The role of isoniazid medication in preventing progression to active tuberculosis disease in persons with latent tuberculosis: The effect on the body’s immune system

The effect of isoniazid preventive therapy on immune responses of household contacts with latent tuberculosis infection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15705625

Enrollment

145

Registered

2015-09-30

Start date

2011-05-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Latent tuberculosis infection Infections and Infestations Tuberculosis

Interventions

Household contacts that were eligible for the study were randomized to receive either isoniazid preventive therapy (IPT) and monthly visits or monthly visits only. Household contacts in the IPT arm we

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Household contacts exposed to patients with sputum smear positive tuberculosis that are: 1. Above the age of 5 years 2. HIV negative 3. Tested positive on both the tuberculin skin test and the QuantiFERON®-TB Gold In-Tube® test (Cellestis GmbH (Europe), Hannover, Germany; QFN)

Exclusion criteria

Exclusion criteria: Household contacts excluded if they have: 1. Signs and symptoms of active tuberculosis 2. Liver disease 3. Epilepsy

Design outcomes

Primary

Measure	Time frame
1. Net cytokine responses measured from Quantiferon supernatants using an 11-analyte Bio-Plex human cytokine bead array consisting of IFN-?, IL-2, TNF-a, IL-4, IL-5, IL-13, IL-10, IL-17a, IL-17f, IL-21, and IL-22, among the household contacts at the end of six-months follow up 2. Mtb specific antibody concentrations to purified protein derivative (PPD), culture filtrate protein 10 (CFP-10), early secreted antigenic target 6 (ESAT-6) antigens using an in-house IgG ELISA assay, among the household contacts at the end of six-months follow up	—

Measure

Time frame

1. Net cytokine responses measured from Quantiferon supernatants using an 11-analyte Bio-Plex human cytokine bead array consisting of IFN-?, IL-2, TNF-a, IL-4, IL-5, IL-13, IL-10, IL-17a, IL-17f, IL-21, and IL-22, among the household contacts at the end of six-months follow up 2. Mtb specific antibody concentrations to purified protein derivative (PPD), culture filtrate protein 10 (CFP-10), early secreted antigenic target 6 (ESAT-6) antigens using an in-house IgG ELISA assay, among the household contacts at the end of six-months follow up

—

Secondary

Measure	Time frame
1. The spontaneous cytokine responses measured from Quantiferon supernatants using an 11-analyte Bio-Plex human cytokine bead array consisting of IFN-?, IL-2, TNF-a, IL-4, IL-5, IL-13, IL-10, IL-17a, IL-17f, IL-21, and IL-22 at the end of six-months follow up 2. Any side effects due to IPT found during clinical assessment at each monthly clinic visit or reported as they occur 3. Any changes in TST and QFN test reactions between baseline and at the end of six-months follow up 4. Incidence of active TB acquired during the course of the six-months follow up	—

Measure

Time frame

1. The spontaneous cytokine responses measured from Quantiferon supernatants using an 11-analyte Bio-Plex human cytokine bead array consisting of IFN-?, IL-2, TNF-a, IL-4, IL-5, IL-13, IL-10, IL-17a, IL-17f, IL-21, and IL-22 at the end of six-months follow up 2. Any side effects due to IPT found during clinical assessment at each monthly clinic visit or reported as they occur 3. Any changes in TST and QFN test reactions between baseline and at the end of six-months follow up 4. Incidence of active TB acquired during the course of the six-months follow up

—

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026