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

NCT05722938 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2026-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Community-acquired Pneumonia

Interventions

DRUG

Trimodulin

IMP will be administered via IV infusion on 5 consecutive days

DRUG

Placebo (human albumin 1%)

IMP will be administered via IV infusion on 5 consecutive days

Sponsors & Collaborators

  • Biotest

    lead INDUSTRY

Principal Investigators

  • Ricard Ferrer Roca, Dr. · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-09
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Czechia
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • New Zealand
  • Philippines
  • Romania
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05722938 on ClinicalTrials.gov