IHPOTOTAM : Induced HyPOthermia TO Treat Adult Meningitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00774631
• Date of registration: 16/10/2008
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: IHPOTOTAM : Induced HyPOthermia TO Treat Adult Meningitis IHPOTOTAM
• Scientific title: Mild Induced Hypothermia to Treat Severe Community Acquired Meningitis in Adults Admitted to Intensive Care Unit
• Date of first enrolment: March 2009
• Target sample size: 98
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00774631
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: MOURVILLIER Bruno, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bacterial Meningitis

Intervention(s)

Procedure: Mild induced hypothermia (32-34°C)

Procedure: local recommendations and guidelines

Primary Outcome(s)

Proportion of patients with unfavorable outcome (defined as score on Glasgow outcome Scale < 5) at 3 months after admission. [Time Frame: 3 months]

Secondary Outcome(s)

Prevalence of status EPILEPTISIS [Time Frame: 6 months]

Score on GOS at ICU discharge and 6 months after admission [Time Frame: 6 months]

ICU length of stay [Time Frame: 6 months]

Mortality (assessed on day 14 after admission, day 28, total in-hospital mortality, and at 3 and 6 months) [Time Frame: 6 months]

Neurological examination at discharge and 6 months after admission [Time Frame: 6 months]

Neuropsychological outcome at 6 months in a subset of centres; patient will be tested with a neuropsychological test battery described previously [Time Frame: 6 months]

MRC score on ICU discharge [Time Frame: 3 months]

Potential hypothermia related side effects as cardiac arrhythmia, electrolyte balance, hyperglycemia, bleeding, acute pancreatitis (see definitions further). [Time Frame: 6 months]

Prevalence of infections (aspiration pneumonia and nosocomial infections) [Time Frame: 6 months]

Secondary ID(s)

P 060217

AOM 06 038

Source(s) of Monetary Support

Please refer to primary and secondary sponsors