Nosocomial Neonatal SepsisPhase 3NCT01867138
Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin
A Phase 3 study testing Cefazolin, Vancomycin and Amikacin in people with Nosocomial Neonatal Sepsis, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial sepsis probably caused by Coagulase-negative staphylococcus. Read more about this study
- Who is it for?
- Ages 4 days to 4 months
- Conditions the study is for
- Nosocomial Neonatal Sepsis
- What is being tested?
- Cefazolin, Vancomycin and Amikacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2007to Jan 2011
- Phase
- Phase 3
- 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 4 days to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn infants older than three days of life with suspected bacterial sepsis and according to attending physicians, with an indication for initial treatment with vancomycin and at least one blood culture taken prior to receiving the antimicrobial treatment.
Who cannot join
- previous treatment with vancomycin during the week before,
- infants referred from other hospitals and, upon admission, were being treated with antibiotics.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Buenos Aires, Capital, 1181
About this study
Official title: Clinical Outcome of Newborn Infants With Suspected Nosocomial Coagulase-negative Staphylococcal Sepsis Treated With Cefazolin or Vancomycin. A Non-inferiority, Randomized, Controlled Trial
The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial sepsis probably caused by Coagulase-negative staphylococcus.
The investigators hypothesized that newborn infants with the presumptive diagnosis of nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome not inferior to that of those treated with vancomycin.
- Conditions
- Nosocomial Neonatal Sepsis
- Being tested
- Cefazolin, Vancomycin, Amikacin
- Keywords
- Coagulase negative staphylococcus, nosocomial neonatal sepsis, cefazolin, vancomycin, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
VancomycinDrug
AmikacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin group | Experimental | Initial empirical treatment with cefazolin and amikacin Receives: Drug: Cefazolin; Drug: Amikacin |
| Vancomycin | Active comparator | Initial empirical treatment with vancomycin and amikacin Receives: Drug: Vancomycin; Drug: Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome of infants
Examination of each newborn infant by two of the investigators independently to establish whether the clinical outcome was adequate or inadequate. In order to achieve greater objectivity, the clinical examination was performed using the following criteria:
Adequate: when the newborn infant had normal clinical parameters, a good general condition, appropriate tolerance to gastric feeding, normal temperature , negative blood and CSF cultures, and normalized results for the lab tests performed at the onset of the treatment.
Inadequate: when one or more of the following were present: clinical course with persistence of any of the signs of sepsis, positive blood or CSF cultures after 72 hours from the onset of treatment, persistence of abnormal lab tests, and death by sepsis.
Measured: Seven to ten days after starting antibiotics
Secondary outcomes (1)
Percentage of infants initially assigned to cefazolin group that were switched to vancomycin.
Patients with an inadequate 72 hour response to cefazolin were crossed over to receive vancomycin. The adjudication of response at 72 hours was delineated in a well-defined algorithm. To minimize bias, the final decision to switch treatments, initiated by the pediatrician in charge, required secondary review and agreement of another participating investigator as well as the attending NICU physician.
Measured: Within 72 hours of starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study startMar 2007
- Primary completionAug 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Ceriani Cernadas M.D., Hospital Italiano de Buenos Aires
- Investigators
- Jose M Cernadas, M.D., Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867138
- Sponsor's protocol ID
- 563
- Status last verified
- May 2013
- First submitted
- 29 May 2013
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Newborn Infants With Suspected Nosocomial Coagulase-negative Staphylococcal Sepsis Treated With Cefazolin or Vancomycin. A Non-inferiority, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01867138
- Acronym / sponsor ID
- 563
- Conditions
- Nosocomial Neonatal Sepsis
- Keywords
- Coagulase negative staphylococcus, nosocomial neonatal sepsis, cefazolin, vancomycin, newborn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Jun 2013 (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.
The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial sepsis probably caused by Coagulase-negative staphylococcus.
The investigators hypothesized that newborn infants with the presumptive diagnosis of nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome not inferior to that of those treated with vancomycin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin group | Experimental | Drug: Cefazolin, Drug: AmikacinInitial empirical treatment with cefazolin and amikacin |
| Vancomycin | Active comparator | Drug: Vancomycin, Drug: AmikacinInitial empirical treatment with vancomycin and amikacin |
Who may qualify
- Ages
- 4 days to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborn infants older than three days of life with suspected bacterial sepsis and according to attending physicians, with an indication for initial treatment with vancomycin and at least one blood culture taken prior to receiving the antimicrobial treatment.
Key exclusion criteria (2 listed)
- previous treatment with vancomycin during the week before,
- infants referred from other hospitals and, upon admission, were being treated with antibiotics.
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 |
|---|---|---|
| Cefazolin | Drug | Cefazolin group |
| Vancomycin | Drug | Vancomycin |
| Amikacin | Drug | Cefazolin group, Vancomycin |
Primary outcome
Clinical outcome of infants
Time frame: Seven to ten days after starting antibiotics
Examination of each newborn infant by two of the investigators independently to establish whether the clinical outcome was adequate or inadequate. In order to achieve greater objectivity, the clinical examination was performed using the following criteria: Adequate: when the newborn infant had normal clinical parameters, a good general condition, appropriate tolerance to gastric feeding, normal temperature , negative blood and CSF cultures, and normalized results for the lab tests performed at the onset of the treatment. Inadequate: when one or more of the following were present: clinical course with persistence of any of the signs of sepsis, positive blood or CSF cultures after 72 hours from the onset of treatment, persistence of abnormal lab tests, and death by sepsis.
1 secondary outcome
Percentage of infants initially assigned to cefazolin group that were switched to vancomycin.
Time frame: Within 72 hours of starting treatment
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 3 Jun 2013.
Related trials for Nosocomial Neonatal Sepsis
Recruiting
Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
Infection, Bacterial, Infection Prevention
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.
Jose M Cernadas, M.D. principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefazolin, Vancomycin and Amikacin in people with Nosocomial Neonatal Sepsis, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 2 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 3 Jun 2013. 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 Argentina. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Clinical outcome of infants (time frame: Seven to ten days after starting antibiotics). 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 3 Jun 2013.