|
Main
|
|
Note: This record shows only 22 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 May 2023 |
|
Main ID: |
PACTR201611001838365 |
|
Date of registration:
|
29/10/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
ClinPOC TB
|
|
Scientific title:
|
Clinical scoring tool for point-of-care diagnosis of tuberculosis |
|
Date of first enrolment:
|
01/09/2016 |
|
Target sample size:
|
3600 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1838 |
|
Study type:
|
Interventional |
|
Study design:
|
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
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Ethiopia
|
Guinea-Bisseu
| | | | | | |
|
Contacts
|
|
Name:
|
Frauke
Rudolf |
|
Address:
|
Dep of Infectious medicine, Palle Juul-Jensens Boulevard 99
8200
Århus
Denmark |
|
Telephone:
|
+4551372359 |
|
Email:
|
frauke.rudolf@clin.au.dk |
|
Affiliation:
|
|
|
|
Name:
|
Frauke
Rudolf |
|
Address:
|
Dep of Infectious medicine, Palle Juul-Jensens Boulevard 99
8200
Århus
Denmark |
|
Telephone:
|
+4551372359 |
|
Email:
|
frauke.rudolf@clin.au.dk |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: All adult patients aged >15 years
Cough (regardless of duration) and/or weight loss and/or expectoration.
Exclusion criteria: TB treatment within the past year.
Patients with cerebral disturbances that complicates the ability to give informed consent or follow the treatment regime.
Age minimum:
15 Year(s)
Age maximum:
130 Year(s)
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Tuberculosis
|
|
Tuberculosis
|
|
Intervention(s)
|
|
|
|
Enhanced usual care
|
|
TBscore
|
|
Primary Outcome(s)
|
|
) Increase in diagnostic yield of active TB compared to baseline and control EUC clinics and time to diagnosis compared to standard care.
|
|
Secondary Outcome(s)
|
|
To further strengthen the trial capacity built under EDCTP1 at sites in Guinea Bissau and Ethiopia.
|
|
Usability of the Bandim TBscore at points of healthcare.
|
|
) Effect on treatment outcomes (for TB diagnosed patients) and all cause mortality 12 month after first encounter (for all included).
|
|
Diagnostic yield as of sputum smear microscopy (smear positive cases) and as of chest x-ray and antibiotic treatment/ GenXpert (smear negative cases).
|
|
Source(s) of Monetary Support
|
|
University of Gondar
|
|
Novo Nordisk Foundation
|
|
Ethics review
|
Status: Approved
Approval date: 06/06/2016
Contact:
Comite Nacional de Etica na Saude
|
Status: Approved
Approval date: 13/10/2016
Contact:
Danish National Comittee on Health Research Ethics
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|