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.: PACTR201712002788898 Date of Approval: 21/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of an antibody detecting point-of-care test for the diagnosis of Taenia solium taeniosis and (euro)cysticercosis in Tanzania and Zambia
Official scientific title Evaluation of an antibody detecting point-of-care test for the diagnosis of Taenia solium taeniasis and (neuro)cysticercosis in communities and district hospitals of highly endemic, resource-poor areas in sub Saharan Africa, including capacity building
Brief summary describing the background and objectives of the trial Taenia solium taeniasis/cysticercosis (T/CC) is a neglected zoonotic parasitic disease complex with significant economic and public health impacts. It has been ranked first on the global scale of foodborne parasitoses by FAO/WHO (2014). Neurocysticercosis (NCC) is estimated to be responsible for 30% of cases of acquired epilepsy in endemic areas. Currently, there are no cheap, easy to apply, sensitive and specific diagnostic tools available for the detection of this parasite. The lateral flow test from CDC Atlanta that combines the diagnosis of (neuro) cysticercosis with the diagnosis of taeniasis, is a very promising candidate. This point-of-care (POC) test would be a major breakthrough, an enormous added value in early neurocysticercosis case- and tapeworm carrier detection and management, contributing not only significantly to improved health outcomes but also to reducing the risk of transmission. It will furthermore contribute to obtaining more epidemiological information on infection occurrence and transmission dynamics, facilitating burden of disease calculations and subsequent advocacy. The main objective of this study is to contribute to the implementation of a rapid, cheap and simple POC test for the detection of T. solium taeniasis and (neuro)cysticercosis in two resource-poor, highly endemic areas in sub-Saharan Africa. The proposed project will therefore field validate the POC test, which simultaneously detects T. solium taeniasis and (neuro)cysticercosis, in Tanzania and Zambia, at the community and district health facility levels. The project also aims to improve the T. solium disease recognition, diagnostic and clinical case management capacities of these countries as well as their capacity to conduct diagnostic and clinical studies.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SOLID
Disease(s) or condition(s) being studied Infections and Infestations,neurocysticercosis, taeniosis
Sub-Disease(s) or condition(s) being studied neurocysticercosis, taeniosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 02/12/2017
Actual trial start date 04/12/2017
Anticipated date of last follow up 15/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 3800
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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
Parallel: different groups receive different interventions at same time during study Randomised Diagnostic study with randomised and non-randomised part, randomisation based on household codes, tallying and coin-tossing NA, diagnostic study Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Diagnostic study Tanzania 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. 2600
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
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Tanzania NCC: Patients 10 years of age and above with on-going symptoms of severe progressive headache impeding the daily activities without fever and without signs of cerebral infection or other obvious causes OR patients 10 years of age and above with a history of one or more epileptic seizures without obvious causes ¿ Patients willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey, and undergoing brain CT Scan if indicated ¿ Patients willing and able to provide written informed consent ¿ Patients living in the study area for the past three months and planning to stay in the same area throughout the study period Tanzania T: Patient must be 10 years and above and present at the out-patient clinic with (1) intestinal complaints compatible with intestinal worm infection (diarrhoea > 2 weeks and/or abdominal pain/discomfort > 2 weeks and/or recent history of worm expulsion): SELECTIVE GROUP (2) any other symptom not immediately linked with intestinal worm infection: RANDOM GROUP ¿ Patients willing and able to provide written informed consent ¿ Patients living in the study area for the past three months and planning to stay in the same area throughout the study period Zambia (N)CC and T: Patients willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey, and undergoing brain CT scan if indicated ¿ Willing and able to provide written informed consent Living, attending school, or regularly visiting the bore holes present in the study communities ¿ Aged 10 years of age or older PhD study: Individuals involved in the preparation of pork and that usually also eat pork ¿ Individuals older than 18 years of age ¿ Individuals willing and able to provide written informed consent Tanzania NCC: ¿ Patients less than 10 years of age ¿ Patients with any acute febrile illness ¿ Patients with fever and signs and symptoms for middle ear infection ¿ Patients with signs and symptoms of meningitis ¿ Patients with neck muscle pain and stiffness ¿ Patients with a history of stroke with neurological focal deficit ¿ Patients not willing or able to provide written informed consent (assent for minors) ¿ Patients not resident in the study area ¿ Patients reported pregnant Tanzania T: Patients below the age of 10 years ¿ Patients with acute severe illness that need in-patient care ¿ Patients not willing or able to provide written informed consent (assent for minors) ¿ Patient not resident in the study area Zambia: Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey, and undergoing brain CT scan if indicated (clinically or per protocol) ¿ Unwilling or unable to provide written informed consent (assent for minors with consent from a parent or a legally authorised representative) ¿ Living outside of, and not regularly visiting, or attending school in, the study communities ¿ Children below the age of 10 years ¿ Children below the age of 10 years with severe malnutrition ¿ Reported pregnant Seriously ill (unable to engage in the normal activities of daily living without assistance because of the illnesses) PhD: Individuals below the age of 18 years ¿ Individuals not willing or able to provide written informed consent ¿ Individuals that previously participated in T. solium research projects 10 Year(s) 140 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 13/09/2017 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Zambia, Ridgeway Campus, POBox 50110 Lusaka, Zambia Lusaka 50100 Zambia
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 18/09/2017 Universiteit Antwerpen Ethisch Comite
Ethics Committee Address
Street address City Postal code Country
UZA, Wilrijkstraat 10 Edegem 20000 Belgium
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 10/10/2017 National Health Research Ethics CommitteeNational Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 10000 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome POC test sensitivity and specificity for the detection of taeniosis and (neuro) csyticercosis at community level (Zambia) and at district hospital level (Tanzania) end of study
Secondary Outcome Tanzania: Behavioural change following health education end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mtandaza Rural Health Centre Sinda P.O BOX 580093 Zambia
Tukuyu Government Hospital Makandana area Tukuyu P.O. Box 148 Tanzania
Mbalizi Council Designated Hospital (Ifisi Hospitali Teule) Mbeya P.O. Box 6117 Tanzania
Vwawa Hospital Vwawa mjini Mbozi P.O. Box 70 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Netherlands
Bundesministerium fur Bildung und Forschung BMBF Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institute of Tropical Medicine Nationalestraat 155 Antwerp 2000 Belgium Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Chiara Trevisan ITM Belgium
Pierre Dorny ITM Belgium
Emmanuel Bottieau ITM Belgium
Sarah Gabriël UGhent Belgium
Inge Van Damme UGhent Belgium
Emmanuel Abatih UGhent Belgium
Veronika Schmidt TUM Germany
Andrea Winkler TUM Germany
Maria Vang Johansen UCopenhagen Denmark
Pascal Magnussen UCopenhagen Denmark
Rune Stensvold SSI Denmark
Bernard Ngowi NIMRI Tanzania
Benedict Ndawi MoH Tanzania
Helena Ngowi SUA Tanzania
Kabemba Evans Mwape UNZA Zambia
Gideon Zulu MoH Zambia
Isaac Phiri UNZA Zambia
Chisala Chabala UTH, UNZA Zambia
Chisala Chabala UTH, UNZA Zambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bernard Ngowi b_ngowi@yahoo.co.uk +255763918181 NIMR Muhimbili
City Postal code Country Position/Affiliation
Dar es salaam POBox 3436 Tanzania National Institute for Medical Research
Role Name Email Phone Street address
Principal Investigator Kabemba Evans Mwape kemwape@yahoo.com +260977819236 University of Zambia, Great East Rd
City Postal code Country Position/Affiliation
Lusaka Box 32379 Zambia University of Zambia
Role Name Email Phone Street address
Public Enquiries Sarah GABRIEL sarah.gabriel@ugent.be +3292647737 Salisburylaan 133
City Postal code Country Position/Affiliation
Merelbeke 9820 Belgium Ghent University
Role Name Email Phone Street address
Scientific Enquiries Sarah GABRIEL sarah.gabriel@ugent.be +3292647737 Salisburylaan 133
City Postal code Country Position/Affiliation
Merelbeke 9820 Belgium Ghent University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
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
Trial Information Trial phase 04/07/2018 Pactr update Not Applicable
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 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
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 Sub disease(s) 04/07/2018 pactr update Other
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 Other Infections and Infestation disease 04/07/2018 pactr update neurocysticercosis, taeniosis