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
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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 adult 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

Start date
Sep 9, 2023
Status verified
Feb 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 (19)

FacilityCityStateZIPSite coordinators
Pulmonary Associates of Mobile, P.C.MobileAlabama36608-
University of California San Francisco-FresnoFresnoCalifornia93701-
UC Davis HealthSacramentoCalifornia95817-
Augusta UniversityAugustaGeorgia30912-
Sparrow Clinical Research InstituteLansingMichigan48912-
William Beaumont HospitalRoyal OakMichigan48073-
University of Missouri Clinical Research CenterColumbiaMissouri65212-
Hannibal ClinicHannibalMissouri63401-
Mercury Street Medical GroupButteMontana59701-
St. Michael's Medical CenterNewarkNew Jersey07102-
Buffalo VA Medical CenterBuffaloNew York14215-
Lenox Hill HospitalNew YorkNew York10075-1850-
Wake Forest BaptistWinston-SalemNorth Carolina27157-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Jefferson University HospitalsPhiladelphiaPennsylvania19107-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Medical City Fort WorthFort WorthTexas76104-
Houston Methodist HospitalHoustonTexas77030-
University of UtahSalt Lake CityUtah84108-

Find similar trials in Mobile, AL

By research site
Pulmonary Associates of Mobile, P.C.· Mobile, ALUniversity of California San Francisco-Fresno· Fresno, CAUC Davis Health· Sacramento, CAAugusta University· Augusta, GASparrow Clinical Research Institute· Lansing, MIWilliam Beaumont Hospital· Royal Oak, MI

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