Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Biotest
Study ID
NCT05722938
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Community-acquired Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trimodulin — DRUG
    IMP will be administered via IV infusion on 5 consecutive days
  • Placebo (human albumin 1%) — DRUG
    IMP will be administered via IV infusion on 5 consecutive days

Study Details

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

Key Dates

First listed
Feb 10, 2023
Start date
Sep 9, 2023
Status verified
Sep 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
590 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trimodulin
    Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.
  • Placebo Comparator: Placebo
    Human albumin 1%

Primary Outcome Measure

28-day all-cause mortality rate [ Time Frame: Between days 1-29 ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
#1012 Pulmonary Associates of Mobile, P.C.MobileAlabama36608-
# 1033 Banner University Medical CenterPhoenixArizona85006-
#1007 University of California San Francisco-FresnoFresnoCalifornia93701-
# 1015 UC Davis HealthSacramentoCalifornia95817-
# 1002 Augusta UniversityAugustaGeorgia30912-
# 1028 University of Maryland, BaltimoreBaltimoreMaryland21201-
# 1034 Brigham and Women's HospitalBostonMassachusetts02115-
# 1010 Sparrow Clinical Research Institute Site 1010LansingMichigan48912-
# 1003 William Beaumont HospitalRoyal OakMichigan48073-
#1009 University of Missouri Clinical Research CenterColumbiaMissouri65212-
# 1006 Hannibal ClinicHannibalMissouri63401-
# 1005 Mercury Street Medical GroupButteMontana59701-
# 1001 St. Michael's Medical CenterNewarkNew Jersey07102-
# 1011 Buffalo VA Medical CenterBuffaloNew York14215-
# 1021 Northern Westchester HospitalMount KiscoNew York10549-
# 1023 Mount Sinai HospitalNew YorkNew York10029-
# 1030 NYU Langone Medical Center (Tisch Hospital)New YorkNew York10016-
# 1031 Health Hospitals BellvueNew YorkNew York10016-
# 1032 NYC Langone BrooklynNew YorkNew York11220-
# 1017 Wake Forest BaptistWinston-SalemNorth Carolina27157-
# 1025 University of Cincinnati College of MedicineCincinnatiOhio45267-
# 1004 Ohio State University Wexner Medical CenterColumbusOhio43210-
# 1013 University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
# 1016 Jefferson University HospitalsPhiladelphiaPennsylvania19107-
# 1018 Vanderbilt University Medical CenteNashvilleTennessee37232-
# 1020 Medical City Fort WorthFort WorthTexas76104-
# 1022 Houston Methodist HospitalHoustonTexas77030-
# 1022 Houston Methodist HospitalHoustonTexas77030-
# 1026 Intermountain Medical CenterMurrayUtah84107-
# 1019 University of UtahSalt Lake CityUtah84108-

Find similar trials in Mobile, AL

By research site
#1012 Pulmonary Associates of Mobile, P.C.· Mobile, AL# 1033 Banner University Medical Center· Phoenix, AZ#1007 University of California San Francisco-Fresno· Fresno, CA# 1015 UC Davis Health· Sacramento, CA# 1002 Augusta University· Augusta, GA# 1028 University of Maryland, Baltimore· Baltimore, MD

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