|
Main
|
|
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: |
|
|
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
|
|
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
|
|