Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Actual trial start date |
09/01/2018 |
Start recruitment Zambia site |
|
2017-12-04 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial type |
04/12/2017 |
Modified |
Others |
RCT |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Intervention assignment |
22/11/2017 |
Email registry admin: this is a Diagnostic study: eligible participants will be tested with the POC test (=index) test, and subsequently, depending on the result and following the different flow charts will be requested (or not) for additional testing (reference testing on serum/stool, clinical examinations, CT scanning). this does not really fit in any of the options presented here. "Parallel" fitted best. |
|
Parallel: different groups receive different interventions at same time during study |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial phase |
04/07/2018 |
Pactr update |
|
Not Applicable |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Sub disease(s) |
04/07/2018 |
pactr update |
|
Other |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Other Infections and Infestation disease |
04/07/2018 |
pactr update |
|
neurocysticercosis, taeniosis |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
04/07/2018 |
Pactr update |
|
Control Group, Diagnostic study Zambia, index test administered on all eligible participants, NA, First index testing, depending on the outcome and following flow charts, the study subject will be requested (or not) to give additional samples (serum/stool) for reference testing, and undergo (or not) additional clinical examinations and CT scanning. , 1200, Active-Treatment of Control Group |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
18/10/2018 |
Ethics letter received |
TRUE, University of Zambia Biomedical Research Ethics Committee, University of Zambia, Ridgeway Campus, POBox 50110 Lusaka, Zambia, Lusaka, Pobox 50110, Zambia, , 13 Sep 2017, +260 256067, , |
TRUE, University of Zambia Biomedical Research Ethics Committee, University of Zambia, Ridgeway Campus, POBox 50110 Lusaka, Zambia, Lusaka, 50100, Zambia, , 13 Sep 2017, +260012560670, unzarec@unza.zm, 2788_2223_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
18/10/2018 |
Ethics letter received |
TRUE, Universiteit Antwerpen Ethisch Comite, UZA, Wilrijkstraat 10, Edegem, 2650 , Belgium, , 18 Sep 2017, +3238213000, , |
TRUE, Universiteit Antwerpen Ethisch Comite, UZA, Wilrijkstraat 10, Edegem, 20000, Belgium, , 18 Sep 2017, +323813000, etisch.comite@uza.be, 2788_2224_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
18/10/2018 |
ethics letters received |
TRUE, National Health Research Ethics CommitteeNational Institute for Medical Research, 3 Barack Obama Drive, Dar es Salaam, 11101, Tanzania, , 10 Oct 2017, , , |
TRUE, National Health Research Ethics CommitteeNational Institute for Medical Research, 3 Barack Obama Drive, Dar es Salaam, 10000, Tanzania, , 10 Oct 2017, +255222121400, ethics@nimr.or.tz, 2788_2228_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
18/10/2018 |
recruitment has started |
Not yet recruiting |
Recruiting |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
05/11/2020 |
recruitment completed |
Recruiting |
Closed to recruitment,follow-up continuing |