NCT03605758

Brief Summary

The aim of this study is to evaluate the serologic response in patients with S. stercoralis infection after treatment with a regimen of two single doses of 200 µg/kg of ivermectin given 2 weeks apart versus a regimen of two single doses of 200 µg/kg of ivermectin given in two consecutive days.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

November 30, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

July 23, 2018

Results QC Date

November 2, 2023

Last Update Submit

November 28, 2023

Conditions

Strongyloides Stercoralis InfectionStrongyloidiasis

Keywords

IvermectinS. stercoralisparasitehelminthFilariformlarvaeBaermann technique

Outcome Measures

Primary Outcomes (3)

  • Level of Strongyloides Serology as Measured by ELISA at 3-4 Months Post-treatment

    The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. \>0.3 OD (optical density) means positive for infection while \<0.29 OD means negative (no infection).

    3-4 months post treatment

  • Level of Strongyloides Serology as Measured by ELISA at 6-8 Months Post-treatment

    The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. \>0.3 OD (optical density) means positive for infection while \<0.29 OD means negative (no infection).

    6-8 months post treatment

  • Level of Strongyloides Serology as Measured by ELISA at 9-12 Months Post-treatment

    The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. \>0.3 OD (optical density) means positive for infection while \<0.29 OD means negative (no infection).

    9-12 months post treatment

Study Arms (2)

Ivermectin on Days 1 and 2

ACTIVE COMPARATOR

Participants will receive 200 µg/kg of ivermectin daily for two consecutive days with breakfast.

Drug: Ivermectin

Ivermectin on Days 1 and 14

ACTIVE COMPARATOR

Participants will receive 200 µg/kg of ivermectin on day one and day 14 with breakfast.

Drug: Ivermectin

Interventions

IvermectinDRUG

Ivermectin is an anti-parasitic

Also known as: Stromectol
Ivermectin on Days 1 and 14Ivermectin on Days 1 and 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Positive for Strongyloides serology infection (as determined by ELISA)

You may not qualify if:

  • Severe intestinal Strongyloides infection
  • Disseminated Strongyloidiasis infection
  • Pregnant and breastfeeding women
  • HTLV-1 co-infection
  • Patients with indeterminate results on Strongyloides serology
  • Patients who are immunosuppressed
  • Unable to read and understand consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Strongyloidiasis

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Rhabditida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Dr. Christina Coyle
Organization
Albert Einstein College of Medicine
christina.coyle@einsteinmed.edu
718-430-3525

Study Officials

  • Christina M Coyle, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

July 30, 2018

Study Start

May 1, 2012

Primary Completion

February 5, 2015

Study Completion

February 5, 2015

Last Updated

November 30, 2023

Results First Posted

November 30, 2023

Record last verified: 2023-11

Locations

US(1)