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Trial record 4 of 7449 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND Anti-Infective Agents

Early Antibiotic Therapy and Vaccination

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ClinicalTrials.gov Identifier: NCT04109833
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Natascha Köstlin-Gille, University Hospital Tuebingen

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
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.

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Study Type : Observational
Estimated 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 : September 27, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort 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 Name: any antibiotic therapy




Primary Outcome Measures :
  1. vaccination reaction [ Time Frame: 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 [ Time Frame: 7 months ]
    microbiome analyses of stool samples at age 14 days and corrected 4 months


Biospecimen Retention:   Samples With DNA
stool samples for microbiome analyses


Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
preterm infants with gestational age between 24+0 and 28+6 weeks of gestation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109833


Contacts
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Contact: Natascha Köstlin-Gille, Dr. med. 0049-7071-2984743 natascha.koestlin@med.uni-tuebingen.de
Contact: Christian Gille, Dr. med. 0049-7071-83972 christian.gille@med.uni-tuebingen.de

Locations
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Germany
University Hospital Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Natascha Köstlin, Dr. med.    0049-7071-2984743    natascha.koestlin@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Natascha Köstlin-Gille, Dr. med. Department for Neonatology at University Hospital Tübingen

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Responsible Party: Dr. Natascha Köstlin-Gille, Junior Research Group Leader, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04109833     History of Changes
Other Study ID Numbers: 368/2019BO1
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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