Taenia Solium InfectionCYSTISTOPNCT02612896
Taenia Solium Elimination Versus Control: What is the Best Way Forward for Sub-Saharan Africa?
A study testing Mass drug administration, praziquantel 10mg/kg and Health education in people with Taenia Solium Infection, run by Institute of Tropical Medicine, Belgium at 1 site in Zambia.
Trial summary
Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with significant economic and public health impacts, occurring primarily in developing countries. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Taenia Solium Infection
- What is being tested?
- Mass drug administration, praziquantel 10mg/kg and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,900 participants
- Where
- 1 siteZambia
- Study dates
- Mar 2016to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets (the latter specific for the elimination arm)
- Willing and able to provide informed consent (signature or thumb print with impartial witness; assent for minors with parental consent).
- Living in, attending school in, or regularly visiting the bore holes present in, the study communities
- Aged five years of age or older
- People without epilepsy
Who cannot join
- 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 group discussions, or taking oral anthelmintic tablets (the latter specific for the elimination arm)
- Unwilling or unable to provide written (signature or thumb print with impartial witness) informed consent (or assent for minors)
- Living outside of, and not regularly visiting, or attending school in, the study communities
- Children aged four years or younger
- People with epilepsy (identified cases by the Rural Health Centre, questions included in the registration procedure)
- Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses)
Trial locations and contacts
1 site in 1 country.
About this study
Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with significant economic and public health impacts, occurring primarily in developing countries. Humans are the carriers of the tapeworm (taeniosis); the normal intermediate pig host develops the metacestode larval stage (porcine cysticercosis). However, people can also act as accidental intermediate hosts and develop human cysticercosis or neurocysticercosis (NCC) when the central nervous system is involved.
The scattered efforts of researchers into evaluation of control programmes in Sub-Saharan Africa (SSA) have focussed on single control options. It is becoming clear that these stand-alone options have the potential to reduce the occurrence of the parasite, however either long term or more integrated efforts seem to be required to reach an elimination status.
Read more
The objective of the current study is to evaluate the cost-effectiveness/acceptability of elimination (to be achieved on a short term via integrated measures), and control (single measures, with an elimination goal on a longer term) of T. solium in a highly endemic area in SSA.
This intervention study will entail an elimination study arm in which multiple control options are combined (integrated) aiming at the final human host (Mass drug administration (MDA) and health education) and pig intermediate hosts (pig treatment and vaccination). In a second study arm a single control option will be carried out (pig treatment). In both study arms (health) education will be implemented. At baseline and in the final sampling year, prevalence of human taeniosis/cysticercosis and porcine cysticercosis will be determined in all study villages. Active ongoing surveillance and 6 monthly (biannual) human and pig sampling will be conducted in the elimination study arm, as well as two-yearly (biennial) sampling of the pig intermediate host in the control study arm. Additionally, (open ended) questionnaires and focus group discussions will be administered/held to obtain data on the cost of pig keeping, T. solium, the interventions and the perception/acceptability of the proposed control measures to the local communities.
Read the detailed description
As T. solium is a zoonosis, it's control will be evaluated in a One Health perspective, tackling both the human and pig host. The study will be carried out in the Katete district, in the Eastern Province of Zambia, an area reported to be endemic for T. solium in both pigs and humans. The pig interventions will not be described here, as requested by ClinicalTrials.gov Suitability of communities in the Katete district was assessed during a pilot survey conducted by the proposers (April 2015).
Two communities were selected that fulfilled all of the eligibility criteria. The Nyembe neighbourhood community (1,210 people, 5 villages, 520 pigs), within the Nyembe Rural Health Centre (RHC) catchment was selected for the elimination study arm; and Chimvira neighbourhood community (1,470 people, 11 villages, 827 pigs), in the Mtandaza Rural Health Centre catchment, was selected for the control study arm.
The interventional study will entail a high-input elimination study arm (E), in which multiple control options targeting both the final (human, mass drug administration, health education) and intermediate (pig) hosts (treatment and vaccination), are combined; and a lower-input control study arm (CI), which will use a single control option targeting only the porcine host (treatment).
Teams of suitably qualified and trained human and veterinary medical staff will go from door-to-door to each household in the study communities.
Procedures will include collection of both qualitative and quantitative data from human participants and pigs; subject-related interventions in both human participants and pigs; and laboratory analysis of collected samples.
For the baseline surveys, one randomly-selected consenting adult member and one randomly-selected assenting (and parental consent) child member (above 5 years) from each household will be sampled (serum: diagnosis of human cysticercosis; and stool: diagnosis of taeniasis), whereas for all subsequent surveys in the elimination arm (see protocol for specific time points), all eligible consenting members of the elimination communities will be invited to participate (stool samples: diagnosis of taeniasis). All eligible consenting members from the control arm will be included at the final study sampling (stool: diagnosis of taeniasis and serum: diagnosis of cysticercosis). It is expected that all age, sex and socioeconomic groups will be equally represented.
For the socio-economic questionnaires, 50% of the households will be randomly selected and the head of the household addressed.
The school based questionnaire will be administered to grade 5-6 children attending school in each of the study communities.
For the perception questionnaires: here also 50% of the households will be targeted (random selection), until data saturation has been reached.
For the focus group discussions (FGD): 6 FGD (3 with each time 10 men, 3 with each time 10 women) will be conducted in the elimination study arm, 12 in the control study arm (6 iterations involving 10 men and 6 iterations involving 10 women), at defined time points (table 1), until data saturation has been reached.
- Conditions
- Taenia Solium Infection
- Being tested
- Mass drug administration, praziquantel 10mg/kg, Health education
- Keywords
- Taenia solium, control, elimination, One Health
- Medical subject headings
- Taeniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mass drug administration, praziquantel 10mg/kgDrug
Also called praziquantel
see previous, in elimination study arm only
Health educationBehavioural
Also called education
in all study arms, using village meetings, posters, pamphlets.
| Study group | Role | What they receive |
|---|---|---|
| Elimination arm | Experimental | Both human and porcine interventions at four-monthly intervals in the first two study years, for a total of six iterations (only human interventions will be detailed here):
Human: Mass drug administration, praziquantel 10mg/kg, according to the list of WHO recommended anthelmintic drugs for use in preventive chemotherapy for taeniasis. And Health Education Receives: Drug: Mass drug administration, praziquantel 10mg/kg; Behavioral: Health education |
| Control intervention arm | Experimental | Human: yearly health education, for a total of five iterations. The intervention on the pig host will not be detailed here) Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in porcine cysticercosis: in this One Health approach, the primary outcome is not a human measure
serological measurement of porcine cysticercosis (in pigs), antigen ELISA result: ratio
Measured: Elimination arm: day 0, Year 1, Year 2, Year 2.5, Year 3, Year 3.5, Year 4, Year 4.5, Year 5. Control intervention arm: day 0, Year 2, Year 4,Year 5
Secondary outcomes (3)
Change in human cysticercosis active infection (serum: )
human cysticercosis: serological diagnosis: B60/B158 Antigen-ELISA (ratio>1 is positive)
Measured: in both study arms: day 0, Year 5.
Change in human cysticercosis, exposure to infection (serum)
human cysticercosis: serological diagnosis: Enzyme-linked Electroimmunotransfer blot assay (EITB): number of bands: one band is positive
Measured: in both study arms: day 0, year 5
Change in human taeniasis (stool)
human taeniasis: coprological diagnosis: copro- antigen ELISA: Optical Density (OD) values (with all OD's higher then cutoff= positive) ; copro polymerase chain reaction (PCR) followed by restriction fragment length polymorphism (RFLP) if needed: band result leading to pos/neg. An individual is considered 'POSITIVE' if any of the test results is positive.
Measured: in both study arms: day 0, year 5; elimination study arm: Year 1, Year 2, year 2.5, year 3, year 3.5,year 4, year 4.5 and year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionOct 2021
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taenia Solium InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zambia, Ministry of Health, Zambia, Université Catholique de Louvain, University Ghent
- Responsible party
- Sponsor
- Investigators
- Pierre Dorny, PhD, Study chair, Institute of Tropical Medicine, BelgiumEmmanuel Bottieau, PhD, MD, Study chair, Institute of Tropical Medicine, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612896
- Sponsor's protocol ID
- CYSTISTOP_2.2_07012016
- Acronym
- CYSTISTOP
- Status last verified
- Feb 2023
- First submitted
- 17 Nov 2015
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taenia Solium Elimination Versus Control: What is the Best Way Forward for Sub-Saharan Africa?
- ClinicalTrials.gov ID
- NCT02612896
- Acronym / sponsor ID
- CYSTISTOP / CYSTISTOP_2.2_07012016
- Conditions
- Taenia Solium Infection
- Keywords
- Taenia solium, control, elimination, One Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,900 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University of Zambia, Ministry of Health, Zambia, Université Catholique de Louvain, University Ghent
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Taenia solium taeniosis/cysticercosis is a neglected zoonotic parasitic disease complex with significant economic and public health impacts, occurring primarily in developing countries. Humans are the carriers of the tapeworm (taeniosis); the normal intermediate pig host develops the metacestode larval stage (porcine cysticercosis). However, people can also act as accidental intermediate hosts and develop human cysticercosis or neurocysticercosis (NCC) when the central nervous system is involved.
The scattered efforts of researchers into evaluation of control programmes in Sub-Saharan Africa (SSA) have focussed on single control options. It is becoming clear that these stand-alone options have the potential to reduce the occurrence of the parasite, however either long term or more integrated efforts seem to be required to reach an elimination status.
The objective of the current study is to evaluate the cost-effectiveness/acceptability of elimination (to be achieved on a short term via integrated measures), and control (single measures, with an elimination goal on a longer term) of T. solium in a highly endemic area in SSA.
This intervention study will entail an elimination study arm in which multiple control options are combined (integrated) aiming at the final human host (Mass drug administration (MDA) and health education) and pig intermediate hosts (pig treatment and vaccination). In a second study arm a single control option will be carried out (pig treatment). In both study arms (health) education will be implemented. At baseline and in the final sampling year, prevalence of human taeniosis/cysticercosis and porcine cysticercosis will be determined in all study villages. Active ongoing surveillance and 6 monthly (biannual) human and pig sampling will be conducted in the elimination study arm, as well as two-yearly (biennial) sampling of the pig intermediate host in the control study arm. Additionally, (open ended) questionnaires and focus group discussions will be administered/held to obtain data on the cost of pig keeping, T. solium, the interventions and the perception/acceptability of the proposed control measures to the local communities.
Detailed description
As T. solium is a zoonosis, it's control will be evaluated in a One Health perspective, tackling both the human and pig host. The study will be carried out in the Katete district, in the Eastern Province of Zambia, an area reported to be endemic for T. solium in both pigs and humans. The pig interventions will not be described here, as requested by ClinicalTrials.gov Suitability of communities in the Katete district was assessed during a pilot survey conducted by the proposers (April 2015).
Two communities were selected that fulfilled all of the eligibility criteria. The Nyembe neighbourhood community (1,210 people, 5 villages, 520 pigs), within the Nyembe Rural Health Centre (RHC) catchment was selected for the elimination study arm; and Chimvira neighbourhood community (1,470 people, 11 villages, 827 pigs), in the Mtandaza Rural Health Centre catchment, was selected for the control study arm.
The interventional study will entail a high-input elimination study arm (E), in which multiple control options targeting both the final (human, mass drug administration, health education) and intermediate (pig) hosts (treatment and vaccination), are combined; and a lower-input control study arm (CI), which will use a single control option targeting only the porcine host (treatment).
Teams of suitably qualified and trained human and veterinary medical staff will go from door-to-door to each household in the study communities.
Procedures will include collection of both qualitative and quantitative data from human participants and pigs; subject-related interventions in both human participants and pigs; and laboratory analysis of collected samples.
For the baseline surveys, one randomly-selected consenting adult member and one randomly-selected assenting (and parental consent) child member (above 5 years) from each household will be sampled (serum: diagnosis of human cysticercosis; and stool: diagnosis of taeniasis), whereas for all subsequent surveys in the elimination arm (see protocol for specific time points), all eligible consenting members of the elimination communities will be invited to participate (stool samples: diagnosis of taeniasis). All eligible consenting members from the control arm will be included at the final study sampling (stool: diagnosis of taeniasis and serum: diagnosis of cysticercosis). It is expected that all age, sex and socioeconomic groups will be equally represented.
For the socio-economic questionnaires, 50% of the households will be randomly selected and the head of the household addressed.
The school based questionnaire will be administered to grade 5-6 children attending school in each of the study communities.
For the perception questionnaires: here also 50% of the households will be targeted (random selection), until data saturation has been reached.
For the focus group discussions (FGD): 6 FGD (3 with each time 10 men, 3 with each time 10 women) will be conducted in the elimination study arm, 12 in the control study arm (6 iterations involving 10 men and 6 iterations involving 10 women), at defined time points (table 1), until data saturation has been reached.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elimination arm | Experimental | Drug: Mass drug administration, praziquantel 10mg/kg, Behavioral: Health educationBoth human and porcine interventions at four-monthly intervals in the first two study years, for a total of six iterations (only human interventions will be detailed here): Human: Mass drug administration, praziquantel 10mg/kg, according to the list of WHO recommended anthelmintic drugs for use in preventive chemotherapy for taeniasis. And Health Education |
| Control intervention arm | Experimental | Behavioral: Health educationHuman: yearly health education, for a total of five iterations. The intervention on the pig host will not be detailed here) |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets (the latter specific for the elimination arm)
- Willing and able to provide informed consent (signature or thumb print with impartial witness; assent for minors with parental consent).
- Living in, attending school in, or regularly visiting the bore holes present in, the study communities
- Aged five years of age or older
- People without epilepsy
Key exclusion criteria (6 listed)
- 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 group discussions, or taking oral anthelmintic tablets (the latter specific for the elimination arm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mass drug administration, praziquantel 10mg/kgAlso: praziquantelsee previous, in elimination study arm only | Drug | Elimination arm |
| Health educationAlso: educationin all study arms, using village meetings, posters, pamphlets. | Behavioural | Control intervention arm, Elimination arm |
Primary outcome
Change in porcine cysticercosis: in this One Health approach, the primary outcome is not a human measure
Time frame: Elimination arm: day 0, Year 1, Year 2, Year 2.5, Year 3, Year 3.5, Year 4, Year 4.5, Year 5. Control intervention arm: day 0, Year 2, Year 4,Year 5
serological measurement of porcine cysticercosis (in pigs), antigen ELISA result: ratio
3 secondary outcomes
Change in human cysticercosis active infection (serum: )
Time frame: in both study arms: day 0, Year 5.
Change in human cysticercosis, exposure to infection (serum)
Time frame: in both study arms: day 0, year 5
Change in human taeniasis (stool)
Time frame: in both study arms: day 0, year 5; elimination study arm: Year 1, Year 2, year 2.5, year 3, year 3.5,year 4, year 4.5 and year 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
Related trials for Taenia Solium Infection
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Dorny, PhD study chair
Institute of Tropical Medicine, Belgium
Emmanuel Bottieau, PhD, MD study chair
Institute of Tropical Medicine, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mass drug administration, praziquantel 10mg/kg and Health education in people with Taenia Solium Infection, run by Institute of Tropical Medicine, Belgium at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in porcine cysticercosis: in this One Health approach, the primary outcome is not a human measure (time frame: Elimination arm: day 0, Year 1, Year 2, Year 2.5, Year 3, Year 3.5, Year 4, Year 4.5, Year 5. Control intervention arm: day 0, Year 2, Year 4,Year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.