Study of the Efficacy and Safety of MEDI4893

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects.

ClinicalTrials.gov ID

NCT02296320

Acronym / sponsor ID

SAATELLITE / CD-ID-MEDI4893-1139

Conditions

Staphylococcus Aureus Pneumonia

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

213 participants (actual)

Lead sponsor

MedImmune LLCIndustry (pharma, biotech, devices)

Collaborators

Innovative Medicines Initiative, Antibacterial Resistance Leadership Group, National Institute of Allergy and Infectious Diseases (NIAID)

Study start

10 Oct 2014 (actual)

Primary completion

2 Oct 2018 (actual)

Study completion

2 Oct 2018 (actual)

First posted

20 Nov 2014 (estimated)

Results

Posted 25 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

3

Who may qualify

Ages

18 to 130 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia

   Time frame: Day 1 through Day 31

   The EAC S aureus pneumonia was based on clinical, radiographic, and microbiologic criteria. Clinical criteria: 1 major criteria (PaO2/FiO2 ratio < 240 mmHg maintained for at least 4 hours or decrease in PaO2/FiO2 by >= 50 mmHg maintained for at least 4 hrs or a need to initiate non-invasive mechanical ventilation or re-initiate invasive mechanical ventilation because of respiratory failure or worsening of respiratory status); and at least 2 of minor criteria (systemic signs of infection, production of purulent sputum/endotracheal secretions, new onset of cough, physical examination findings consistent with pneumonia/pulmonary consolidation, dyspnea, and/or tachypnea). Radiographic criteria: new or worsening infiltrate consistent with pneumonia on chest X-ray obtained within 24 hrs of event. Microbiologic criteria: at least 1 culture positive for S aureus (respiratory specimen, or blood, or pleural fluid aspirate or lung tissue culture during episode of pneumonia).

2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days

   Time frame: Day 1 through Day 31

   An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

3. Number of Participants With TEAEs Through 91 Days

   Time frame: Day 1 through Day 91

   An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

4. Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

   Time frame: Day 1 through Day 191

   A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

5. Number of Participants With Adverse Events of Special Interest (AESIs)

   Time frame: Day 1 through Day 191

   An AESI is one 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.

6. Number of Participants With New Onset Chronic Diseases (NOCDs)

   Time frame: Day 1 through Day 191

   An NOCD defined as a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving the study drug and is assessed by the investigator as medically significant.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 33894131Francois B, Jafri HS, Chastre J, Sanchez-Garcia M, Eggimann P, Dequin PF, Huberlant V, Vina Soria L, Boulain T, Bretonniere C, Pugin J, Trenado J, Hernandez Padilla AC, Ali O, Shoemaker K, Ren P, Coenjaerts FE, Ruzin A, Barraud O, Timbermont L, Lammens C, Pierre V, Wu Y, Vignaud J, Colbert S, Bellamy T, Esser MT, Dubovsky F, Bonten MJ, Goossens H, Laterre PF; COMBACTE Consortium and the SAATELLITE Study Group. Efficacy and safety of suvratoxumab for prevention of Staphylococcus aureus ventilator-associated pneumonia (SAATELLITE): a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial. Lancet Infect Dis. 2021 Sep;21(9):1313-1323. doi: 10.1016/S1473-3099(20)30995-6. Epub 2021 Apr 21.
• Derived from this study: PubMed 27795368Yu XQ, Robbie GJ, Wu Y, Esser MT, Jensen K, Schwartz HI, Bellamy T, Hernandez-Illas M, Jafri HS. Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Investigational, Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody, in Healthy Adults. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e01020-16. doi: 10.1128/AAC.01020-16. Print 2017 Jan.
• CD-ID-MEDI4893-1139 Protocol amendment 5\_redacted\_FINAL\_APPROVEDLink provided by the sponsor.
• CD-ID-MEDI4893-1139 Statistical Analysis Plan\_Final v4.0\_Redacted\_FINAL\_APPROVEDLink provided by the sponsor.

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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.

49 sites in 10 countries: see every site and its status.