Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201111000338157 Date of Approval: 11/11/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical care bundles for adult meningitis in Malawi
Official scientific title Early Goal Directed Therapy for adult meningitis in Malawi
Brief summary describing the background and objectives of the trial Bacterial meningitis in Africa in adults has a mortality of 54% and adjunctive treatments tested have not improved outcome. This study will test if a clinical care bundle, delivered with early goal directed targets is possible in Africa and if it will reduce mortality. Primnary outcome: Percentage of targets achieved Secondary outcome: mortality, neurological disability
Type of trial CCT
Acronym (If the trial has an acronym then please provide) BAM
Disease(s) or condition(s) being studied Bacterial meningitis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/01/2012
Actual trial start date
Anticipated date of last follow up 20/12/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
LSTM 10.70 COMREC P.09/10/980
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clinical care bundle 6 hours early antibiotics, glucose, oxygen, head elevation, seizure treatment 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary inclusion criteria: Fever plus one of headache confusion coma seizures Secondary inclusion criteria: CSF white cell count >50 cells per mm2, irrespective of HIV status, or visible bacteria in the counting chamber or on Gram's stain 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 12 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/11/2010 LSTM
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/01/2011 COMREC
Ethics Committee Address
Street address City Postal code Country
College of Medicine, Private bag 360,Chichiri 3 Blantyre Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of clinical targets achieved by the care bundle Hourly for 6 hours of care bundle delivery
Secondary Outcome Mortality Day 10 discharge from hospital Day 40 follow up post discharge
Secondary Outcome Neurological disability Day 10 discharge from hospital Day 40 follow up post discharge
Secondary Outcome Seizure frequency Day 10 discharge from hospital Day 40 follow up post discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Queen Elizabeth Central Hospital Ginnery Corner Blantyre Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Professor Stephen Gordon LSTM, Pembroke Place Liverpool L3 5QA United Kingdom
Professor Mike Levin Imperial College London United Kingdom
Dr Dean Everett MLW Blanytre Malawi
Professor Theresa Allain Queen Elizabeth Central Hospital Blantyre Malawi
Dr Mulinda Nyirenda Queen Elizabeth Central Hospital Blantyre Malawi
Dr John Chipolombwe Queen Elizabeth Central Hospital Blantyre Malawi
Brigitte Denis MLW Blantyre Malawi
Dr Brian Faragher LSTM Liverpool United Kingdom
Professor Tom Solomon University of Liverpool Liverpool L69 3GF Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emma Wall emma.wall@liv.ac.uk +265991814283 MLW PO Box 30096, Chichiri 3
City Postal code Country Position/Affiliation
Blantyre Malawi
Role Name Email Phone Street address
Public Enquiries Tamara Chipasula tchipasula@mlw.medcol.mw +2651876444 MLW PO Box 30096 Chichiri 3
City Postal code Country Position/Affiliation
Blantyre Malawi
Role Name Email Phone Street address
Scientific Enquiries Emma Wall emma.wall@liv.ac.uk +265991814283 MLW PO Box 30096 Chichiri 3
City Postal code Country Position/Affiliation
Blantyre Malawi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information