Clinical trial NCT05331885: A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ventilator Associated Pneumonia
Staphylococcus Aureus
Lead sponsor: Aridis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase 3, randomized, placebo-controlled, single-dose study.
Primary purpose: TREATMENT

Brief summary: Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

Detailed description: This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy of a single IV dose of suvratoxumab in mechanically ventilated subjects in the ICU who are at high risk for S. aureus infections and who are currently free of active S. aureus-related disease but are colonized with S. aureus in the LRT.

Eligibility criteria: Inclusion Criteria:

1. Colonized with Staphylococcus aureus;
2. Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

Exclusion Criteria:

1. Staphylococcal disease at randomisation;
2. Lung injury score consistent with pneumonia;
3. Chronic tracheostomy patients;
4. The study subject is moribund
5. Receipt of anti- S. aureus systemic antibiotics
6. Active pulmonary disease

Primary outcomes:
measure: Incidence of nosocomial all-cause pneumonia through 30 days post dose
timeFrame: 30 days
Secondary outcomes:
measure: Number of participants with TEAE at 30 days
timeFrame: 30 days
measure: Number of participants with TESAE at 90 days
timeFrame: 90 days
measure: Number of participants with TEAESI at 90 days
timeFrame: 90 days
measure: Number of Participants with Nosocomial all-cause pneumonia or death through 30 days post dose
timeFrame: 30 days
measure: Number of Participants with Nosocomial S. aureus pneumonia through 30 days post dose
timeFrame: 30 days
measure: Number of Participants with Nosocomial S. aureus pneumonia through 90 days post dose
timeFrame: 90 days
measure: Suvratoxumab Maximum Observed Serum Concentration (Cmax)
timeFrame: 90 days
measure: Suvratoxumab Area under the Plasma Concentration-Time Curve (AUC)
timeFrame: 90 days
measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Suvratoxumab
timeFrame: 90 days
Other outcomes:
Locations:
city: Haine-Saint-Paul
country: Belgium
facility: Research Site Bel03
city: Ottignies
country: Belgium
facility: Research Site Bel02
city: Yvoir
country: Belgium
facility: Research Site Bel05
city: Argenteuil
country: France
facility: Research Site Fra05
city: La Roche-sur-Yon
country: France
facility: Research Site Fra16
city: Le Mans
country: France
facility: Research Site Fra10
city: Lille
country: France
facility: Research Site Fra08
city: Limoges
country: France
facility: Fra06
city: Orléans
country: France
facility: Research Site Fra07
city: Pierre-Bénite
country: France
facility: Research Site Fra15
city: Tours
country: France
facility: Research Site Fra12
city: Trévenans
country: France
facility: Research Site Fra03
city: Larissa
country: Greece
facility: Research Site GRC01
city: Haifa
country: Israel
facility: Research Site ISR03
city: H̱olon
country: Israel
facility: Research Site ISR05
city: Ramat Gan
country: Israel
facility: Research Site ISR01
city: Tsefat
country: Israel
facility: Research Site ISR06
city: Enschede
country: Netherlands
facility: Research Site NLD01
city: Heerlen
country: Netherlands
facility: Research Site NLD03
city: Utrecht
country: Netherlands
facility: Research Site NLD02
city: Barcelona
country: Spain
facility: Research Site SPA04
city: Córdoba
country: Spain
facility: Research Site SPA01
city: Madrid
country: Spain
facility: Research Site SPA07
city: Santander
country: Spain
facility: Research Site SPA08
city: Santiago De Compostela
country: Spain
facility: Research Site SPA06
city: Terrassa
country: Spain
facility: Research Site SPA03
city: Valence
country: Spain
facility: Research Site SPA05
Study officials:
affiliation: Centre Hospitalier Universitaire (CHU) de Limoges
name: Francois, MD
role: PRINCIPAL_INVESTIGATOR
References: