Intestinal ParasitismNCT00138359
Mass Treatment T Solium Community Study
A study testing Niclosamide in people with Intestinal Parasitism, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Peru.
Trial summary
Investigators from Cayetano Heredia University and Johns Hopkins University are doing this study. They want to see how people and pigs get infected with a parasite, called cysticercus (known as "pig triquina"). Cysticercus attacks the meat of pigs and the brains of people. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Parasitism
- What is being tested?
- Niclosamide
- How many people
- 4,200 participants
- Where
- 1 sitePeru
- Study dates
- Dec 2004to Jan 2005
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All consenting individuals older than two years living in the study villages (6 endemic communities of the Northern coast of Peru)
Who cannot join
- Pregnancy (for antiparasitic treatment only).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Single Control Intervention in the T Solium Life Cycle
Investigators from Cayetano Heredia University and Johns Hopkins University are doing this study. They want to see how people and pigs get infected with a parasite, called cysticercus (known as "pig triquina"). Cysticercus attacks the meat of pigs and the brains of people. In the intestine, the parasite is known as "solitaria". This study is to see how treatment in both people and pigs works to control the disease.
Read the detailed description
This is a prospective intervention study to determine the efficacy and persistence of effect over time of a single, chemotherapy intervention in both the human and porcine population. Four villages will be selected to be treated against T solium adult (in humans) and larval forms (in pigs), and two villages will receive no intervention and will serve as control villages. Pigs in control villages will be followed during 3 months only, and then the human and porcine populations will receive the intervention treatment. The effect of this intervention will be measured by the prevalence of infection in pigs and parasitic burden of infected pigs at month 3, 6, 9, and 12.
- Conditions
- Intestinal Parasitism
- Being tested
- Niclosamide
- Keywords
- T solium, cysticercus, pig triquina, solitaria, intestinal parasites, Niclosamide, tapeworms, Taeniasis
- Medical subject headings
- Intestinal Diseases, Parasitic, Cestode Infections, Taeniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiclosamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startDec 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal ParasitismStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,200 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138359
- Sponsor's protocol ID
- 04-043
- Status last verified
- Dec 2006
- First submitted
- 26 Aug 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Control Intervention in the T Solium Life Cycle
- ClinicalTrials.gov ID
- NCT00138359
- Acronym / sponsor ID
- 04-043
- Conditions
- Intestinal Parasitism
- Keywords
- T solium, cysticercus, pig triquina, solitaria, intestinal parasites, Niclosamide, tapeworms, Taeniasis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4,200 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2004
- Study completion
- Jan 2005
- First posted
- 30 Aug 2005 (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.
Investigators from Cayetano Heredia University and Johns Hopkins University are doing this study. They want to see how people and pigs get infected with a parasite, called cysticercus (known as "pig triquina"). Cysticercus attacks the meat of pigs and the brains of people. In the intestine, the parasite is known as "solitaria". This study is to see how treatment in both people and pigs works to control the disease.
Detailed description
This is a prospective intervention study to determine the efficacy and persistence of effect over time of a single, chemotherapy intervention in both the human and porcine population. Four villages will be selected to be treated against T solium adult (in humans) and larval forms (in pigs), and two villages will receive no intervention and will serve as control villages. Pigs in control villages will be followed during 3 months only, and then the human and porcine populations will receive the intervention treatment. The effect of this intervention will be measured by the prevalence of infection in pigs and parasitic burden of infected pigs at month 3, 6, 9, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All consenting individuals older than two years living in the study villages (6 endemic communities of the Northern coast of Peru)
Key exclusion criteria (1 listed)
- Pregnancy (for antiparasitic treatment only).
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 |
|---|---|---|
| Niclosamide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Intestinal Parasitism, run by National Institute of Allergy and Infectious Diseases (NIAID) 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: stopped early, as of the sponsor's last update on 27 Aug 2010. 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 was stopped early. Results are not available in the source record.
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.
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 27 Aug 2010; AzTrials last refreshed its copy on 30 Oct 2026.