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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: PACTR
Last refreshed on: 29 April 2013
Main ID:  PACTR201111000338157
Date of registration: 11/11/2011
Primary sponsor: Liverpool School of Tropical Medicine
Public title: Clinical care bundles for adult meningitis in Malawi
Scientific title: Early Goal Directed Therapy for adult meningitis in Malawi
Date of first enrolment: 2012-01-02
Target sample size: 200
Recruitment status: Not yet recruiting
URL:  HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201111000338157
Study type:  interventional
Study design:  Single group: all participants receive same intervention throughout study,
Non-randomised,
 
Countries of recruitment
South Africa
Contacts
Name: Emma  Wall
Address:  MLW PO Box 30096 Chichiri 3 Blantyre Malawi
Telephone: +265991814283
Email: emma.wall@liv.ac.uk
Affiliation: 
Name: Tamara  Chipasula
Address:  MLW PO Box 30096 Chichiri 3 Blantyre Malawi
Telephone: +2651876444
Email: tchipasula@mlw.medcol.mw
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Primary inclusion criteria:
Fever plus one of
headache
confusion
coma
seizures

Secondary inclusion criteria:
CSF white cell count b50 cells per mm2, irrespective of HIV status, or visible bacteria in the counting chamber or on Gram's stain

Exclusion criteria: Primary exclusion criteria:
Known terminal illness
Cerebral malaria
Head trauma

Secondary exclusion criteria
CSF culture stain or antigen positive for an organim known to cause fungal or mycobacterial menignitis
CSF WCC `50% neutrophils


Age minimum: 12 Year
Age maximum: 100 Year
Gender: Both
Health Condition(s) or Problem(s) studied

Bacterial meningitis
Intervention(s)
Primary Outcome(s)
Percentage of clinical targets achieved by the care bundle
Secondary Outcome(s)
Mortality
Neurological disability
Seizure frequency
Secondary ID(s)
LSTM 10.70 COMREC P.09/10/980
Source(s) of Monetary Support
Wellcome Trust
Secondary Sponsor(s)
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