Taenia Solium TaeniasisNCT01296958
Targeted Screening for Taenia Solium Tapeworms
A study testing Niclosamide and Community education campaign in people with Taenia Solium Taeniasis, run by Oregon Health and Science University at 1 site in Peru.
Trial summary
The purpose of this study is to determine whether screening and treatment of tapeworm carriers can decrease community transmission of Taenia solium parasitic infection. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Taenia Solium Taeniasis
- What is being tested?
- Niclosamide and Community education campaign
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,811 participants
- Where
- 1 sitePeru
- Study dates
- May 2011to Jan 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All community members are eligible
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether screening and treatment of tapeworm carriers can decrease community transmission of Taenia solium parasitic infection.
- Conditions
- Taenia Solium Taeniasis
- Being tested
- Niclosamide, Community education campaign
- Keywords
- Taenia solium, cysticercosis, neurocysticercosis
- Medical subject headings
- Taeniasis, Cysticercosis, Neurocysticercosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiclosamideDrug
Single oral dose of niclosamide determined by weight (dose: 11 to 34kg receive 1 gram, 35 to 50kg receive 1.5 grams, over 50kg receive 2 grams)
Community education campaignBehavioural
Education about prevention of Taenia solium infection provided in a single short (20 minute) interaction with the participant. Education was verbal with visual aids.
| Study group | Role | What they receive |
|---|---|---|
| Targeted screening | Experimental | Screening for intestinal tapeworm carrier followed by treatment with niclosamide as indicated. Receives: Drug: Niclosamide |
| Education | Active comparator | Community education about Taenia solium prevention. Receives: Behavioral: Community education campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Porcine seroprevalence
Measured: Every 4 months
Secondary outcomes (1)
Intestinal tapeworm prevalence
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taenia Solium TaeniasisStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National University of San Marcos, Peru, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Seth E O'Neal, MD MPH, Oregon Health and Science University
- Investigators
- Seth E ONeal, MD MPH, Principal investigator, Oregon Health and Science UniversityArmando Gonzalez, DVM PhD, Principal investigator, San Marcos University School of Veterinary Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296958
- Sponsor's protocol ID
- 1R21NS069275-01
- Other IDs
- 1R21NS069275-01
- Status last verified
- Oct 2014
- First submitted
- 15 Feb 2011
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Screening for Taenia Solium Tapeworms
- ClinicalTrials.gov ID
- NCT01296958
- Acronym / sponsor ID
- 1R21NS069275-01
- Conditions
- Taenia Solium Taeniasis
- Keywords
- Taenia solium, cysticercosis, neurocysticercosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,811 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National University of San Marcos, Peru, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Feb 2011 (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.
The purpose of this study is to determine whether screening and treatment of tapeworm carriers can decrease community transmission of Taenia solium parasitic infection.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted screening | Experimental | Drug: NiclosamideScreening for intestinal tapeworm carrier followed by treatment with niclosamide as indicated. |
| Education | Active comparator | Behavioral: Community education campaignCommunity education about Taenia solium prevention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All community members are eligible
Key exclusion criteria (1 listed)
- Inability to provide informed consent
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 |
|---|---|---|
| NiclosamideSingle oral dose of niclosamide determined by weight (dose: 11 to 34kg receive 1 gram, 35 to 50kg receive 1.5 grams, over 50kg receive 2 grams) | Drug | Targeted screening |
| Community education campaignEducation about prevention of Taenia solium infection provided in a single short (20 minute) interaction with the participant. Education was verbal with visual aids. | Behavioural | Education |
Primary outcome
Porcine seroprevalence
Time frame: Every 4 months
1 secondary outcome
Intestinal tapeworm prevalence
Time frame: 16 months
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 24 Oct 2014.
Related trials for Taenia Solium Taeniasis
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.
Seth E ONeal, MD MPH principal investigator
Oregon Health and Science University
Armando Gonzalez, DVM PhD principal investigator
San Marcos University School of Veterinary Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niclosamide and Community education campaign in people with Taenia Solium Taeniasis, run by Oregon Health and Science University at 1 site in Peru.
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 1 inclusion and 1 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 24 Oct 2014. 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 Peru. 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?
Porcine seroprevalence (time frame: Every 4 months). 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 24 Oct 2014.