplant recipient within the past 6 months
5. Known hereditary complement deficiency.
6. Liver function deficiency associated with chronic conditions (e.g., liver cirrhosis ChildPugh C).
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. Administration of anti-infective monoclonal antibody within 3 months prior to enrollment.
9. Women of childbearing potential who are sexually active and have not been using a
medically acceptable method contraception for at least 12 months and in whom a pregnancy
test is either not available or positive at the time of enrollment. Women who are surgically
sterile or sterile for any other reason are eligible provided medical evidence is provided and
maintained in the study file. Women who are post-menopausal as evidenced by the absence
of menstruation for at least 1 year are eligible; the date of the last menstruation is to be
recorded in the study file unless postmenopausal status is obvious due to age.
10. Known lack of treatment compliance from prior studies or ongoing medical care based on
medical records and Principal Investigator’s judgment and/or the capacity of the patient to
comply with all study requirements.
11. 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.
12. Participation as 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. Patients who participate in observational or
epidemiological studies are eligible provided this does not interfere with their capacity or the
capacity of the study staff to comply with all study requirements.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    154 participants

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