Placebo-controlled, double-blind, randomized study of Aerucin® as adjunct therapy to antibiotics in the treatment of P. aeruginosa pneumonia

Phase 1

Conditions: Pseudomonas aeruginosa pneumonia
MedDRA version: 20.0 Level: PT Classification code 10035664 Term: Pneumonia System Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2016-004261-10-GR

Lead Sponsor: Aridis Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 154

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. 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. To be treated in an ICU at the time of enrollment.
4. Endotracheal tube in place (tracheostomy is allowed).
5. The patient is mechanically ventilated.
6. Diagnosis of pneumonia based on the following criteria (a, b, and c, all
must be met):
a. One definitive chest X-ray diagnostic of pneumonia, or
A sequence of at least 2 chest X-rays showing the presence of new or
progressive infiltrate(s) suggestive of bacterial pneumonia.
b. Hypoxemia based on at least one of the following
measurements/criteria:
i. PaO2/FiO2 <250 mmHg (at sea level or equivalent for significant
elevations above sea level) while intubated and mechanically ventilated,
as one or more measures within or
ii. PaO2 <60 mmHg (at sea level or equivalent for significant elevations
above sea level) while intubated and mechanically ventilated, as one or
more measures within or
iii. Respiratory failure necessitating intubation and mechanical
ventilation. If tracheostomy is in place, the need for mechanical
ventilation.
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.
7. Documented pulmonary infection with P. aeruginosa obtained by BAL,
mini-BAL, protected endotracheal tube aspiration (ETA) (collectively
'airway specimen'). For the study randomization, P. aeruginosa must be
identified by one of the three methods below:
a. An airway specimen culture positive by any method for P. aeruginosa
of a specimen obtained less than 72 hours prior to randomization. A
fresh airway specimen must be obtained prior to treatment initiation for
baseline standard microbial culture by the local laboratory (including
organism identification, quantitative/semi-quantitative culture and
susceptibility testing); the corresponding culture results are NOT
required prior to randomization.
OR
b. A rapid diagnostic test. In such ca

Exclusion Criteria

1. The subject is moribund. Clinical judgment by the investigator that the
subject is unlikely to survive the current illness/ICUadmission/treatment period despite delivery of adequate antibiotics for
treatment of P. aeruginosa 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 P. aeruginosa.
3. Plasmapheresis (ongoing or planned) or any procedure that would
remove/filter out the monoclonal antibody/study drug.
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 dysfunction with a Child Pugh C score (Child Pugh score of A or B
are acceptable at discretion of the 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 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. Non-pregnant and
non-lactating with confirmation via local laboratory testing is required.
Women who are post-menopausal as evidenced by the absence of
menstruation for at least 1 year are eligible; the date of last
menstruation is to be recorded in the study files unless post-menopausal
status is obvious due to age.
10. Any sexually active subject who is unwilling to use acceptable
methods of contraception for 120 days after dosing. WOCBP must agree
to use to an effective method of birth control (e.g., prescription oral
contraceptives, contraceptive injections, contraceptive patch,
intrauterine device, barrier methods, abstinence) or male partner
sterilization alone for the duration of the study and for at least 120 days
after dosing. Males with female partners of reproductive potential must
agree to practice abstinence or to use a condom (male) plus an
additional barrier method (female partner) of contraception for the
duration of the study and for at least 120 days after dosing.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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