InfectionsPhase 1NCT01064986
The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers
A Phase 1 study testing Endotoxin, Lipopolysaccharide, LPS, Endotoxin, Lipopolysaccharide, LPS /Epinephrine and Hydrocortisone in people with Infections, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Corticosteroids are substances produced by the adrenal gland to help the body fight against infection or injury. Hydrocortisone is a man-made form of this substance. Endotoxin is a man-made substance, which causes the body to "mimic" sickness(fever,chills,and achiness)for a few hours. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Endotoxin, Lipopolysaccharide, LPS, Endotoxin, Lipopolysaccharide, LPS /Epinephrine and Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2012
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General good health as demonstrated by medical history, physical\& laboratory tests
- Age between 18 and 40 years
- Written informed consent prior to the performance of any study related procedures
Who cannot join
- History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
- Any medication taken in past 48 hrs (except birth control)
- Recent history of alcohol or drug abuse
- Unable to provide written informed consent
- Exposure to any experimental agent or procedure within 30 days of study
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Corticosteroids are substances produced by the adrenal gland to help the body fight against infection or injury. Hydrocortisone is a man-made form of this substance. Endotoxin is a man-made substance, which causes the body to "mimic" sickness(fever,chills,and achiness)for a few hours. This study is designed to give hydrocortisone before and after Endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by the Endotoxin.
Read the detailed description
The body's immune response to injury otr infection is very complex. Immune cell activity, the release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA) and/or the body's "instructions" for making proteins (Ribonucleic Acid or RNA) may effect the body's clinical response to a stress such as an infection.Hydrocortisone is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. Endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. This study is designed to give hydrocortisone before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.In addition, this study may determine whether any of the above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to hydrocortisone and/or endotoxin. This will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.
- Conditions
- Infections
- Being tested
- Endotoxin, Lipopolysaccharide, LPS, Endotoxin, Lipopolysaccharide, LPS /Epinephrine, Placebo, Hydrocortisone
- Keywords
- Immune System
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotoxin, Lipopolysaccharide, LPSBiological
Also called Sodium Chloride Solution
Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (~5 minutes)
Endotoxin, Lipopolysaccharide, LPS /EpinephrineBiological
Also called Solu-Cortef
Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min)
PlaceboBiological
Saline vehicle (placebo)
HydrocortisoneBiological
Hydrocortisone
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | IV Endotoxin plus saline vehicle (placebo) Receives: Biological: Endotoxin, Lipopolysaccharide, LPS; Biological: Placebo |
| B | Active comparator | IV Endotoxin plus IV hydrocortisone Receives: Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine; Biological: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological, Hematological, Immunological Responses
Measured: 0.5-24 hrs post Endotoxin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siobhan Corbett, MD, Principal investigator, Rutgers-RWJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064986
- Sponsor's protocol ID
- 0220070126
- Other IDs
- NIH/DHHS
- Status last verified
- May 2014
- First submitted
- 5 Feb 2010
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers
- ClinicalTrials.gov ID
- NCT01064986
- Acronym / sponsor ID
- 0220070126
- Conditions
- Infections
- Keywords
- Immune System
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Feb 2010 (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.
Corticosteroids are substances produced by the adrenal gland to help the body fight against infection or injury. Hydrocortisone is a man-made form of this substance. Endotoxin is a man-made substance, which causes the body to "mimic" sickness(fever,chills,and achiness)for a few hours. This study is designed to give hydrocortisone before and after Endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by the Endotoxin.
Detailed description
The body's immune response to injury otr infection is very complex. Immune cell activity, the release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA) and/or the body's "instructions" for making proteins (Ribonucleic Acid or RNA) may effect the body's clinical response to a stress such as an infection.Hydrocortisone is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. Endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. This study is designed to give hydrocortisone before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.In addition, this study may determine whether any of the above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to hydrocortisone and/or endotoxin. This will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Biological: Endotoxin, Lipopolysaccharide, LPS, Biological: PlaceboIV Endotoxin plus saline vehicle (placebo) |
| B | Active comparator | Biological: Endotoxin, Lipopolysaccharide, LPS /Epinephrine, Biological: HydrocortisoneIV Endotoxin plus IV hydrocortisone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- General good health as demonstrated by medical history, physical\& laboratory tests
- Age between 18 and 40 years
- Written informed consent prior to the performance of any study related procedures
Key exclusion criteria (6 listed)
- History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
- Any medication taken in past 48 hrs (except birth control)
- Recent history of alcohol or drug abuse
- Unable to provide written informed consent
- Exposure to any experimental agent or procedure within 30 days of study
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 |
|---|---|---|
| Endotoxin, Lipopolysaccharide, LPSAlso: Sodium Chloride SolutionClinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (~5 minutes) | Biological | A |
| Endotoxin, Lipopolysaccharide, LPS /EpinephrineAlso: Solu-CortefClinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min) | Biological | B |
| PlaceboSaline vehicle (placebo) | Biological | A |
| HydrocortisoneHydrocortisone | Biological | B |
Primary outcome
Physiological, Hematological, Immunological Responses
Time frame: 0.5-24 hrs post Endotoxin administration
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 22 May 2014.
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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.
Siobhan Corbett, MD principal investigator
Rutgers-RWJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endotoxin, Lipopolysaccharide, LPS, Endotoxin, Lipopolysaccharide, LPS /Epinephrine and Hydrocortisone in people with Infections, run by Rutgers, The State University of New Jersey 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 3 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: finished, as of the sponsor's last update on 22 May 2014. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Physiological, Hematological, Immunological Responses (time frame: 0.5-24 hrs post Endotoxin administration). 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 22 May 2014.