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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN15705625 |
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Date of registration:
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30/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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The effect of isoniazid preventive therapy on immune responses of household contacts with latent tuberculosis infection |
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Date of first enrolment:
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01/05/2011 |
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Target sample size:
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145 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN15705625 |
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Study type:
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Interventional |
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Study design:
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Redomised controlled trial nested within a cohort study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Irene
Andia-Biraro |
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Address:
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Department of Internal Medicine
School of Medicine
College of Health Sciences
Makerere University
P. O. Box 7072
041
Kampala
Uganda |
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Key inclusion & exclusion criteria
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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: Household contacts excluded if they have:
1. Signs and symptoms of active tuberculosis
2. Liver disease
3. Epilepsy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Latent tuberculosis infection
Infections and Infestations
Tuberculosis
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Intervention(s)
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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 were offered self-administerd isoniazid (5mg/kg to a max of 300mg) plus pyridoxine 25mg daily for six months.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Wellcome Trust Strategic Award through the Makerere University-Uganda Virus Research Institute Infection and Immunity Research Training Programme (MUII), Seventh Framework Programme
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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