Clinical trial looking at the safety and efficacy of MEDI3902 in the prevention of Pseudomonas aeruginosa pneumonia occurring in the hospital

Conditions

Prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa MedDRA version: 18.1 Level: LLT Classification code 10051190 Term: Pneumonia Pseudomonas aeruginosa System Organ Class: 100000004862

Chastre J, François B, Bourgeois M, Komnos A, Ferrer R, Rahav G, De Schryver N, Lepape A, Koksal I, Luyt CE, Sánchez-García 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.

2022-11-1559 citations

10.1186/s13054-022-04204-9

635. Efficacy, Pharmacokinetics (PK), and Safety Profile of MEDI3902, an Anti-<i>Pseudomonas aeruginosa</i> Bispecific Human Monoclonal Antibody in Mechanically Ventilated Intensive Care Unit Patients; Results of the Phase 2 EVADE Study Conducted by the Public-Private COMBACTE-MAGNET Consortium in the Innovative Medicines Initiative (IMI) Program

Jean Chastre, Bruno François, Marc Bourgeois, Apostolos Komnos, Ricard Ferrer et al. (25 authors)

Open Forum Infectious Diseases2020-10-0116 citations

10.1093/ofid/ofaa439.829

Interventions

Product Name: MEDI3902 Product Code: MEDI3902 Pharmaceutical Form: Solution for infusion INN or Proposed INN: NA CAS Number: NA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Colonized with Pseudomonas aeruginosa in respiratory tract, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 215 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 214

Exclusion criteria

Exclusion criteria: Pseudomonas disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving anti-pseudomonas antibiotics; moribund patients.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa 2. To evaluate the safety of a single IV dose of MEDI3902 in mechanically ventilated patients ;Timepoint(s) of evaluation of this end point: Through 49 days postdose; Secondary Objective: 1. To evaluate the serum pharmacokinetics (PK) of MEDI3902 2. To evaluate the serum anti-drug antibody (ADA) responses to MEDI3902 3. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa by mechanical ventilation status ; Primary end point(s): - Incidence of nosocomial pneumonia caused by P aeruginosa - Treatment emergent adverse events (TEAEs) treatment emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs) through 49 days postdose	—

Measure

Time frame

Main Objective: 1. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa 2. To evaluate the safety of a single IV dose of MEDI3902 in mechanically ventilated patients ;Timepoint(s) of evaluation of this end point: Through 49 days postdose; Secondary Objective: 1. To evaluate the serum pharmacokinetics (PK) of MEDI3902 2. To evaluate the serum anti-drug antibody (ADA) responses to MEDI3902 3. To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa by mechanical ventilation status ; Primary end point(s): - Incidence of nosocomial pneumonia caused by P aeruginosa - Treatment emergent adverse events (TEAEs) treatment emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs) through 49 days postdose

—

Secondary

Measure	Time frame
Secondary end point(s): 1. MEDI3902 serum concentration and PK parameters 2. MEDI3902 ADA response in serum 3. Incidence of nosocomial pneumonia caused by P aeruginosa while on mechanical ventilation 4. Incidence of nosocomial pneumonia caused by P aeruginosa after mechanical ventilation is no longer required ;Timepoint(s) of evaluation of this end point: Through 49 days postdose	—

Countries

Austria, Belgium, Bulgaria, Croatia, Czech Republic, France, Germany, Greece, Hungary, Israel, Portugal, Romania, Slovakia, Spain, Switzerland, Turkey, United Kingdom

Contacts

Public ContactClinical Trial Enquiries

MedImmune

RegistroEspanolDeEstudiosClinicos@druginfo.com+34900834223

Outcome results

None listed