Treatment of Latent Tuberculosis Infection With Isoniazid

NCT00293228 | Completed Phase 4 DMC

• 1 other identifier: 137
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the effect that treatment of dormant tuberculosis infection has on the immunological system. We expect to observe an impact over the production of cytokines by peripheral white blood cells which may be useful to know if treatment has been effective.

Conditions

Tuberculosis

Keywords

Latent tuberculosis; biomarkers; isoniazid; ELISPOT; PPD positive individuals

Outcome Measures

Primary Outcomes (1)

• Frequency of Mtb antigen-specific IFNγ-producing T cells measured by ELISPOT assay

  9 months

Secondary Outcomes (1)

• Gene expression profiling

  9 months

Study Arms (4)

A

EXPERIMENTAL

Recently converted contacts receiving isoniazid (5mg per kg up to 300 mg daily for 6 months) immediately after recruitment.

Drug: Isoniazid

B

ACTIVE COMPARATOR

B. Recently converted contacts receiving isoniazid (5mg per kg up to 300 mg daily for 6 months) three months after recruitment.

Drug: Isoniazid

C

EXPERIMENTAL

C. Remote contacts receiving isoniazid (5mg per kg up to 300 mg daily for 6 months) immediately after recruitment

Drug: Isoniazid

D

ACTIVE COMPARATOR

D. Remote contacts receiving isoniazid (5mg per kg up to 300 mg daily for 6 months) three months after recruitment.

Drug: Isoniazid

Interventions

isoniazid DRUG

Isoniazid (5mg per kg up to 300 mg daily for 6 months)

Also known as: treatment of latent tuberculosis infection

A; B; C; D

Eligibility Criteria

• Age: 10 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Age 10-45
• Either sex
• Resident in study area
• Documented TST+ve (\>10mm, Mantoux method, 2TU, PPD Statens Serum Institute)
• Normal chest radiograph
• HIV negative test

You may not qualify if:

• Active tuberculosis
• Previous diagnosis of tuberculosis
• Treatment for active or latent tuberculosis
• Contact with TB patients harboring MDR or INH resistant isolates of Mtb
• Diseases or therapies associated with immunosuppression
• Diabetes mellitus
• Abnormal liver enzyme levels.
• HB below 8gr/dl
• Pregnancy (ascertained by urinary β-HCG)
• Allergy or intolerance to isoniazid
• Peripheral neuropathy
• Ingestion of drugs interacting with isoniazid

Sponsors & Collaborators

• Instituto Nacional de Salud Publica, Mexico: lead
• Bill and Melinda Gates Foundation: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Instituto Nacional de Salud Pública

Cuernavaca, Morelos, 62508, Mexico

Location

Related Publications (3)

• Wilkinson KA, Kon OM, Newton SM, Meintjes G, Davidson RN, Pasvol G, Wilkinson RJ. Effect of treatment of latent tuberculosis infection on the T cell response to Mycobacterium tuberculosis antigens. J Infect Dis. 2006 Feb 1;193(3):354-9. doi: 10.1086/499311. Epub 2005 Dec 29.

  PMID: 16388482 BACKGROUND

• DeRiemer K, Garcia-Garcia L, Bobadilla-del-Valle M, Palacios-Martinez M, Martinez-Gamboa A, Small PM, Sifuentes-Osornio J, Ponce-de-Leon A. Does DOTS work in populations with drug-resistant tuberculosis? Lancet. 2005 Apr 2-8;365(9466):1239-45. doi: 10.1016/S0140-6736(05)74812-1.

  PMID: 15811457 BACKGROUND

• Torres M, Garcia-Garcia L, Cruz-Hervert P, Guio H, Carranza C, Ferreyra-Reyes L, Canizales S, Molina S, Ferreira-Guerrero E, Tellez N, Montero-Campos R, Delgado-Sanchez G, Mongua-Rodriguez N, Sifuentes-Osornio J, Ponce-de Leon A, Sada E, Young DB, Wilkinson RJ. Effect of isoniazid on antigen-specific interferon-gamma secretion in latent tuberculosis. Eur Respir J. 2015 Feb;45(2):473-82. doi: 10.1183/09031936.00123314. Epub 2014 Oct 30.

  PMID: 25359354 DERIVED

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lourdes Garcia-Garcia, MD

  Instituto Nacional de Salud Pública

  PRINCIPAL INVESTIGATOR

• Jose Sifuentes-Osornio, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

• Alfredo Ponce-de-Leon, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

• Eduardo Sada-Diaz, MD

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

• Martha Torres-Rojas, MD

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: February 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2009
• Last Updated: May 26, 2010

Record last verified: 2010-05

Locations

ME (1)