SepsisPhase 2NCT00252915
Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock
A Phase 2 study testing GM-CSF (verum) in people with Sepsis, run by Charite University, Berlin, Germany.
Trial summary
There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- GM-CSF (verum)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Apr 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe sepsis or septic shock,
- Presence of infection,
- 2 SIRS criteria,
- Acute organ dysfunction,
- Immunoparalysis,
- Informed consent
Who cannot join
- Pregnancy,
- Known allergies to study medication or components,
- Moribound patient,
- Autoimmune disease,
- HIV-infection,
- Acute MI or pulmonary embolism,
- Cpr during last 72 hours,
- Patients who participate in a different clinical study
About this study
Official title: Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock: a Prospective, Randomised, Double-blind, Placebo-controlled Study
There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.
Read the detailed description
GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patinets with severe sepsis and septic shock.
- Conditions
- Sepsis
- Being tested
- GM-CSF (verum)
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSF (verum)Biological
sagramostim
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | GM-CSF therapy Receives: Biological: GM-CSF (verum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9
Measured: after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Hans-Dieter Volk, MD, Study chair, Charite University, Berlin, GermanyJoerg C Schefold, MD, Principal investigator, Charite University MedicineChristian Meisel, MD, Principal investigator, Charite University Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252915
- Sponsor's protocol ID
- GM-CSF-1
- Status last verified
- Jul 2009
- First submitted
- 14 Nov 2005
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Meisel C, Schefold JC, Pschowski R, Baumann T, Hetzger K, Gregor J, Weber-Carstens S, Hasper D, Keh D, Zuckermann H, Reinke P, Volk HD. Granulocyte-macrophage colony-stimulating factor to reverse sepsis-associated immunosuppression: a double-blind, randomized, placebo-controlled multicenter trial. Am J Respir Crit Care Med. 2009 Oct 1;180(7):640-8. doi: 10.1164/rccm.200903-0363OC. Epub 2009 Jul 9.
PubMed 19590022
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock: a Prospective, Randomised, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00252915
- Acronym / sponsor ID
- GM-CSF-1
- Conditions
- Sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Nov 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Nov 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.
There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.
Detailed description
GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patinets with severe sepsis and septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Biological: GM-CSF (verum)GM-CSF therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Severe sepsis or septic shock,
- Presence of infection,
- 2 SIRS criteria,
- Acute organ dysfunction,
- Immunoparalysis,
Key exclusion criteria (8 listed)
- Pregnancy,
- Known allergies to study medication or components,
- Moribound patient,
- Autoimmune disease,
- HIV-infection,
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 |
|---|---|---|
| GM-CSF (verum)sagramostim | Biological | Verum |
Primary outcome
reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9
Time frame: after therapy
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 26 May 2011.
- Derived from this study: PubMed 19590022Meisel C, Schefold JC, Pschowski R, Baumann T, Hetzger K, Gregor J, Weber-Carstens S, Hasper D, Keh D, Zuckermann H, Reinke P, Volk HD. Granulocyte-macrophage colony-stimulating factor to reverse sepsis-associated immunosuppression: a double-blind, randomized, placebo-controlled multicenter trial. Am J Respir Crit Care Med. 2009 Oct 1;180(7):640-8. doi: 10.1164/rccm.200903-0363OC. Epub 2009 Jul 9.
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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.
Hans-Dieter Volk, MD study chair
Charite University, Berlin, Germany
Joerg C Schefold, MD principal investigator
Charite University Medicine
Christian Meisel, MD principal investigator
Charite University Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-CSF (verum) in people with Sepsis, run by Charite University, Berlin, Germany.
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 6 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: finished, as of the sponsor's last update on 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9 (time frame: after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00252915, which also lists 1 linked publication.
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 26 May 2011.