A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

Phase 3

Conditions: Staphylococcus aureus
prevention of pneumonia
10004018

Registration Number: NL-OMON51453

Lead Sponsor: Aridis Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Adult (18 [unless otherwise specified by local Country laws] to 65 years of
age) or Adolescent (12 to < 18 years of age [unless otherwise specified by
local Country laws]) at the time of screening.
2. Written informed consent and written informed assent and any locally
required authorization (e.g., Health Insurance Portability and Accountability
Act [HIPPA] in the United States [US], European Union [EU] Data Privacy
Directive in the EU) obtained from the subject/legally acceptable
representative (LAR) prior to performing any protocol-related procedures,
including screening evaluations.
3. Females of childbearing potential (inclusive of adolescents) who are
sexually active with a non-sterilized male partner must have evidence of not
being pregnant upon enrolment and have a negative pregnancy test prior to
administration of investigational product.
- Females of childbearing potential are defined as those who are not surgically
sterile (i.e., bilateral oophorectomy, or complete hysterectomy), premenarchal
or postmenopausal (defined as 12 months with no menses without an alternative
medical cause).
4. Tracheal or bronchial sample positive by polymerase chain reaction (PCR) for
S. aureus within 36 hours prior to randomization. Note: the 36-hour window
will be determined by the time of sample collection.
5. Currently intubated and on mechanical ventilation in the ICU.
6. Expected to remain intubated and mechanically ventilated for * 3 days based
on investigator estimate.
7. No diagnosis of new-onset pneumonia within 72 hours prior to randomization
(subjects with evidence of resolved pneumonia will be eligible).

Exclusion Criteria

1. The study subject is moribund or unlikely to survive for a week post
randomization despite delivery of adequate antibiotics and supportive care
based on clinical judgement by the Principal Investigator (PI).
2. Acute confirmed or suspected active S. aureus disease at study enrolment and
investigational product dosing (colonization is acceptable as per inclusion
criterion #4).
3. Active pulmonary disease that would impair the ability to diagnose
pneumonia, such as active tuberculosis or fungal disease, obstructing lung
cancer, large empyema, cystic fibrosis, or acute respiratory distress syndrome
with lung white out.
4. Receipt of anti- S. aureus systemic antibiotics for > 48 hours within 72
hours prior to randomization that are considered active against the S. aureus
strain with which the subject is colonized or anticipated ongoing receipt of
anti- S. aureus systemic antibiotics.
5. Acute Physiology and Chronic Health Evaluation (APACHE)-II score >= 25 (if
Glasgow Coma Scale [GCS] score is > 5) or >= 30 (if GCS score is <= 5), or SOFA
score >= 9 at time of randomization.
- Note: Vasopressors only used to improve cerebral perfusion pressure (e.g.,
subarachnoid hemorrhage) will not be entered in the calculation of the
cardiovascular component of the SOFA score.
6. Receipt of any investigational drug therapy within 30 days prior to
randomization.
7. Previous receipt of a mAb within 60 days prior to randomization.
8. Subjects with a CD4 count of < 200 due to advanced human immunodeficiency
virus (HIV) infection. Subjects with a history of HIV infection who have been
on highly active antiretroviral therapy and asymptomatic from HIV infection for
at least 6 months may be enrolled.
9. History of allergic disease or reactions likely to be exacerbated by any
component of the investigational product.
10. Not able to complete long-term follow-up for at least 90 days post dose
based on investigator judgment.
11. Pregnant female or nursing mother.