Vaccination ReactionNCT04109833
Early Antibiotic Therapy and Vaccination
An observational study of Vaccination Reaction, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 24 to 28 weeksHealthy volunteers can take part
- Conditions the study is for
- Vaccination Reaction
- What is being tested?
- ABT
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 27 Sep 2019to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 28 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: preterm infants with gestational age between 24+0 and 28+6 weeks of gestation
Who may be able to join
- born at University Hospital Tübingen
- at least one dose of antibiotics within the first week of life
Who cannot join
- genetic disorders
- chronic infections
- hematological disorders
- immunoglobulins within the first 60 days of life
- immunological disorders
- infants from Hepatitis B positive mothers
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital
Tübingen, Baden-Wurttemberg, 72076
Natascha Köstlin, Dr. med., 0049-7071-2984743, natascha.koestlin@med.uni-tuebingen.de
About this study
Official title: Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
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.
Read the 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.
- Conditions
- Vaccination Reaction
- Being tested
- ABT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABTDrug
Also called any antibiotic therapy
any antibiotic therapy in the first week of life
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ABT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 months
Secondary outcomes (1)
Microbiome composition
microbiome analyses of stool samples at age 14 days and corrected 4 months
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start27 Sep 2019
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Natascha Köstlin-Gille, University Hospital Tuebingen
- Investigators
- Natascha Köstlin-Gille, Dr. med., Principal investigator, Department for Neonatology at University Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109833
- Sponsor's protocol ID
- 368/2019BO1
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
- ClinicalTrials.gov ID
- NCT04109833
- Acronym / sponsor ID
- 368/2019BO1
- Conditions
- Vaccination Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: ABTVLBWI with gestational age between 24+0 and 28+6 weeks of gestation with antibiotic treatment in the first week of life |
Who may qualify
- Ages
- 24 to 28 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- preterm infants with gestational age between 24+0 and 28+6 weeks of gestation
Key inclusion criteria (2 listed)
- born at University Hospital Tübingen
- at least one dose of antibiotics within the first week of life
Key exclusion criteria (6 listed)
- genetic disorders
- chronic infections
- hematological disorders
- immunoglobulins within the first 60 days of life
- immunological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABTAlso: any antibiotic therapyany antibiotic therapy in the first week of life | Drug | ABT in the first week of life |
Primary outcome
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)
1 secondary outcome
Microbiome composition
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natascha Köstlin-Gille, Dr. med. principal investigator
Department for Neonatology at University Hospital Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination Reaction, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natascha Köstlin-Gille, Dr. med. (0049-7071-2984743, natascha.koestlin@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaccination reaction (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.