Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722938
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-01-11
Brief Title:
Efficacy and Safety of Trimodulin BT588 in Subjects With Severe Community-acquired Pneumonia sCAP
Sponsor:
Biotest
Organization:
Biotest
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Multi-center Phase III Trial to Assess the Efficacy and Safety of Trimodulin BT588 in Adult Hospitalized Subjects With Severe Community-acquired Pneumonia sCAP
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESsCAPE
Brief 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
Other objectives are to determine detailed pharmacokinetic PK properties of trimodulin in a PK substudy and to determine its pharmacodynamic PD properties
Detailed Description:
This is a randomized placebo-controlled double-blind multi-center multi-national phase III trial to assess the efficacy and safety of trimodulin compared to placebo treatment as adjunctive treatment to SoC in adult hospitalized subjects with sCAP receiving IMV
Subjects will be randomized on a 11 basis to receive trimodulin or placebo stratified by center Investigational medicinal product IMP treatments will be blinded
Subject will be administered IMP once daily on 5 consecutive days day 1 through day 5 adjunctive to SoC The subsequent follow-up phase comprises maximally 23 days day 6 through day 28 followed by an end-of-follow-up visittelephone call on day 29 3 For subjects still in the hospital trial site after day 29 an extended follow-up is conducted until discharge or until day 90 For all subjects alive on day 29 a closing visittelephone call on day 91 10 will be done
Subjects will be randomized on a 11 basis to receive trimodulin or placebo stratified by center Investigational medicinal product IMP treatments will be blinded
Subject will be administered IMP once daily on 5 consecutive days day 1 through day 5 adjunctive to SoC The subsequent follow-up phase comprises maximally 23 days day 6 through day 28 followed by an end-of-follow-up visittelephone call on day 29 3 For subjects still in the hospital trial site after day 29 an extended follow-up is conducted until discharge or until day 90 For all subjects alive on day 29 a closing visittelephone call on day 91 10 will be done
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None