Status:
TERMINATED
IHPOTOTAM : Induced HyPOthermia TO Treat Adult Meningitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Bacterial Meningitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Bacterial meningitis is a severe infection of the envelope which surrounds the brain. It is sometimes responsible for a cerebral oedema mattering with a loss of consciousness (coma). The usual treatme...
Detailed Description
Investigational procedure: This study evaluates the impact of mild induced hypothermia (32-34°C) during 48 hours followed by passive rewarming according to recommendations described in appendix. All ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subject is 18 years of age or older
- Clinically suspected community-acquired bacterial meningitis (More than 100 white blood cells in CSF and a glucose CSF/Blood ratio of 1/3 or less, or a CSF protein level above 2,2 g/L.)
- Presence of micro-organisms on CSF Gram's stain examination
- Positive soluble antigen or PCR for S. pneumoniae or N. meningitides
- Positive CSF cultures
- Score on Glasgow Coma Score \< 8
- Patient received appropriate antimicrobial therapy (according to recommendations)
- If present, legally acceptable representative has provided written and dated informed consent to participate in the study.
- EXCLUSION CRITERIA:
- Glasgow Coma Score \< 8 for more than 12 hours
- Patients with HIV positivity: positive cryptococcal antigen in blood or CSF; Cerebral abscess
- pregnancy
- Subject has been designated as "not full support", "do not resuscitate" or equivalent status which prohibits the use of life supporting interventions thereby limiting options available
- Subject admitted for a clinical situation in which induced hypothermia is recommended
- Purpura fulminancy, defined as septic shock with extensive necrotizing purpura and disseminated intravascular coagulation.
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00774631
Start Date
March 1 2009
End Date
July 1 2012
Last Update
September 17 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Bichat Claude Bernard
Paris, France, 75018