InflammationNCT03626870
Effects of Resistin on Neutrophil Function
An observational study of Inflammation, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
To assess the effect of resistin on neutrophil migration and intracellular bacterial killing Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Sep 2019
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all healthy volunteer adults
Who may be able to join
- age ≥ 18
- gender: male or female
Who cannot join
- Adults who are unable to provide informed consent themselves
- History of chronic kidney disease as defined by estimated glomerular filtration rate (GFR) <60 ml/min prior to cardiogenic shock
- Patients with hematologic malignancies
- Pregnant women
- Patient/surrogate is not fluent in English
- Long-term immunosuppressive therapy
- Prisoner
- Patients on pre-existing continuous reno-renal therapy (CRRT) or intermittent hemodialysis (IHD
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
To assess the effect of resistin on neutrophil migration and intracellular bacterial killing
- Conditions
- Inflammation
- Medical subject headings
- Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
intracellular bacterial killing, assessed by number of colonies of bacterial growth following neutrophil exposure to bacteria and resistin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Why it stopped: does not meet criteria for clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Bonavia, Penn State Health Milton S Hershey Medical Center
- Investigators
- Anthony Bonavia, MD, Principal investigator, Penn State Milton S Hershey Med Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626870
- Sponsor's protocol ID
- STUDY00010357
- Status last verified
- Mar 2023
- First submitted
- 3 Aug 2018
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistin on Neutrophil Function
- ClinicalTrials.gov ID
- NCT03626870
- Acronym / sponsor ID
- STUDY00010357
- Conditions
- Inflammation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: does not meet criteria for clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 13 Aug 2018 (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 assess the effect of resistin on neutrophil migration and intracellular bacterial killing
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all healthy volunteer adults
Key inclusion criteria (2 listed)
- age ≥ 18
- gender: male or female
Key exclusion criteria (8 listed)
- Adults who are unable to provide informed consent themselves
- History of chronic kidney disease as defined by estimated glomerular filtration rate (GFR) <60 ml/min prior to cardiogenic shock
- Patients with hematologic malignancies
- Pregnant women
- Patient/surrogate is not fluent in English
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
intracellular bacterial killing, assessed by number of colonies of bacterial growth following neutrophil exposure to bacteria and resistin
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Anthony Bonavia, MD principal investigator
Penn State Milton S Hershey Med Ctr
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 Inflammation, run by Milton S. Hershey Medical Center at 1 site in United States.
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 8 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: withdrawn, as of the sponsor's last update on 10 Dec 2024. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
intracellular bacterial killing, assessed by number of colonies of bacterial growth following neutrophil exposure to bacteria and resistin (time frame: 6 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 10 Dec 2024.