NCT01133834

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 15, 2011

Status Verified

February 1, 2003

Enrollment Period

8.3 years

First QC Date

May 27, 2010

Last Update Submit

June 14, 2011

Conditions

Meningococcemia

Keywords

meningococcal diseasecytokines

Outcome Measures

Primary Outcomes (1)

  • shock

    low blood pressure

    24 hours

Secondary Outcomes (2)

  • acute kidney injury

    3 days

  • disseminated intravascular coagulation

    24 hours

Study Arms (1)

patients with meningococcemia

Patients with meningococcemia admitted at the Intensive Care Unit

Eligibility Criteria

Age6 Months - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted at the Intensive Care Unit of the Instituto de Infectologia Emílio Ribas

You may qualify if:

  • clinical diagnostic of meningococcal disease

You may not qualify if:

  • no meningococcal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo General Hospital - LIM-12 and LIM-56

São Paulo, São Paulo, 01246-903, Brazil

Location

Biospecimen

Retention: NONE RETAINED

blood sample cerebral spinal fluid

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Antonio C Seguro, MD, PhD

    Hospital das Clínicas USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 31, 2010

Study Start

March 1, 2003

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 15, 2011

Record last verified: 2003-02

Locations

BR(1)