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Main
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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. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR2009110001673419 |
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Date of registration:
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22/10/2009 |
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Primary sponsor: |
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Public title:
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PREDINAM
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Scientific title:
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TBscore and suPAR used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial |
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Date of first enrolment:
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Target sample size:
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Recruitment status: |
Temporary halt or suspension |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2009110001673419 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Simple randomisation using a radomisation table created by a computer software program,
Allocation was determined by the holder of the sequence who is situated off site,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Frauke
Rudolf |
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Address:
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apartado 861
1004
Bissau Codex
Guinea-Bisseu |
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Telephone:
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+ 245 6895169 |
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Email:
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frauke.rudolf@ki.au.dk |
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Affiliation:
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MD PhD student |
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Name:
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Christian
Wejse |
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Address:
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Department of infectious diseases Skejby sygehus, Aarhus University Hospital Brendstrupg?rdsvej
8200
?rhus N
Denmark |
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Telephone:
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Phone: +45-89498492 |
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Email:
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wejse@dadlnet.dk |
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Affiliation:
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PhD/Supervisor |
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Key inclusion & exclusion criteria
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Inclusion criteria: - adults (b 15 years)
- At least one symptom indicating possible TB: 3 weeks of cough, sputum production or weight loss.
- Residents or long-term guests of Bandim I, Bandim II, Belem, Mindara and Cuntum.
Exclusion criteria: None
Age minimum:
15 Year
Age maximum:
100 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
Tuberculosis
null
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Primary Outcome(s)
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12 month overall mortality in the high risk group with TBscore?8 or suPAR?4
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Secondary Outcome(s)
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Weight gain, haemoglobin increase, TBscore/suPAR decrease
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Secondary ID(s)
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Ulandsprojekt Sagsnr. 0907691
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Source(s) of Monetary Support
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Frimodt-Heineke Fonden
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A P M?ller fonden (l?gev. Fremme)
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Jacob og Olga Madsen Fond
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EDCTP
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Klinisk Forskningscenter Hvidovre
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?rhus Universitets Forskningsfond
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