MeningococcemiaNCT01133834
Correlation Between Cytokines and the Severity of Meningococcal Disease
An observational study of Meningococcemia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Objectives: Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. Read more about this study
- Who is it for?
- Ages 6 months to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcemia
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2003to Jun 2011
- 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 6 months to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients admitted at the Intensive Care Unit of the Instituto de Infectologia Emílio Ribas
Who may be able to join
- clinical diagnostic of meningococcal disease
Who cannot join
- no meningococcal disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo General Hospital - LIM-12 and LIM-56
São Paulo, São Paulo, 01246-903
About this study
Official title: Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease
Objectives:
Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD, as well as relate the level of these cytokines to severity of MD.
Read more
Design:
Prospective, nonrandomized study.
Setting:
Tertiary referral intensive care unit.
Patients:
Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.
Read the detailed description
Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD:
IL -4; IL-6; IL-10 and interferon alfa, as well as relate the level of these cytokines to severity of MD, evaluated by occurrence of shock, acute renal failure, disseminated intravascular coagulation and survival.
Design: Prospective, nonrandomized study. Setting: Tertiary referral intensive care unit. Patients: Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.
Measurements and Main Results: in process Conclusions: in process
- Conditions
- Meningococcemia
- Keywords
- meningococcal disease, cytokines
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with meningococcemia | Patients with meningococcemia admitted at the Intensive Care Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
shock
low blood pressure
Measured: 24 hours
Secondary outcomes (2)
acute kidney injury
elevation of serum creatinine levels
Measured: 3 days
disseminated intravascular coagulation
plaquetopenia, coagulopathy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMar 2003
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningococcemiaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Infectologia Emílio Ribas
- Investigators
- Antonio C Seguro, MD, PhD, Principal investigator, Hospital das Clínicas USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133834
- Sponsor's protocol ID
- meningococcemia
- Status last verified
- Feb 2003
- First submitted
- 27 May 2010
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease
- ClinicalTrials.gov ID
- NCT01133834
- Acronym / sponsor ID
- meningococcemia
- Conditions
- Meningococcemia
- Keywords
- meningococcal disease, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Instituto de Infectologia Emílio Ribas
- Study start
- Mar 2003
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 May 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.
Objectives:
Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD, as well as relate the level of these cytokines to severity of MD.
Design:
Prospective, nonrandomized study.
Setting:
Tertiary referral intensive care unit.
Patients:
Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.
Detailed description
Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD:
IL -4; IL-6; IL-10 and interferon alfa, as well as relate the level of these cytokines to severity of MD, evaluated by occurrence of shock, acute renal failure, disseminated intravascular coagulation and survival.
Design: Prospective, nonrandomized study. Setting: Tertiary referral intensive care unit. Patients: Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.
Measurements and Main Results: in process Conclusions: in process
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with meningococcemia | – | –Patients with meningococcemia admitted at the Intensive Care Unit |
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted at the Intensive Care Unit of the Instituto de Infectologia Emílio Ribas
Key inclusion criteria (1 listed)
- clinical diagnostic of meningococcal disease
Key exclusion criteria (1 listed)
- no meningococcal disease
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
shock
Time frame: 24 hours
low blood pressure
2 secondary outcomes
acute kidney injury
Time frame: 3 days
disseminated intravascular coagulation
Time frame: 24 hours
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 15 Jun 2011.
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.
Antonio C Seguro, MD, PhD principal investigator
Hospital das Clínicas USP
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 Meningococcemia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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: finished, as of the sponsor's last update on 15 Jun 2011. 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 Brazil. 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 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?
shock (time frame: 24 hours). 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 15 Jun 2011.