Clinical Trial

Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

Study acronym: PROTEA
Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated August 22, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-09-20; most recent amendment 2024-08-20.
Status change: Not Yet Recruiting → Recruiting 2022-02-19
Trial Details
NCT Number NCT05063149
Lead Sponsor Franciscus Gasthuis
Collaborators: Leiden University Medical Center, Maastricht University Medical Center
Conditions Wheezing, LRTI, Premature
Enrollment 500 participants
Start Date 2022-01-18
Primary Completion 2025-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2024-08-22