NCT05063149 Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
| NCT ID | NCT05063149 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Franciscus Gasthuis |
| Condition | Wheezing |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-01-18 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2022-01-18 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Gestational age at delivery between 30+0 and 35+6 weeks * Postnatal age at least 6 weeks at randomization \& postmenstrual age at least 37 weeks * Written informed consent by both parents or formal caregivers Exclusion Criteria: * Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder. * Lower RTI before randomization * Dysmaturity and/or weight \< 2.5 kg at age of randomization. * Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding * Parents unable to speak and read Dutch/English language * Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05063149 clinical trial?
This trial is open to participants of all sexes, aged 6 Weeks or older, up to 10 Weeks, studying Wheezing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05063149 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT05063149 currently recruiting?
Yes, NCT05063149 is actively recruiting participants. Contact the research team at proteastudie@franciscus.nl for enrollment information.
Where is the NCT05063149 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05063149 clinical trial?
NCT05063149 is sponsored by Franciscus Gasthuis. The trial plans to enroll 500 participants.