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

NCT02696902 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: D5470C00004
• Study Type: interventional
• Target: 188
• Locations: 14 countries
• Sites: 78

Brief Summary

Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

Conditions

Pseudomonas Aeruginosa

Keywords

Pseudomonas aeruginosa, Pneumonia

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa

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

  Day 1 through Day 22

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

  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.

  Day 1 through Day 50

• Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

  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.

  Day 1 through Day 50

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

  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.

  Day 1 through Day 50

Secondary Outcomes (6)

• Maximum Observed Concentration (Cmax) of MEDI3902

  Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50

• Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902

  Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50

• Clearance (CL) of MEDI3902

  Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50

• Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose

  Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22

• Terminal Elimination Half-life (t1/2) of MEDI3902

  Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50

Study Arms (3)

MEDI3902 500 mg

EXPERIMENTAL

Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.

Drug: MEDI3902

Placebo

PLACEBO COMPARATOR

Participants will receive a single IV dose of placebo matched to MEDI3902.

Other: Placebo

MEDI3902 1500 mg

EXPERIMENTAL

Participants will receive a single IV dose of 1500 mg MEDI3902.

Drug: MEDI3902

Interventions

MEDI3902 DRUG

Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.

MEDI3902 1500 mg; MEDI3902 500 mg

Placebo OTHER

Participants will receive a single IV dose of placebo matched to MEDI3902.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

You may not qualify if:

• P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics, moribund participants.

Sponsors & Collaborators

• MedImmune LLC: lead
• Innovative Medicines Initiative: collaborator
• Antibacterial Resistance Leadership Group: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (78)

Research Site

Englewood, Colorado, 80113, United States

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Gainesville, Florida, 32608, United States

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Atlanta, Georgia, 30322, United States

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Augusta, Georgia, 30912, United States

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Annapolis, Maryland, 21401, United States

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Boston, Massachusetts, 02111, United States

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Detroit, Michigan, 48202, United States

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Cincinnati, Ohio, 45267, United States

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Innsbruck, 6020, Austria

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Vienna, 1080, Austria

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Bruges, 8000, Belgium

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Brussels, 1020, Belgium

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Brussels, 1090, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Haine-Saint-Paul, 7100, Belgium

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Ottignies, 1340, Belgium

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Slavonski Brod, 35000, Croatia

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Brno, 656 91, Czechia

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Děčín, 405 99, Czechia

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Kolín, 280 02, Czechia

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Kyjov, 697 01, Czechia

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Teplice, 415 29, Czechia

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Argenteuil, 95107, France

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Clermont-Ferrand, 63003, France

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Garches, 92380, France

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La Tronche, 38700, France

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Le Kremlin-Bicêtre, 94275, France

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Le Plessis-Robinson, 92350, France

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Lille, 59037, France

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Limoges, 87042, France

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Montpellier, 34295, France

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Nancy, 54035, France

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Paris, 75014, France

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Paris, 75015, France

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Paris, 75651, France

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Paris, 75679, France

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Pierre-Bénite, 69495, France

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Strasbourg, 67090, France

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Tours, 37000, France

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Athens, 10676, Greece

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Athens, 11521, Greece

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Athens, 11527, Greece

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Athens, 14233, Greece

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Athens, 14564, Greece

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Larissa, 41110, Greece

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Larissa, 41221, Greece

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Thessaloniki, 54634, Greece

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Budapest, 1121, Hungary

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Kistarcsa, 02143, Hungary

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Vác, 2600, Hungary

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Dublin, 6, Ireland

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Jerusalem, 91120, Israel

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Petah Tikva, 4941492, Israel

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Ramat Gan, 5265601, Israel

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Tel Aviv, 6423906, Israel

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Almada, 2805-267, Portugal

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Lisbon, 1449-005, Portugal

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Lisbon, 1649-035, Portugal

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Viana do Castelo, 4904-858, Portugal

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Barcelona, 08025, Spain

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Barcelona, 08036, Spain

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Córdoba, 14004, Spain

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Getafe, 28905, Spain

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Madrid, 28040, Spain

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Oviedo, 33011, Spain

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San Sebastián de los Reyes, 28702, Spain

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Santander, 39008, Spain

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Tarragona, 43007, Spain

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Terrassa, 08221, Spain

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Valencia, 46026, Spain

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Valladolid, 47012, Spain

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Ankara, 6100, Turkey (Türkiye)

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Istanbul, 34890, Turkey (Türkiye)

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Trabzon, 61080, Turkey (Türkiye)

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Edgbaston, B15 2GW, United Kingdom

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London, SE1 7EH, United Kingdom

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London, SE5 9RS, United Kingdom

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Related Publications (1)

• Chastre 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.

  PMID: 36380312 DERIVED

Related Links

• Redacted CSP for CT.gov results
• D5470C00004 Redacted SAP for CT.gov results

MeSH Terms

Conditions

Pseudomonas Infections; Pneumonia

Interventions

gremubamab

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Mark Esser
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+1 301 3986849

Study Officials

• MedImmune LLC

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: March 2, 2016
• Study Start: March 25, 2016
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: February 4, 2021
• Results First Posted: December 23, 2020

Record last verified: 2021-01

Locations

IE (1); BE (7); US (8); FR (17); GR (8); CZ (5); AU (2); HU (3); ES (12); IL (4); CR (1); TU (3); PT (4); GB (3)