NCT01296958

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,811

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

1.7 years

First QC Date

February 15, 2011

Last Update Submit

October 22, 2014

Conditions

Taenia Solium Taeniasis

Keywords

Taenia soliumcysticercosisneurocysticercosis

Outcome Measures

Primary Outcomes (1)

  • Porcine seroprevalence

    Every 4 months

Secondary Outcomes (1)

  • Intestinal tapeworm prevalence

    16 months

Study Arms (2)

Targeted screening

EXPERIMENTAL

Screening for intestinal tapeworm carrier followed by treatment with niclosamide as indicated.

Drug: Niclosamide

Education

ACTIVE COMPARATOR

Community education about Taenia solium prevention.

Behavioral: Community education campaign

Interventions

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)

Targeted screening
Community education campaignBEHAVIORAL

Education about prevention of Taenia solium infection provided in a single short (20 minute) interaction with the participant. Education was verbal with visual aids.

Education

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All community members are eligible

You may not qualify if:

  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Marcos University

Lima, Peru

Location

MeSH Terms

Conditions

TaeniasisCysticercosisNeurocysticercosis

Interventions

Niclosamide

Condition Hierarchy (Ancestors)

Cestode InfectionsHelminthiasisParasitic DiseasesInfectionsCentral Nervous System HelminthiasisCentral Nervous System Parasitic InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SalicylanilidesAnilidesAmidesOrganic ChemicalsSalicylamidesAniline CompoundsAmines

Study Officials

  • Seth E ONeal, MD MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Armando Gonzalez, DVM PhD

    San Marcos University School of Veterinary Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 16, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

PE(1)