ToxoplasmosisEconToxoNCT05860998
Measuring the Prevalence of Toxoplasmosis and Its Socio-economic Consequences
An observational study of Toxoplasmosis and Rhd, run by University of Zurich.
Trial summary
The investigators propose a fast and inexpensive procedure to determine the prevalence of the Toxoplasmosis infection (Toxoplasma Gondii) in the general population, using response times in a cognitive task instead of costly medical tests. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Toxoplasmosis, Rhd
- What is being tested?
- Presence of Toxoplasma gondii IgG Antibodies
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2023to 30 Jul 2023
- Phase
- Observational
- 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 18 to 35 years
- All sexes
- Adult
Study population: Participants will be recruited among the student population of the University of Zürich according to the established procedures of the SNS Laboratory.
Who may be able to join
- Ability and willingness to participate in the study.
- Declaration of consent.
- Having RhD-Negative blood. This is because only RhD-negative blood type become slower when afflicted by Toxoplasmosis. Hence, the proposed analysis can only be performed on RhD-Negative people.
- Good English language skills (at least C1, to ensure understanding of all instructions and the declaration of consent).
Who cannot join
- Inability to give the declaration of consent.
- Any neurological disorders
- Reduced general health / chronic diseases (e.g. autoimmune disease, severe cardiovascular diseases, insulin-dependent diabetes, severe depression); chronic pain disorders
Trial locations and contacts
No sites are listed yet.
About this study
The investigators propose a fast and inexpensive procedure to determine the prevalence of the Toxoplasmosis infection (Toxoplasma Gondii) in the general population, using response times in a cognitive task instead of costly medical tests. Therefore, the investigators aim to measure the prevalence of Toxoplasmosis and its socio-economic consequences in the general population.
Read the detailed description
An estimated 2 billion humans worldwide are affected by the protozoan Toxoplasma gondii. The resulting Toxoplasmosis is considered one of the most important but most neglected parasitic infections. Toxoplasmosis has been linked to behavioral alterations in humans. While rarely resulting in an acute pathology, latent infections have been associated with non-clinical outcomes such as car accidents, impulsiveness, and suicides through the pathology's influence on personality and risk-taking behaviors.
Given the economic and social impact of these consequences, it is important to have reliable estimates of Toxoplasmosis prevalence. However, current methods involve costly, time-expensive medical tests, which are not always available, especially in developing countries. Therefore, simpler, inexpensive, and easily-scalable diagnostic methods would be highly valuable. For this reason, both the CDC and the WHO consider it a priority to improve diagnostic testing of Toxoplasmosis. This includes obtaining reliable and easily-implementable estimates at the population level, which is essential to gauge the magnitude of the problem and to inform and design health policy aimed at reducing the number of infections in the population.
Therefore, the investigators aim to determine the frequency of latent Toxoplasmosis infections in the general population in a simple, quick, and inexpensive way.
The key idea of simplifying the diagnosis of this infection is that Toxoplasmosis induces specific behavioral and physiological changes. It alters the levels of neurotransmitters such as dopamine and causes a delay in muscle response time. In particular, people with RhD-negative blood type become slower when afflicted by Toxoplasmosis, while the RhD-positive sub-population does not experience a change in response times. This relation is important because, while the distribution of blood types can be determined in an inexpensive way and is already commonly known at the aggregate level (RhD-negative are 15% in Caucasians, 8% in Africans, and 1% in Asians), the actual prevalence of the Toxoplasmosis infection is underinvestigated, and the respective tests are costly and not easily deployable in large numbers (especially in developing countries). The investigators aim to leverage on the differential effects of Toxoplasmosis on response times across blood types to estimate its latent diffusion.
Response times (RT) are known to be log-normally distributed [22]. This is crucial because mixtures of log-normally distributed variables are identifiable through standard statistical methods as e.g. finite mixture models [23]. The distribution of RTs in the population is a mixture of two different types, afflicted vs. non-afflicted, and the first group should show a systematic delay in RTs compared to the latter group. A finite mixture model can then be applied to a sample of RhD-negative individuals to estimate the characteristics of the two distributions and hence quantify both the magnitude of the delay in response times as well as the size of the afflicted group.
The investigators already obtained data showing that the proposed method is able to capture interesting and economically-relevant individual characteristics between those who are imputed to be afflicted by this parasite compared to those who do not. This first investigation also passed some preliminary validation. For example, those estimated to be afflicted by Toxoplasmosis are also those who are more likely to have a cat, which is the main vector of contagion for this parasite.
In this study the investigators propose a systematic validation of the proposed method. In particular, the investigators aim to compare it agrees with a standard medical test for Toxoplasmosis infection, e.g., compare it to the presence of Toxoplasma gondii IgG Antibodies. The latter medical test requires a blood sample.
- Conditions
- Toxoplasmosis, Rhd
- Being tested
- Presence of Toxoplasma gondii IgG Antibodies
- Keywords
- Toxoplasmosis, Rhd, Development of diagnostic tests, Neglected parasitic infections, Economic impact parasitic infections
- Medical subject headings
- Toxoplasmosis, Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of Toxoplasma gondii IgG AntibodiesDiagnostic test
Testing for the presence of Toxoplasma gondii IgG Antibodies in participants blood.
| Study group | Role | What they receive |
|---|---|---|
| Toxoplasmosis positive | Healthy students with RhD-Negative blood with Toxoplasma gondii IgG Antibodies Receives: Diagnostic Test: Presence of Toxoplasma gondii IgG Antibodies | |
| Toxoplasmosis negative | Healthy students with RhD-Negative blood without Toxoplasma gondii IgG Antibodies Receives: Diagnostic Test: Presence of Toxoplasma gondii IgG Antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Toxoplasma gondii IgG Antibodies
Presence of Toxoplasma gondii IgG Antibodies
Measured: 6 months
Classified as afflicted by Toxoplasma gondii using response times
Classification based on a reaction-time task of whether the participant is considered as afflicted by Toxoplasma gondii.
Measured: 6 months
Secondary outcomes (11)
Big 5 personality trait
Score in the Big 5 personality trait scale from Gosling et al. (2013). It is a 10-items scale subdivided in 5 traits (2 items for each trait): Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to Experiences. Each item is evaluated using a 7-points Likert scale with the following labels "Disagree Moderately", "Disagree a little", "Neither agree not disagree", "Agree a little", "Agree moderately", "Agree strongly". For each trait one of the two items is reversely scored. For each of the 5 traits the score of the two items is added, hence it can go from 2 to 14. Higher scores on each of the scales correspond higher closeness to that personality trait, e.g., more agreeable.
Measured: 6 months
Sensation Seeking scale
Score in the Sensation Seeking scale (Cook et al., 2015). This scale consists of 10 binary choices where participants are asked to choose which option best describes their likes or the way they feel. One of the two options is associated with a higher Sensation Seeking score. Items 2, 3, 5, 6, and 8 are reversely scored. The answers from the single items are added to obtain the total score, which can go from 0 to 10. Higher scores indicate more sensation seeking.
Measured: 6 months
Cognitive Reflection Test
Score in the Cognitive Reflection Test from Toplak, West, and Stanovich (2014). In this 7-item scale each item asks for the answer to a mathematical or logical problem in an open-entry format or as multiple-choice question. The score for this scale is the sum of the correct answer to the 7 items, hence it goes from 0 to 7. Higher scores indicate higher cognitive reflections.
Measured: 6 months
Risk aversion
Measure of risk aversion (number from 1 to 10, Falk et al., 2018). A single question asking the participants' attitude toward risk. 1 means "not willing to take risks" and 10 means "very willing to take risks". Higher values mean more risk tolerance.
Measured: 6 months
Time preference
Measure of time preference (number from 1 to 10, Falk et al., 2018). A single question asking the participants' patience. 1 means "not willing to give up something today" and 10 means "very willing to give up something today". Higher values mean more patience.
Measured: 6 months
Self-control
Score in the self-control scale from Tangney, Boone, and Baumeister (2018). It is a 13-item scale evaluated using a 5-point Likert scale with two labels at the extreme of the scale 1="Not at all" and 5="Very much". Items 2/5, 7, 9/11 are reversely scored. The score is obtained by adding the score of the single items. Higher values indicate more self control.
Measured: 6 months
Field of study
Which major the participant studied.
Measured: 6 months
Accidents
Number of accidents (work related or traffic accidents) the participant experienced.
Measured: 6 months
Owning Pets
Which pets the participant owns or owned.
Measured: 6 months
Income
The yearly income (in Swiss Francs).
Measured: 6 months
Alcohol consumption
Average units of alcohol consumed in a week.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start26 Jun 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxoplasmosisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Alós-Ferrer, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860998
- Sponsor's protocol ID
- 2023-00366
- Other IDs
- 2023
- Acronym
- EconToxo
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Prevalence of Toxoplasmosis and Its Socio-economic Consequences
- ClinicalTrials.gov ID
- NCT05860998
- Acronym / sponsor ID
- EconToxo / 2023-00366
- Conditions
- Toxoplasmosis, Rhd
- Keywords
- Toxoplasmosis, Rhd, Development of diagnostic tests, Neglected parasitic infections, Economic impact parasitic infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 26 Jun 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 16 May 2023 (actual)
- 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.
The investigators propose a fast and inexpensive procedure to determine the prevalence of the Toxoplasmosis infection (Toxoplasma Gondii) in the general population, using response times in a cognitive task instead of costly medical tests. Therefore, the investigators aim to measure the prevalence of Toxoplasmosis and its socio-economic consequences in the general population.
Detailed description
An estimated 2 billion humans worldwide are affected by the protozoan Toxoplasma gondii. The resulting Toxoplasmosis is considered one of the most important but most neglected parasitic infections. Toxoplasmosis has been linked to behavioral alterations in humans. While rarely resulting in an acute pathology, latent infections have been associated with non-clinical outcomes such as car accidents, impulsiveness, and suicides through the pathology's influence on personality and risk-taking behaviors.
Given the economic and social impact of these consequences, it is important to have reliable estimates of Toxoplasmosis prevalence. However, current methods involve costly, time-expensive medical tests, which are not always available, especially in developing countries. Therefore, simpler, inexpensive, and easily-scalable diagnostic methods would be highly valuable. For this reason, both the CDC and the WHO consider it a priority to improve diagnostic testing of Toxoplasmosis. This includes obtaining reliable and easily-implementable estimates at the population level, which is essential to gauge the magnitude of the problem and to inform and design health policy aimed at reducing the number of infections in the population.
Therefore, the investigators aim to determine the frequency of latent Toxoplasmosis infections in the general population in a simple, quick, and inexpensive way.
The key idea of simplifying the diagnosis of this infection is that Toxoplasmosis induces specific behavioral and physiological changes. It alters the levels of neurotransmitters such as dopamine and causes a delay in muscle response time. In particular, people with RhD-negative blood type become slower when afflicted by Toxoplasmosis, while the RhD-positive sub-population does not experience a change in response times. This relation is important because, while the distribution of blood types can be determined in an inexpensive way and is already commonly known at the aggregate level (RhD-negative are 15% in Caucasians, 8% in Africans, and 1% in Asians), the actual prevalence of the Toxoplasmosis infection is underinvestigated, and the respective tests are costly and not easily deployable in large numbers (especially in developing countries). The investigators aim to leverage on the differential effects of Toxoplasmosis on response times across blood types to estimate its latent diffusion.
Response times (RT) are known to be log-normally distributed [22]. This is crucial because mixtures of log-normally distributed variables are identifiable through standard statistical methods as e.g. finite mixture models [23]. The distribution of RTs in the population is a mixture of two different types, afflicted vs. non-afflicted, and the first group should show a systematic delay in RTs compared to the latter group. A finite mixture model can then be applied to a sample of RhD-negative individuals to estimate the characteristics of the two distributions and hence quantify both the magnitude of the delay in response times as well as the size of the afflicted group.
The investigators already obtained data showing that the proposed method is able to capture interesting and economically-relevant individual characteristics between those who are imputed to be afflicted by this parasite compared to those who do not. This first investigation also passed some preliminary validation. For example, those estimated to be afflicted by Toxoplasmosis are also those who are more likely to have a cat, which is the main vector of contagion for this parasite.
In this study the investigators propose a systematic validation of the proposed method. In particular, the investigators aim to compare it agrees with a standard medical test for Toxoplasmosis infection, e.g., compare it to the presence of Toxoplasma gondii IgG Antibodies. The latter medical test requires a blood sample.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toxoplasmosis positive | – | Diagnostic Test: Presence of Toxoplasma gondii IgG AntibodiesHealthy students with RhD-Negative blood with Toxoplasma gondii IgG Antibodies |
| Toxoplasmosis negative | – | Diagnostic Test: Presence of Toxoplasma gondii IgG AntibodiesHealthy students with RhD-Negative blood without Toxoplasma gondii IgG Antibodies |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- Participants will be recruited among the student population of the University of Zürich according to the established procedures of the SNS Laboratory.
Key inclusion criteria (4 listed)
- Ability and willingness to participate in the study.
- Declaration of consent.
- Having RhD-Negative blood. This is because only RhD-negative blood type become slower when afflicted by Toxoplasmosis. Hence, the proposed analysis can only be performed on RhD-Negative people.
- Good English language skills (at least C1, to ensure understanding of all instructions and the declaration of consent).
Key exclusion criteria (3 listed)
- Inability to give the declaration of consent.
- Any neurological disorders
- Reduced general health / chronic diseases (e.g. autoimmune disease, severe cardiovascular diseases, insulin-dependent diabetes, severe depression); chronic pain disorders
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 |
|---|---|---|
| Presence of Toxoplasma gondii IgG AntibodiesTesting for the presence of Toxoplasma gondii IgG Antibodies in participants blood. | Diagnostic test | Toxoplasmosis negative, Toxoplasmosis positive |
Primary outcome
Presence of Toxoplasma gondii IgG Antibodies
Time frame: 6 months
Presence of Toxoplasma gondii IgG Antibodies
Classified as afflicted by Toxoplasma gondii using response times
Time frame: 6 months
Classification based on a reaction-time task of whether the participant is considered as afflicted by Toxoplasma gondii.
11 secondary outcomes
Big 5 personality trait
Time frame: 6 months
Sensation Seeking scale
Time frame: 6 months
Cognitive Reflection Test
Time frame: 6 months
Risk aversion
Time frame: 6 months
Time preference
Time frame: 6 months
Self-control
Time frame: 6 months
Field of study
Time frame: 6 months
Accidents
Time frame: 6 months
Owning Pets
Time frame: 6 months
Income
Time frame: 6 months
Alcohol consumption
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxoplasmosis and Rhd, run by University of Zurich.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Alós-Ferrer, PhD (798667160 ext. +41, carlos.alos-ferrer@econ.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Toxoplasma gondii IgG Antibodies (time frame: 6 months). The study lists 2 primary outcomes in all. 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 18 May 2023.