EndotoxemiaNCT00197899
Low-Dose Endotoxemia and the Acute Phase Response
A study testing E. Coli endotoxin in people with Endotoxemia and Sepsis, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpuse of this study is to examine the acute phase respons when different doses of E. Coli Endotoxin is injected in healty volunters. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Endotoxemia, Sepsis
- What is being tested?
- E. Coli endotoxin
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Mar 2004to Jan 2005
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Infection 14 days prior to the trial Regular medication Present and /or former heart disease -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Intensive Care
Copenhagen, Copenhagen County, 2730
About this study
The purpuse of this study is to examine the acute phase respons when different doses of E. Coli Endotoxin is injected in healty volunters.
- Conditions
- Endotoxemia, Sepsis
- Being tested
- E. Coli endotoxin
- Medical subject headings
- Endotoxemia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. Coli endotoxinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndotoxemiaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bente K Pedersen, MD, DMSc, Study chair, Department of Infectious Diseases 7641, University Hospital of Copenhagen, H:S RigshospitaletDorthe H Olsen, MD, Principal investigator, Department of Intensive Care, Herlev University HospitalDorthe H Olsen, DM, Study director, Department of Intensive Care, Herlev University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197899
- Sponsor's protocol ID
- KA 04015
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 13 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Endotoxemia and the Acute Phase Response
- ClinicalTrials.gov ID
- NCT00197899
- Acronym / sponsor ID
- KA 04015
- Conditions
- Endotoxemia, Sepsis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Jan 2005
- First posted
- 20 Sep 2005 (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 purpuse of this study is to examine the acute phase respons when different doses of E. Coli Endotoxin is injected in healty volunters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Infection 14 days prior to the trial Regular medication Present and /or former heart disease -
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 |
|---|---|---|
| E. Coli endotoxin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2005.
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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.
Bente K Pedersen, MD, DMSc study chair
Department of Infectious Diseases 7641, University Hospital of Copenhagen, H:S Rigshospitalet
Dorthe H Olsen, MD principal investigator
Department of Intensive Care, Herlev University Hospital
Dorthe H Olsen, DM study director
Department of Intensive Care, Herlev University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E. Coli endotoxin in people with Endotoxemia and Sepsis, run by Herlev Hospital at 1 site in Denmark.
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 0 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 13 Dec 2005. 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 Denmark. 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?
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?
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 13 Dec 2005.