Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa

ClinicalTrials.gov ID

NCT02696902

Acronym / sponsor ID

EVADE / D5470C00004

Conditions

Pseudomonas Aeruginosa

Keywords

Pseudomonas aeruginosa, Pneumonia

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

188 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

25 Mar 2016 (actual)

Primary completion

4 Dec 2019 (actual)

Study completion

4 Dec 2019 (actual)

First posted

2 Mar 2016 (estimated)

Results

Posted 23 Dec 2020

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 99 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 Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa

   Time frame: Day 1 through Day 22

   Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.

2. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

   Time frame: Day 1 through Day 50

   An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The 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 Treatment-emergent Serious Adverse Events (TESAEs)

   Time frame: Day 1 through Day 50

   An 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.

4. Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)

   Time frame: Day 1 through Day 50

   An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor. An AESI may be serious or non-serious.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 36380312Chastre J, Francois B, Bourgeois M, Komnos A, Ferrer R, Rahav G, De Schryver N, Lepape A, Koksal I, Luyt CE, Sanchez-Garcia M, Torres A, Eggimann P, Koulenti D, Holland TL, Ali O, Shoemaker K, Ren P, Sauser J, Ruzin A, Tabor DE, Akhgar A, Wu Y, Jiang Y, DiGiandomenico A, Colbert S, Vandamme D, Coenjaerts F, Malhotra-Kumar S, Timbermont L, Oliver A, Barraud O, Bellamy T, Bonten M, Goossens H, Reisner C, Esser MT, Jafri HS; COMBACTE-MAGNET EVADE Study Group. Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial. Crit Care. 2022 Nov 15;26(1):355. doi: 10.1186/s13054-022-04204-9.
• Redacted CSP for CT.gov resultsLink provided by the sponsor.
• D5470C00004 Redacted SAP for CT.gov resultsLink provided by the sponsor.

Related trials for Pseudomonas Aeruginosa

• RecruitingPhase 4

  CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients

  Severe Infection

• RecruitingPhase 4

  EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

  Blood Stream Infections, Ventilator Associated Pneumonia

• Active, not recruitingPhase 1

  A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa

  Healthy Participants, Non-cystic Fibrosis Bronchiectasis

• RecruitingPhase 2

  A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

  Bronchiectasis With Pseudomonas Aeruginosa Colonization

• RecruitingPhase 2

  A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

  Bronchiectasis With Pseudomonas Aeruginosa Colonization

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.

78 sites in 14 countries: see every site and its status.