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

NCT05063149 | Recruiting Phase 3 DMC

• 1 other identifier: NL76165.100.20
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Wheezing; LRTI; Premature

Outcome Measures

Primary Outcomes (1)

• Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life

  Recorded by frequent questionnaires

  In the first year of life.

Secondary Outcomes (11)

• Time to first lower RTI or wheezing episode

  In the first and second year of life.

• Total number of RTI

  In the first and second year of life.

• Total number of wheezing episodes

  In the first and second year of life.

• Distribution of viruses

  In the first year of life.

• Medication use (bronchodilators, corticosteroids, antibiotics)

  In the first and second year of life.

Other Outcomes (9)

• Gut and respiratory microbiome composition

  In the first year of life.

• Secretory IgA in saliva

  In the first year of life

• Immune maturation: immune cells in nasal epithelium

  In the first year of life

Study Arms (2)

Broncho-Vaxom treatment

ACTIVE COMPARATOR

Infants in this arm will be given 3,5mg bacterial lysate (OM-85) 10 days per month from 6 weeks after birth until 12 months of age. At age 12 months they will be (if informed consent for Protea-2 is provided) randomised over Broncho-Vaxom treatment and placebo again.

Drug: Broncho-Vaxom

Placebo

PLACEBO COMPARATOR

Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug.

Other: Placebo

Interventions

Broncho-Vaxom DRUG

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

Also known as: OM-85, Broncho-Vaxom concentrate (Bacterial lysate)

Broncho-Vaxom treatment

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 6 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franciscus Gasthuis: lead
• Leiden University Medical Center: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (1)

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, 3045PM, Netherlands

RECRUITING

Related Publications (45)

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MeSH Terms

Conditions

Respiratory Sounds; Premature Birth

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Inger van Duuren

CONTACT

0031 10 893 61 69; proteastudie@franciscus.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study subjects, all study investigators including the principal investigator and treating physicians will be blinded for the allocation during the complete study period. A sealed envelope with the treatment allocation per code is present at the pharmacy to be used only when 1) crucial for a medical emergency, 2) the participant will continue with Protea-2 and the database concerning year 1 is locked for this specific participant, and 3) at trial completion after the last patient last visit.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician/clinical researcher, principal investigator

Model Details: Half of the participants (250) will receive treatment (Broncho-Vaxom) and the other half will receive placebo. Randomization will be stratified for gestational age (moderate (30+0-32+6) vs. late (33+0-35+6) prematurity). In the follow-up study Protea-2, infants from the treatment arm in year 1 will be randomised to receive Broncho-Vaxom or placebo in year 2. Randomisation will stratified for gestational age again, but also for the amount of lower respiratory episodes in year 1 (\<2 vs. \>/=2) Infants from the control arm in year 1 will not receive treatment in year 2.

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 30, 2021
• Study Start: January 18, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will come available after publication of the data in articles by initating researchers.
• Access Criteria: Data will be available under restricted access. A request for data sharing will include at least the reason for request (for what will the receiver use the data?) and agreements about authorship.

Locations

NL (1)