Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first year of life by using bacterial lysates

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sint Franciscus Vlietland Groep Stichting

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]

Trial duration

5 Dec 2024 → ongoing

Decision date (initial)

2024-12-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

OM Pharma, Switseland (in kind) · Longfonds Nederland - monetary support · Ventica, Finland (in kind)

External identifiers

EU CT number

2024-518498-32-01

EudraCT number

2020-005868-67

ClinicalTrials.gov

NCT05063149

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis

We hypothesize that early education of the neonatal immune system by daily stimulation with microbial elements leads to better protection against lower RTI and subsequent wheezing episodes. It enhances self-initiated antimicrobial immunity by improved and accelerated immune maturation. This will lead to a significant health gain in preterm-born infants with enhanced risk for respiratory diseases.
Moreover, we hypothesize that prolonged bacterial lysate therapy after preterm birth leads to a delay in lower respiratory tract symptoms compared to a shorter treatment. Thus, our main objective is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration.

Secondary objectives 4

1. To compare the efficacy of 1 versus 2-year bacterial lysate therapy for the prevention of lower respiratory episodes in moderate-late preterm infants in their first two years of life.
2. Analyze the impact of bacterial lysates on mucosal and systemic immune maturation and microbiome diversity and maturation
3. Identify biomarkers predicting development of early respiratory episodes (high risk group) and response to bacterial lysate administration in order to facilitate personalized treatment
4. To calculate cost-effectiveness of all bacterial lysate treatment regimens.

Conditions and MedDRA coding

Lower respiratory tract infections and wheezing in moderate-late premature infants

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Gestational age at delivery between 30+0 and 35+6 weeks
2. Postnatal age at least 6 weeks at randomization & postmenstrual age at least 37 weeks
3. Written informed consent by both parents or formal caregivers

Exclusion criteria 5

1. Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (un-expected in this group); hemodynamic significant cardiac disease; immunodeficiency; severe failure to thrive; birth asphyxia with predicted poor neurological outcome; syn-drome or serious congenital disorder.
2. Dysmaturity and/or weight < 2.5 kg at age of randomization
3. Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding
4. Parents unable to speak and read Dutch/English language
5. Known allergic hypersensitivity to the active ingredients/substance or to any of the ex-cipients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Protea-1: Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life.
2. Protea-2: The time to the first lower respiratory episode after 12 months of age.

Secondary endpoints 11

1. time to first lower RTI or wheezing episode in the first year of life
2. total number of RTI in the first and second year of life
3. total number of wheezing episodes in the first and second year of life
4. distribution of viruses during lower RTI/wheezing
5. medication use (bronchodilators, corticosteroids, antibiotics)
6. lung function as measured by expiratory variability index
7. quality of life
8. (serious) adverse events (respiratory episodes are not regarded as an (S)AE since they comprise primary and secondary outcomes)
9. serum specific IgE (allergen sensitization) at 12 months
10. infant vaccination titers at 12 months
11. costs- and cost-effectiveness

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Franciscus Vlietland Groep Stichting

Sponsor organisation

Sint Franciscus Vlietland Groep Stichting

Address

Kleiweg 500

City

Rotterdam

Postcode

3045 PM

Country

Netherlands

Scientific contact point

Organisation

Sint Franciscus Vlietland Groep Stichting

Contact name

Research Bureau (Wetenschapsbureau)

Public contact point

Organisation

Sint Franciscus Vlietland Groep Stichting

Contact name

Research Bureau (Wetenschapsbureau)

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications