NCT01547884

Brief Summary

Background: \- Lymphatic filariasis is an infection that is caused by small, thread-like worms. It is spread by mosquitoes, and causes fever, chills, and headaches. If untreated, it can also cause elephantiasis, a condition that leads to swelling of the arms, legs, breasts, and scrotum. Treatment can eliminate the worms from the blood and reduce the risk of developing elephantiasis. Researchers want to study people with latent tuberculosis (TB) who may or may not be infected with filariasis. This study will look at the way that people with latent TB fight infection with these worms. Objectives: \- To study how the immune systems of people with latent TB react to filarial infection. Eligibility: \- Individuals between 18 and 65 years of age who have latent TB and may or may not have filarial infection. Design:

  • Participants will be screened with a physical exam and medical history. They will provide a blood and stool sample to test for infection.
  • Participants who do not have lymphatic filariasis but have another kind of intestinal worm will be treated for the parasite. This will be their last study visit.
  • Participants who have latent TB and lymphatic filariasis will be treated with the standard treatment for the disease. They will come back for a second visit 6 months later, and will provide another blood sample.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
4,268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

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

March 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2020

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

6.9 years

First QC Date

March 6, 2012

Last Update Submit

April 19, 2021

Conditions

Mycobacterium InfectionsTuberculosisFilariasisLatent Tuberculosis

Keywords

T CellsImmune ResponsesMycobacterial AntigensTissue-invasive Helminth ParasitesCytokines

Outcome Measures

Primary Outcomes (1)

  • To compare the immune responses to mycobacterial antigens, including PPD and Mycobacterium tuberculosis culture filtrate protein, in individuals who are LTBI+ Hel- versus those who are LTBI+Hel+

    pending

    5 years

Secondary Outcomes (1)

  • To compare immune responses to mycobacterial antigens in LTBI+ Hel+ co- infected individuals, before and after treatment for filarialinfection.

    5 years

Study Arms (2)

1

Latent TB positive with helminth positive

2

Latent TB positive with helminth negative

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The screening will be a community-based study in South India. Study participants will be recruited from villages in the Kancheepuram District, where approximately 6% of the population tests positive for circulating filarial antigens \[31\]. PPD skin test reactivity in this population is virtually 100% to PPD-B (battery) and 60% to 70% to PPD-S (standard) by age 24, and the incidence of active TB is about 4 per 1000 individuals \[31\]. While the rate of positivity of the tuberculin skin test to the 2TU PPD test is not known, significant deviation in the percent positivity from skin tests using 1TU is not expected based on findings reported elsewhere \[32\]. However, we are revising the @@@screening sample number on the basis of preliminary data from the current study that shows that the prevalence of latent TB in this population is around 25% and filariasis is around 1%. In addition, preliminary data from these areas show that the prevalence of Stronglyloides infection is around 10%.

You may qualify if:

  • Individuals (18 to 65 years of age) who meet the following criteria are eligible to participate in the study:
  • Positive tuberculin PPD skin test result (\>or equal to 5 mm) and IGRA+.
  • Willingness to provide blood and stool samples for examination.
  • Willingness to have samples stored for study participants only.

You may not qualify if:

  • Individuals are not eligible to participate if:
  • Pulmonary symptoms suggestive of TB (cough \>3 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis).
  • Tuberculin skin test within the last 6 months prior to screening.
  • Women who are pregnant or breastfeeding.
  • Known documented cases of cancer, acquired immune deficiency syndrome, or other immunosuppressive illness.
  • History of any other illness or condition which, in the investigator s judgment, may substantially increase the risk associated with the subject s participation in the protocol, or it may compromise the scientific objectives.
  • Consumption of DEC in the last one year prior to screening.
  • Pregnancy: Pregnant and lactating women will be excluded from the study because the safety of DEC or ivermectin has not been adequately evaluated during pregnancy or lactation, while albendazole is a Category C drug found to be teratogenic in animals, and it poses a potential risk during breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi

Bethesda, Maryland, 20892, United States

Location

Nih-Nirt Icer

Chennai, India

Location

Related Publications (3)

  • Metenou S, Babu S, Nutman TB. Impact of filarial infections on coincident intracellular pathogens: Mycobacterium tuberculosis and Plasmodium falciparum. Curr Opin HIV AIDS. 2012 May;7(3):231-8. doi: 10.1097/COH.0b013e3283522c3d.

    PMID: 22418448BACKGROUND

  • Babu S, Nutman TB. Helminth-Tuberculosis Co-infection: An Immunologic Perspective. Trends Immunol. 2016 Sep;37(9):597-607. doi: 10.1016/j.it.2016.07.005. Epub 2016 Aug 5.

    PMID: 27501916BACKGROUND

  • Salgame P, Yap GS, Gause WC. Effect of helminth-induced immunity on infections with microbial pathogens. Nat Immunol. 2013 Nov;14(11):1118-1126. doi: 10.1038/ni.2736.

    PMID: 24145791BACKGROUND

MeSH Terms

Conditions

Mycobacterium InfectionsTuberculosisFilariasisLatent Tuberculosis

Condition Hierarchy (Ancestors)

Actinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesLatent Infection

Study Officials

  • Thomas B Nutman, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 8, 2012

Study Start

January 1, 2013

Primary Completion

November 14, 2019

Study Completion

August 7, 2020

Last Updated

April 20, 2021

Record last verified: 2021-04

Locations

IN(1)US(1)