Early Onset Neonatal SepsisNCT00487019
Management of Early Onset Neonatal Septicaemia: Selection of Optimal Antibacterial Regimen for Empiric Treatment
An observational study of Early Onset Neonatal Sepsis, run by University of Tartu at 2 sites in Estonia.
Trial summary
A prospective two-center antibiotic regimen switch study will be conducted to compare the clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus ampicillin/gentamicin - in the empirical treatment of early onset neonatal sepsis. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Early Onset Neonatal Sepsis
- How many people
- 281 participants
- Where
- 2 sitesEstonia
- Study dates
- Aug 2006to Dec 2007
- 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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: Neonates hospitalised within 72h of life and requiring empirical antibacterial treatment for early onset neonatal sepsis.
Who may be able to join
- All neonates, admitted to the study NICU-s at the age of less than 72 hours and needing early empiric antibiotic treatment according to pre-defined criteria as described by Schrag et al. (2002)
Who cannot join
- Subjects, who on clinical or other indications (e.g. suspected/proven meningitis or abdominal cavity infection, isolation of resistant bacteria from the mother of a neonate with severe sepsis) need antibiotic treatment other than specified in the study protocol and infants who are likely to be transferred to other units within 24 hours.
Trial locations and contacts
2 sites in 1 country.
Estonia2 sites
Tallinń's Childrens Hospital, Paediatric Intensive Care Unit
Tallinn
Tartu University Clinics, Department of Paediatric Intensive Care
Tartu, 50411
About this study
Official title: Comparative Study of Two Antibiotic Regimen - Penicillin G/Gentamicin Versus Ampicillin/Gentamicin in Empirical Treatment of Early Onset Neonatal Septicaemia
A prospective two-center antibiotic regimen switch study will be conducted to compare the clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus ampicillin/gentamicin - in the empirical treatment of early onset neonatal sepsis. The influence of either regimen on bowel colonization pattern and on the development of antibiotic resistance of gut microflora will also be assessed. The primary endpoint is the need for a change in antibacterial treatment within 72 hours of therapy, based on pre-defined criteria. Secondary endpoints will be the incidence rate and etiology of early and late onset neonatal sepsis and susceptibility pattern of causative microorganisms; mortality rate within 60 days; duration of hospitalization in NICU; duration of artificial ventilation; colonization pattern and susceptibility of colonizing bacteria (including resistance to empiric antibiotic regimen).
Read the detailed description
A prospective randomized two-centre antibiotic regimen switch study will be conducted in the NICU-s of Tartu University Clinics and of Tallinn Children's Hospital. Initially all patients who need empiric treatment for early onset neonatal sepsis (as defined by Schrag et al. 2002) in Tartu will be treated with penicillin/gentamicin and those in Tallinn with ampicillin/gentamicin. When half of the needed subjects have been recruited, departmental antibiotic regimen will be switched so that ampicillin is used in Tartu and penicillin in Tallinn. Based on the present patient population and hospitalization rate, about 120-150 babies, eligible for the study will be admitted to either units every a year.
In all subjects predefined pre- and intranatal risk factors of infection will be registered. During the NICU stay laboratory and clinical signs of infection, need for respiratory support and vasoactive therapy, enteral and parenteral nutrition will be recorded.
Blood, CSF and urine cultures will be taken according to the routine of the ward but certainly before every change in antibacterial treatment. For colonization studies nasopharyngeal or tracheal and anal swabs will be collected from all neonates admitted during the study period on admission and thereafter biweekly until discharge from the NICU or until the 60th day of treatment. A separate protocol will be followed for microbiological investigations.
The endpoints:
The primary endpoint is the need for a change in antibacterial treatment within 72 hours. In discussions with clinical experts in both wards the following criteria for the change in antibacterial treatment were defined:
- proven or suspected meningitis or abdominal infection
- isolation from a relevant site of the mother or an infant of a microorganism, resistant to initial empiric treatment regimen in babies with early onset neonatal sepsis or septic shock
- deterioration of the clinical status on initial antibiotic regimen and suspected/proven neonatal sepsis
- suspected/proven late onset sepsis or nosocomial infection (defined as the development of clinical/ laboratory signs of infection at postnatal age of 72 hours or more)
- other situations, where the treating physician considers change in antibiotic regimen necessary - the reasons will be recorded in the case report form Patients, who die before 72 hours or in whom the antibacterial therapy is changed for other than the above-mentioned reasons, will be handled as treatment failures.
Secondary endpoints will be the following:
- incidence rate and etiology of early and late onset neonatal sepsis, susceptibility pattern of causative microorganisms
- incidence rate and etiology of nosocomial sepsis, susceptibility pattern of causative microorganisms
- mortality rate within 60 days
- duration of hospitalization in NICU stay
- duration of artificial ventilation
- colonization pattern and susceptibility of colonizing bacteria (including resistance to empiric antibiotic regimen).
- Conditions
- Early Onset Neonatal Sepsis
- Keywords
- ampicillin, penicillin G, gentamicin, neonatal sepsis, empiric therapy
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Neonates aged <72 h and needing antibacterial therapy for early onset neonatal sepsis | |
| 2 | Same as group 1 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startAug 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Onset Neonatal SepsisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Estonian Science Foundation, European Society for Paediatric Infectious Diseases
- Investigators
- Irja Lutsar, MD, PhD, Study chair, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487019
- Sponsor's protocol ID
- 038FAR042005
- Status last verified
- May 2008
- First submitted
- 14 Jun 2007
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Schrag S, Gorwitz R, Fultz-Butts K, Schuchat A. Prevention of perinatal group B streptococcal disease. Revised guidelines from CDC. MMWR Recomm Rep. 2002 Aug 16;51(RR-11):1-22.
PubMed 12211284
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Antibiotic Regimen - Penicillin G/Gentamicin Versus Ampicillin/Gentamicin in Empirical Treatment of Early Onset Neonatal Septicaemia
- ClinicalTrials.gov ID
- NCT00487019
- Acronym / sponsor ID
- 038FAR042005
- Conditions
- Early Onset Neonatal Sepsis
- Keywords
- ampicillin, penicillin G, gentamicin, neonatal sepsis, empiric therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Estonian Science Foundation, European Society for Paediatric Infectious Diseases
- Study start
- Aug 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Jun 2007 (estimated)
- 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.
A prospective two-center antibiotic regimen switch study will be conducted to compare the clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus ampicillin/gentamicin - in the empirical treatment of early onset neonatal sepsis. The influence of either regimen on bowel colonization pattern and on the development of antibiotic resistance of gut microflora will also be assessed. The primary endpoint is the need for a change in antibacterial treatment within 72 hours of therapy, based on pre-defined criteria. Secondary endpoints will be the incidence rate and etiology of early and late onset neonatal sepsis and susceptibility pattern of causative microorganisms; mortality rate within 60 days; duration of hospitalization in NICU; duration of artificial ventilation; colonization pattern and susceptibility of colonizing bacteria (including resistance to empiric antibiotic regimen).
Detailed description
A prospective randomized two-centre antibiotic regimen switch study will be conducted in the NICU-s of Tartu University Clinics and of Tallinn Children's Hospital. Initially all patients who need empiric treatment for early onset neonatal sepsis (as defined by Schrag et al. 2002) in Tartu will be treated with penicillin/gentamicin and those in Tallinn with ampicillin/gentamicin. When half of the needed subjects have been recruited, departmental antibiotic regimen will be switched so that ampicillin is used in Tartu and penicillin in Tallinn. Based on the present patient population and hospitalization rate, about 120-150 babies, eligible for the study will be admitted to either units every a year.
In all subjects predefined pre- and intranatal risk factors of infection will be registered. During the NICU stay laboratory and clinical signs of infection, need for respiratory support and vasoactive therapy, enteral and parenteral nutrition will be recorded.
Blood, CSF and urine cultures will be taken according to the routine of the ward but certainly before every change in antibacterial treatment. For colonization studies nasopharyngeal or tracheal and anal swabs will be collected from all neonates admitted during the study period on admission and thereafter biweekly until discharge from the NICU or until the 60th day of treatment. A separate protocol will be followed for microbiological investigations.
The endpoints:
The primary endpoint is the need for a change in antibacterial treatment within 72 hours. In discussions with clinical experts in both wards the following criteria for the change in antibacterial treatment were defined:
- proven or suspected meningitis or abdominal infection
- isolation from a relevant site of the mother or an infant of a microorganism, resistant to initial empiric treatment regimen in babies with early onset neonatal sepsis or septic shock
- deterioration of the clinical status on initial antibiotic regimen and suspected/proven neonatal sepsis
- suspected/proven late onset sepsis or nosocomial infection (defined as the development of clinical/ laboratory signs of infection at postnatal age of 72 hours or more)
- other situations, where the treating physician considers change in antibiotic regimen necessary - the reasons will be recorded in the case report form Patients, who die before 72 hours or in whom the antibacterial therapy is changed for other than the above-mentioned reasons, will be handled as treatment failures.
Secondary endpoints will be the following:
- incidence rate and etiology of early and late onset neonatal sepsis, susceptibility pattern of causative microorganisms
- incidence rate and etiology of nosocomial sepsis, susceptibility pattern of causative microorganisms
- mortality rate within 60 days
- duration of hospitalization in NICU stay
- duration of artificial ventilation
- colonization pattern and susceptibility of colonizing bacteria (including resistance to empiric antibiotic regimen).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Neonates aged <72 h and needing antibacterial therapy for early onset neonatal sepsis |
| 2 | – | –Same as group 1 |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates hospitalised within 72h of life and requiring empirical antibacterial treatment for early onset neonatal sepsis.
Key inclusion criteria (1 listed)
- All neonates, admitted to the study NICU-s at the age of less than 72 hours and needing early empiric antibiotic treatment according to pre-defined criteria as described by Schrag et al. (2002)
Key exclusion criteria (1 listed)
- Subjects, who on clinical or other indications (e.g. suspected/proven meningitis or abdominal cavity infection, isolation of resistant bacteria from the mother of a neonate with severe sepsis) need antibiotic treatment other than specified in the study protocol and infants who are likely to be transferred to other units within 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2008.
- Background: PubMed 12211284Schrag S, Gorwitz R, Fultz-Butts K, Schuchat A. Prevention of perinatal group B streptococcal disease. Revised guidelines from CDC. MMWR Recomm Rep. 2002 Aug 16;51(RR-11):1-22.
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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.
Irja Lutsar, MD, PhD study chair
University of Tartu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Onset Neonatal Sepsis, run by University of Tartu at 2 sites in Estonia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Estonia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00487019, which also lists 1 linked publication.
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 29 May 2008.