Ventilator Associated PneumoniaPhase 3SAATELLITE-2NCT05331885
A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
A Phase 3 study testing Suvratoxumab in people with Ventilator Associated Pneumonia and Staphylococcus Aureus, run by Aridis Pharmaceuticals, Inc. at 27 sites in 6 countries.
Trial summary
Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Ventilator Associated Pneumonia, Staphylococcus Aureus
- What is being tested?
- Suvratoxumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 2 Sep 2022to 8 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Colonized with Staphylococcus aureus;
- Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Who cannot join
- Staphylococcal disease at randomisation;
- Lung injury score consistent with pneumonia;
- Chronic tracheostomy patients;
- The study subject is moribund
- Receipt of anti- S. aureus systemic antibiotics
- Active pulmonary disease
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
France9 sites
Research Site Fra05
Argenteuil
Research Site Fra16
La Roche-sur-Yon
Research Site Fra10
Le Mans
Research Site Fra08
Lille
Fra06
Limoges, 87042
Research Site Fra07
Orléans
Research Site Fra15
Pierre-Bénite
Research Site Fra12
Tours
Research Site Fra03
Trévenans
Spain7 sites
Research Site SPA04
Barcelona
Research Site SPA01
Córdoba
Research Site SPA07
Madrid
Research Site SPA08
Santander
Research Site SPA06
Santiago de Compostela
Research Site SPA03
Terrassa
Research Site SPA05
Valencia
Israel4 sites
Research Site ISR03
Haifa
Research Site ISR05
Holon
Research Site ISR01
Ramat Gan
Research Site ISR06
Safed
Belgium3 sites
Research Site Bel03
Haine-Saint-Paul
Research Site Bel02
Ottignies
Research Site Bel05
Yvoir
Netherlands3 sites
Research Site NLD01
Enschede
Research Site NLD03
Heerlen
Research Site NLD02
Utrecht
About this study
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
Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
Read the 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.
- Being tested
- Suvratoxumab, Placebo
- Medical subject headings
- Pneumonia, Ventilator-Associated, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvratoxumabBiological
Also called AR-320, MEDI4893
Monoclonal antibody
PlaceboDrug
Placebo contains only excipients
| Study group | Role | What they receive |
|---|---|---|
| AR-320 (Suvratoxumab) | Experimental | Participants will receive a single intravenous (IV) dose of suvratoxumab on Day 0 of the study. Receives: Biological: Suvratoxumab |
| Placebo | Placebo comparator | Participants will receive a single IV dose of placebo to survatoxumab on Day 0 of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nosocomial all-cause pneumonia through 30 days post dose
All-cause pneumonia is based on clinical, radiographic, and microbiologic criteria. The percent reduction of the incidence of (% of patients with) nosocomial all-cause pneumonia, regardless of identified etiology, following administration of study drug through 30 days post dose
Measured: 30 days
Secondary outcomes (9)
Number of participants with TEAE at 30 days
Treatment emergent adverse events (TEAE) are those adverse events (AEs, any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship) that occur or worsen during the treatment period, i.e., after the administration of study drug, through 30 days post dose
Measured: 30 days
Number of participants with TESAE at 90 days
Treatment emergent serious adverse events (TESAE) are serious adverse events (SAEs, AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience; persistent or significant disability/incapacity; congenital anomaly) that, as TEAEs, are present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, through 90 days
Measured: 90 days
Number of participants with TEAESI at 90 days
A TEAE of special interest (TEAESI) is an AE of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. An AESI may have been serious or non-serious. The time-frame is 90 days.
Measured: 90 days
Number of Participants with Nosocomial all-cause pneumonia or death through 30 days post dose
All-cause pneumonia is based on clinical, radiographic, and microbiologic criteria. The percent reduction of the incidence of (% of patients with) nosocomial all-cause pneumonia, regardless of cause, or death following administration of study drug through 30 days post dose
Measured: 30 days
Number of Participants with Nosocomial S. aureus pneumonia through 30 days post dose
- aureus pneumonia is based on clinical, radiographic, and microbiologic criteria. The percent reduction of the incidence of (% of patients with) nosocomial S. aureus pneumonia following administration of study drug through 30 days post dose
Measured: 30 days
Number of Participants with Nosocomial S. aureus pneumonia through 90 days post dose
- aureus pneumonia is based on clinical, radiographic, and microbiologic criteria. The percent reduction of the incidence of (% of patients with) nosocomial S. aureus pneumonia following administration of study drug through 90 days post dose
Measured: 90 days
Suvratoxumab Maximum Observed Serum Concentration (Cmax)
Maximum Observed Serum Concentration (Cmax) of suvratoxumab at Day 0 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 7, 30 and 90. At Day 90 only for a subset of patients.
Measured: 90 days
Suvratoxumab Area under the Plasma Concentration-Time Curve (AUC)
the area under the plasma concentration-time curve (AUC) will be measured from time 0 to Day 30 (AUC0-30), in all study subjects, and AUC from time 0 to Day 90 (AUC0-90) for a subset of subjects
Measured: 90 days
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Suvratoxumab
The incidence of (number of patients with) positive anti-drug antibodies (ADA) titer to suvratoxumab will be assessed and summarized by number and percentage of subjects that are ADA positive at predose, Day 30 in all subjects and Day 90 in a subset of patients.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start2 Sep 2022
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Why it stopped: The study was terminated due to administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase 3, randomized, placebo-controlled, single-dose study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aridis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francois, MD, Principal investigator, Centre Hospitalier Universitaire (CHU) de Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331885
- Sponsor's protocol ID
- AR-320-003
- Other IDs
- SAATELLITE-2
- Acronym
- SAATELLITE-2
- Status last verified
- Jan 2025
- First submitted
- 1 Apr 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05331885
- Acronym / sponsor ID
- SAATELLITE-2 / AR-320-003
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to administrative reasons
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aridis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Phase 3, randomized, placebo-controlled, single-dose study.
| Arm | Type | Receives |
|---|---|---|
| AR-320 (Suvratoxumab) | Experimental | Biological: SuvratoxumabParticipants will receive a single intravenous (IV) dose of suvratoxumab on Day 0 of the study. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single IV dose of placebo to survatoxumab on Day 0 of the study. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Colonized with Staphylococcus aureus;
- Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Key exclusion criteria (6 listed)
- Staphylococcal disease at randomisation;
- Lung injury score consistent with pneumonia;
- Chronic tracheostomy patients;
- The study subject is moribund
- Receipt of anti- S. aureus systemic antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuvratoxumabAlso: AR-320, MEDI4893Monoclonal antibody | Biological | AR-320 (Suvratoxumab) |
| PlaceboPlacebo contains only excipients | Drug | Placebo |
Primary outcome
Incidence of nosocomial all-cause pneumonia through 30 days post dose
Time frame: 30 days
All-cause pneumonia is based on clinical, radiographic, and microbiologic criteria. The percent reduction of the incidence of (% of patients with) nosocomial all-cause pneumonia, regardless of identified etiology, following administration of study drug through 30 days post dose
9 secondary outcomes
Number of participants with TEAE at 30 days
Time frame: 30 days
Number of participants with TESAE at 90 days
Time frame: 90 days
Number of participants with TEAESI at 90 days
Time frame: 90 days
Number of Participants with Nosocomial all-cause pneumonia or death through 30 days post dose
Time frame: 30 days
Number of Participants with Nosocomial S. aureus pneumonia through 30 days post dose
Time frame: 30 days
Number of Participants with Nosocomial S. aureus pneumonia through 90 days post dose
Time frame: 90 days
Suvratoxumab Maximum Observed Serum Concentration (Cmax)
Time frame: 90 days
Suvratoxumab Area under the Plasma Concentration-Time Curve (AUC)
Time frame: 90 days
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Suvratoxumab
Time frame: 90 days
Results and safety
The study was stopped early (reason given: The study was terminated due to administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois, MD principal investigator
Centre Hospitalier Universitaire (CHU) de Limoges
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suvratoxumab in people with Ventilator Associated Pneumonia and Staphylococcus Aureus, run by Aridis Pharmaceuticals, Inc. at 27 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Spain, Israel, Belgium, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to administrative reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nosocomial all-cause pneumonia through 30 days post dose (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.