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

Phase 1

Conditions: P. aeruginosa pneumonia
MedDRA version: 19.1 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-ES

Lead Sponsor: Aridis Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 108

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.
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

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 Child- Pugh 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.

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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