Early Antibiotic Therapy and Vaccination

Vaccination Reaction Clinical Trial

Official title:

Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109833
• Other study ID #: 368/2019BO1
• Status: Recruiting
• Start date: September 27, 2019
• Est. completion date: October 2021

Study information

• Verified date: September 2019
• Source: University Hospital Tuebingen
• Contact: Natascha Köstlin-Gille, Dr. med.
• Phone: 0049-7071-2984743
• Email: natascha.koestlin[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Neonatal Sepsis is one of the most common causes of death in preterm infants. Therefore, up to 80% of very low birth weight infants receive antibiotic therapy in their first week of life. Antibiotic therapy is one of the most important influencing factors for the establishment of the intestinal microbiome, which in turn modulates neonatal immune development. In this pilot study, it will be investigated, if antibiotic therapy in the first week of life influences the vaccination response of preterm infants.

Description:

The aim of the study is to compare antibody titers against Hepatitis B, Polio, Pertussis, Haemophilus influenza B, Tetanus, Diphteria and Pneumococcus in very low birth weight infants (VLBWI) infants who received antibiotic therapy in their first week of life and who did not. In this pilot study, 20 VLBWI infants will be included (10 per group). Infants will be matched fo age and gender.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 28 Weeks

Eligibility

Inclusion Criteria:

• born at University Hospital Tübingen

• at least one dose of antibiotics within the first week of life

Exclusion Criteria:

• genetic disorders

• chronic infections

• hematological disorders

• immunoglobulins within the first 60 days of life

• immunological disorders

• infants from Hepatitis B positive mothers

Related Conditions & MeSH terms

• Vaccination Reaction

Intervention

Drug:
• ABT
any antibiotic therapy in the first week of life

Locations

Country	Name	City	State
Germany	University Hospital	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vaccination reaction	measurement of antibody titers for Hepatitis B, Polio, Pertussis, Haemophilus Influenza B, Tetanus, Diphteria and Pneumococcus 4 months after the first vaccination (at an age of 6 months)	7 months
Secondary	Microbiome composition	microbiome analyses of stool samples at age 14 days and corrected 4 months	7 months