HelminthiasisNCT01308268
Management of Soil-transmitted Helminthiasis and Strongyloidiasis
A study testing Ivermectin + Albendazole in people with Helminthiasis and Strongyloides Stercoralis Infection, run by Universidad Nacional de Salta at 1 site in Argentina.
Trial summary
The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a highly endemic area in northern Argentina with a multidisciplinary approach. The specific objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology method for S. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Helminthiasis, Strongyloides Stercoralis Infection
- What is being tested?
- Ivermectin + Albendazole
- How many people
- 2,000 participants
- Where
- 1 siteArgentina
- Study dates
- Dec 2010to Apr 2012
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All persons that are living in the working area at the time of the intervention and wish to participate in the study.
Who cannot join
- All persons that live within the study area but do not want to participate in the study.
- Pregnant women or women who are likely pregnant.
- Women during the first post-partum week if they are breastfeeding.
- Children who weigh less than 15 kg.
- Persons with a history of hypersensitivity or intolerance to ivermectin, albendazole or to the components that make up those drugs.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta
Orán, Salta Province, 4530
About this study
Official title: Community-based Approach for the Management of Soil-transmitted Helminthiasis in General and Strongyloidiasis in Particular in a Highly Endemic Area
The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a highly endemic area in northern Argentina with a multidisciplinary approach. The specific objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration regimen with albendazole and ivermectin.
- Conditions
- Helminthiasis, Strongyloides Stercoralis Infection
- Being tested
- Ivermectin + Albendazole
- Keywords
- STH, Soil-transmitted Helminthiasis, mass drug administration
- Medical subject headings
- Helminthiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin + AlbendazoleDrug
Ivermectin: 200µg/kg, single dose, PO + Albendazole 200 (children between 12 and 23 months) or 400 mg (>= 2 years old) single dose, PO
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy
Evaluate local epidemiology of STH: frequency of species, prevalence and intensity of infections, groups more affected, morbidity.
Evaluate the efficacy of a single-dose anti-helminthic regimen for community treatments: albendazole 400 mg + ivermectin 200 mcg/kg.
Measured: 15 months
Secondary outcomes (2)
Validate serology methods for diagnosis of S. stercoralis infection
Compare sensibility, specificity and predictive values of serology for S.stercoralis (ELISA-NIE) with traditional coproparasitological methods
Measured: 15 months
Assess the tolerability and safety of the combination of ivermectin and albendazole
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HelminthiasisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Salta
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mundo Sano, Albert B. Sabin Vaccine Institute
- Investigators
- Alejandro Krolewiecki, MD, PhD, Principal investigator, Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308268
- Sponsor's protocol ID
- IIET-05
- Status last verified
- Feb 2011
- First submitted
- 3 Mar 2011
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Approach for the Management of Soil-transmitted Helminthiasis in General and Strongyloidiasis in Particular in a Highly Endemic Area
- ClinicalTrials.gov ID
- NCT01308268
- Acronym / sponsor ID
- IIET-05
- Conditions
- Helminthiasis, Strongyloides Stercoralis Infection
- Keywords
- STH, Soil-transmitted Helminthiasis, mass drug administration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Universidad Nacional de SaltaUniversity, hospital or other
- Collaborators
- Fundación Mundo Sano, Albert B. Sabin Vaccine Institute
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 4 Mar 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 general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a highly endemic area in northern Argentina with a multidisciplinary approach. The specific objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration regimen with albendazole and ivermectin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All persons that are living in the working area at the time of the intervention and wish to participate in the study.
Key exclusion criteria (5 listed)
- All persons that live within the study area but do not want to participate in the study.
- Pregnant women or women who are likely pregnant.
- Women during the first post-partum week if they are breastfeeding.
- Children who weigh less than 15 kg.
- Persons with a history of hypersensitivity or intolerance to ivermectin, albendazole or to the components that make up those drugs.
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 |
|---|---|---|
| Ivermectin + AlbendazoleIvermectin: 200µg/kg, single dose, PO + Albendazole 200 (children between 12 and 23 months) or 400 mg (>= 2 years old) single dose, PO | Drug | – |
Primary outcome
Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy
Time frame: 15 months
Evaluate local epidemiology of STH: frequency of species, prevalence and intensity of infections, groups more affected, morbidity. Evaluate the efficacy of a single-dose anti-helminthic regimen for community treatments: albendazole 400 mg + ivermectin 200 mcg/kg.
2 secondary outcomes
Validate serology methods for diagnosis of S. stercoralis infection
Time frame: 15 months
Assess the tolerability and safety of the combination of ivermectin and albendazole
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
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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.
Alejandro Krolewiecki, MD, PhD principal investigator
Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivermectin + Albendazole in people with Helminthiasis and Strongyloides Stercoralis Infection, run by Universidad Nacional de Salta at 1 site in Argentina.
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 5 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 4 Mar 2011. 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 Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Krolewiecki, MD, PhD (+54-11-45531369, alekrol@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy (time frame: 15 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 4 Mar 2011.