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.: PACTR201611001838365 Date of Approval: 29/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ClinPOC TB
Official scientific title Clinical scoring tool for point-of-care diagnosis of tuberculosis
Brief summary describing the background and objectives of the trial We have developed and validated a clinical scoring tool (the Bandim TBscore). The tool may increase the diagnostic yield of tuberculosis (TB) and describes the risk of active TB disease and mortality prognosis accurately, requiring only limited training and no expensive reagents or devices. In 2014 more than three million people with TB remained undiagnosed resulting in stable sources of infection. The Bandim TBscore might give us the possibility to improve case-finding instantly. It is cost-effective, scalable and field-friendly and we have previously shown that it can be used in case-finding in low resource-settings and help identify TB patients in clinics treating patients infected with human immunodeficiency virus (HIV). We will conduct a cluster-randomized trial to evaluate the use and implementation of the TBscore to improve management of TB in real-life settings. The primary aims are to show that use of the TBscore may: 1. Increase the early detection of TB. 2. Decrease mortality among presumed TB (preTB) patients using the TBscore as triage for intensified follow-up. We will randomize clinics to implementation of the TBscore in screening preTB patients compared with standard care in the other clinics. Adult consultations in Guinea Bissau and Ethiopia will be randomized and all patients with a TBscore ¿ 3 at intervention clinics will be referred for sputum examination, and all with a TBscore ¿ 6 will enter an intensified follow-up with close monitoring of status and possible hospitalization. Our study takes forward existing collaborations between Denmark- Guinea Bissau and Sweden-Ethiopia enhancing networks across Africa, uniting research in high prevalence areas to combat TB.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ClinPOC TB
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/09/2016
Actual trial start date 01/10/2016
Anticipated date of last follow up 18/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 3600
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Crossover: all participants receive all interventions in different sequence during study Randomised Stepped wedge = all centers (clusters) get the intervention at a given (randomized timepoint). seequence is generated by computer program If switching to intervention, alla patients are given the intervention, so no concealing was necessary Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TBscore Using the TBscore to determine whom to refer to diagnostic tests. 1800
Control Group Enhanced usual care Control Health Centers will use usual algorithm to determine whom to refer to further diagnostic testing. 1800 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients aged >15 years Cough (regardless of duration) and/or weight loss and/or expectoration. TB treatment within the past year. Patients with cerebral disturbances that complicates the ability to give informed consent or follow the treatment regime. 15 Year(s) 130 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 13/10/2016 Danish National Comittee on Health Research Ethics
Ethics Committee Address
Street address City Postal code Country
Holbergsgade 6 Copenhagen 1057 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 06/06/2016 Comite Nacional de Etica na Saude
Ethics Committee Address
Street address City Postal code Country
Bissau Guinea-Bisseu
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ) Increase in diagnostic yield of active TB compared to baseline and control EUC clinics and time to diagnosis compared to standard care. end of trial
Secondary Outcome ) Effect on treatment outcomes (for TB diagnosed patients) and all cause mortality 12 month after first encounter (for all included). end of trial
Secondary Outcome Usability of the Bandim TBscore at points of healthcare. end of trial
Secondary Outcome Diagnostic yield as of sputum smear microscopy (smear positive cases) and as of chest x-ray and antibiotic treatment/ GenXpert (smear negative cases). end of trial
Secondary Outcome To further strengthen the trial capacity built under EDCTP1 at sites in Guinea Bissau and Ethiopia. during trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centro de Saude Belem Bissau Guinea-Bisseu
Centro de Saude Bairro Ajuda Bissau Guinea-Bisseu
Maraki Health Center P.O Box 196 Gondar Ethiopia
Gondar Health Center P.O Box 196 Gondar Ethiopia
Azezo Health Center P.O Box 196 Gondar Ethiopia
Centro de Saude Bandim Bissau Guinea-Bisseu
FUNDING SOURCES
Name of source Street address City Postal code Country
Novo Nordisk Foundation Tuborg Havnevej 19 Copenhagen 2900 Denmark
University of Gondar P.O Box 196 Gondar Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Novo Nordisk Foundation Turborg Havnevej 19 Hellerup 2900 Denmark Charities/Societies/Foundation
Primary Sponsor Gondar University P.O Box 196 Gondar Ethiopia Funding Agency
Primary Sponsor Århus University, Global Health Bartholins Alle 2 Arhus 8000 Denmark University
COLLABORATORS
Name Street address City Postal code Country
Ebba Abate P.O Box 196 Gondar Ethiopia
Frauke Rudolf Palle juul-jenses Boulevard Århus Denmark
Christian Wejse Bartholins Alle 2 Århus Denmark
Thomas Schön Linköping Sweden
Victor Gomes Bissau Guinea-Bisseu
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frauke Rudolf frauke.rudolf@clin.au.dk +4551372359 Dep of Infectious medicine, Palle Juul-Jensens Boulevard 99
City Postal code Country Position/Affiliation
Århus 8200 Denmark Fellow
Role Name Email Phone Street address
Public Enquiries Frauke Rudolf frauke.rudolf@clin.au.dk +4551372359 Dep of Infectious medicine, Palle Juul-Jensens Boulevard 99
City Postal code Country Position/Affiliation
Århus 8200 Denmark
Role Name Email Phone Street address
Scientific Enquiries Frauke Rudolf frauke.rudolf@clin.au.dk +4551372359 Dep of Infectious medicine, Palle Juul-Jensens Boulevard 99
City Postal code Country Position/Affiliation
Århus 8200 Denmark
REPORTING
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