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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: www.pactr.org

Trial no.: PACTR2009110001673419 Date registered: 2009/10/22
TRIAL DESCRIPTION
Public title PREDINAM
Official scientific title TBscore and suPAR used to PREDict and INtervene Against high Mortality (PREDINAM) - a randomised trial
Brief summary describing the background
and objectives of the trial
We hypothesize that in a limited-resource-setting with , it is possible to reduce mortality in TB and aTBneg (assumed TB negative) patients by focussing on patients needing most attention. Our objective is to reduce mortality among individuals with symptoms of TB infection using simple tools (TBscore and suPAR)to provide individualized treatment. If TB mortality can be reduced with simple measures available in high burden settings, this will be a major step forward in the battle against TB.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PREDINAM
Disease(s) or condition(s) being studied HIV/AIDS , Tuberculosis ,
Purpose of the trial Diagnosis
Anticipated trial start date
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 590   
Recruitment status Temporary halt or suspension
Secondary Ids Issuing authority/Trial register Links to Secondary ID
Ulandsprojekt Sagsnr. 0907691 Den Centrale Videnskabsetiske Komité (CVK)
Ulandsprojekt Sagsnr. 0907691 Den Centrale Videnskabsetiske Komité (CVK)

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
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 Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Normal treatment (TB patients) Patients in this group will be treated according to the decision of the consulting doctor at the health center. 115
Experimental group PREDINAM (TB patients) a) hospitalisation for severely ill TB patients, b) nutritional support for malnourished patients, c) Anti Retroviral Treatment (ART) for HIV-infected patients. 115
Experimental group PREDINAM (TB suspects) a) hospitalisation for severely ill patients suspected of TB, b) nutritional support for malnourished patients, c) Anti Retroviral Treatment (ART) for HIV-infected patients. 180
Control group Normal treatment (TB supects) Patients in this group will be treated according to the decision of the consulting doctor at the health center. 180

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
- adults (> 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. None 15 Years 100 Years 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 Den Centrale Videnskabsetiske Komité
Ethics Committee Address
Street address City Postal code Country
Slotsholmsgade 12 København K 1216 Denmark
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 2010/02/08 Camite Nacianal de Etjca na Saude
Ethics Committee Address
Street address City Postal code Country
Instituto Nacional de Saude Publica. Avenida Combatente da Liberdade de Pcitria, Hospital "3 de Agosto" ¿ Apartado: 861 Bissau Bissau Codex 1004 Guinea-Bisseu

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 12 month overall mortality in the high risk group with TBscore¿8 or suPAR¿4 - for every patient,12 month after inclusion
Secondary Outcome Weight gain, haemoglobin increase, TBscore/suPAR decrease - after finished treatment

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centro de Saude, Bandim Bandim Guinea-Bisseu
Centro de Saude, Belem Bissau Guinea-Bisseu
Centro de Saude, Cuntum Cuntum, Bissau Guinea-Bisseu
Hospital Raoul Follerau Follerau, Bissau Guinea-Bisseu

FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP 300 Laan van Nieuw Oost Indië The Hague 2509 AA Netherlands
Klinisk Forskningscenter Hvidovre København Denmark
Århus Universitets Forskningsfond Århus 8200 Denmark
A P Møller fonden (lægev. Fremme) Esplanaden 50 København K 1098 Denmark
Frimodt-Heineke Fonden Edelslundsvej 1A, 2.tv Klampenborg 2930 Denmark
Jacob og Olga Madsen Fond Nørre voldgade 88 København K 1359 Denmark
EDCTP 300 Laan van Nieuw Oost Indië The Hague 2509 AA Netherlands
Klinisk Forskningscenter Hvidovre København Denmark
Århus Universitets Forskningsfond Århus 8200 Denmark
A P Møller fonden (lægev. Fremme) Esplanaden 50 København K 1098 Denmark
Frimodt-Heineke Fonden Edelslundsvej 1A, 2.tv Klampenborg 2930 Denmark
Jacob og Olga Madsen Fond Nørre voldgade 88 København K 1359 Denmark

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Christian Wejse Department of Infectious Diseases, Aarhus University Hospital, Skejby. Brendstrupgaardsvej 100 Aarhus N 8200 Denmark Hospital
Primary Sponsor Christian Wejse Department of Infectious Diseases, Aarhus University Hospital, Skejby. Brendstrupgaardsvej 100 Aarhus N 8200 Denmark Hospital

COLLABORATORS
Name Street address City Postal code Country
Msc., PhD Jesper Eugen Olsen København Denmark
Prof., MD, Lars Jørgen Østergaard Århus Denmark
MD, PhD Christian Wejse Århus Denmark
Msc., PhD Jesper Eugen Olsen København Denmark
Prof., MD, Lars Jørgen Østergaard Århus Denmark
MD, PhD Christian Wejse Århus Denmark

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Ms Frauke Rudolf frauke.rudolf@ki.au.dk + 245 6895169 + 245 3 20 16 72
Street address City Postal code Country Position / Affiliation
apartado 861 Bissau Codex 1004 Guinea-Bisseu MD PhD student
Role Name Email Phone Fax
Scientific Enquiries Mr Christian Wejse wejse@dadlnet.dk Phone: +45-89498492
Street address City Postal code Country Position / Affiliation
Department of infectious diseases Skejby sygehus, Aarhus University Hospital Brendstrupgårdsvej Århus N 8200 Denmark PhD/Supervisor
Role Name Email Phone Fax
Principal Investigator Ms Frauke Rudolf frauke.rudolf@ki.au.dk + 245 6895169 + 245 3 20 16 72
Street address City Postal code Country Position / Affiliation
apartado 861 Bissau Codex Guinea-Bisseu MD PhD student