MedTrace Logo

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

NCT05063149 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-08-22

No results posted yet for this study

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.

Conditions

  • Wheezing
  • LRTI
  • Premature

Interventions

DRUG

Broncho-Vaxom

Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.

OTHER

Placebo

Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • Franciscus Gasthuis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT05063149 on ClinicalTrials.gov