Early Antibiotic Therapy and Vaccination

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04109833
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 24.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vaccination Reaction	Drug: ABT

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
• Actual Study Start Date: Sep 27, 2019
• Anticipated Primary Completion Date: Oct 1, 2021
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
no antibiotic therapy (ABT) in the first week of life VLBWI with gestational age between 24+0 and 28+6 weeks of gestation without antibiotic treatment in the first week of life
ABT in the first week of life VLBWI with gestational age between 24+0 and 28+6 weeks of gestation with antibiotic treatment in the first week of life	Drug: ABT; any antibiotic therapy in the first week of life; Other Names: any antibiotic therapy

Outcome Measures

Primary Outcome Measures

1. vaccination reaction [7 months]

   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)

Secondary Outcome Measures

1. Microbiome composition [7 months]

   microbiome analyses of stool samples at age 14 days and corrected 4 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Weeks to 28 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Tübingen	Baden-Württemberg	Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

• Principal Investigator: Natascha Köstlin-Gille, Dr. med., Department for Neonatology at University Hospital Tübingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Natascha Köstlin-Gille, Junior Research Group Leader, University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT04109833
• Other Study ID Numbers: 368/2019BO1
• First Posted: Sep 30, 2019
• Last Update Posted: Sep 30, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anti-Bacterial Agents

Study Results

No Results Posted as of Sep 30, 2019