Pathogen ResistanceNCT03077100
Identification of Pathogens in the Neonatal Intensive Care Unit (NICU)
An observational study of Pathogen Resistance, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
To aim of this study is to identify the pathogens and their distribution in the NICU and to determine whether empirical antibiotics are suitable for the treatment of sepsis in the unit. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Pathogen Resistance
- What is being tested?
- Laboratory identification of positive cultures
- How many people
- 2,000 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2017to Mar 2018
- 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 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Newborns hospitalized in NICU with positive cultures
Who may be able to join
- Newborns with positive cultures
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Samah Abu-Fanni, MD contact
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Samah Abu-Fanni, MD, samah_af88@hotmail.com
Samah Abu-Fanni, MD
About this study
Official title: Identification of Pathogens and Their Antibiogram in the Neonatal Intensive Care Unit (NICU)
To aim of this study is to identify the pathogens and their distribution in the NICU and to determine whether empirical antibiotics are suitable for the treatment of sepsis in the unit.
- Conditions
- Pathogen Resistance
- Being tested
- Laboratory identification of positive cultures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory identification of positive culturesOther
Laboratory identification of positive cultures
| Study group | Role | What they receive |
|---|---|---|
| Newborns with positive cultures | Positive cultures of newborns hospitalized in the NICU in the past 5 years will undergo laboratory examination and identification Receives: Other: Laboratory identification of positive cultures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiogram
Positive cultures will be examined using an antibiogram and pathogens will be identified
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathogen ResistanceStudies 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michael Feldman, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077100
- Sponsor's protocol ID
- HYMC-0001-17
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Pathogens and Their Antibiogram in the Neonatal Intensive Care Unit (NICU)
- ClinicalTrials.gov ID
- NCT03077100
- Acronym / sponsor ID
- HYMC-0001-17
- Conditions
- Pathogen Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 10 Mar 2017 (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.
To aim of this study is to identify the pathogens and their distribution in the NICU and to determine whether empirical antibiotics are suitable for the treatment of sepsis in the unit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns with positive cultures | – | Other: Laboratory identification of positive culturesPositive cultures of newborns hospitalized in the NICU in the past 5 years will undergo laboratory examination and identification |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns hospitalized in NICU with positive cultures
Key inclusion criteria (1 listed)
- Newborns with positive cultures
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Laboratory identification of positive culturesLaboratory identification of positive cultures | Other | Newborns with positive cultures |
Primary outcome
Antibiogram
Time frame: One year
Positive cultures will be examined using an antibiogram and pathogens will be identified
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis
Sepsis
Enrolling by invitationObservational study
Prospective Study of Multi-centers Exploring the Difference of Clinical Impact by Using Respiratory Pathogen ID/AMR Panel (RPIP) Versus Untarget Metagenomic Next-generation Sequencing (mNGS) and Multiplex PCR in Pathogen Identification of Pneumonia Patients in Intensive Care Unit
Respiratory Pathogens
RecruitingObservational study
Chinese PICU Collaborative Network on Pathogens and Drug Resistance of Severe Infections
Severe Infection
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.
Samah Abu-Fanni, MD contact
Michael Feldman, MD principal investigator
Hillel Yaffe Medical Center
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 Pathogen Resistance, run by Hillel Yaffe Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 10 Mar 2017. 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 Israel. 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 Samah Abu-Fanni, MD (samah_af88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiogram (time frame: One year). 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 10 Mar 2017.