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
| ISRCTN | ISRCTN15705625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15705625 |
| Protocol serial number | N/A |
| Sponsor | College of Health Sciences, Makerere University |
| Funders | Wellcome Trust Strategic Award through the Makerere University-Uganda Virus Research Institute Infection and Immunity Research Training Programme (MUII), Seventh Framework Programme |
- Submission date
- 17/09/2015
- Registration date
- 30/09/2015
- Last edited
- 26/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Tuberculosis (TB) is a highly contagious bacterial infection. It is generally spread by breathing in tiny droplets released into the air by an infected person coughing or sneezing. TB usually affects the lungs, but it can also affect other areas of the body such as the bones, brain and kidneys. When a person is suffering from active TB, they are visibly unwell and can spread the infection to others. Many people however have latent TB, where the bacteria remain in an inactive state in the body. A person with latent TB has no symptoms and cannot spread the infection to others. Without treatment, the infection can become active at any time, and so monitoring people with latent TB is a vital part of controlling the spread of TB in general. Isoniazid is an antibacterial medication which has been used for many years to treat active TB infections. This drug is also commonly used to prevent active TB developing in people who have come into contact with an infected person. The aim of this study is the way that isoniazid preventative treatment (IPT) affects the body in people with latent TB, and if it can increase immunity to TB in general.
Who can participate?
Healthy people above 5 years of age, who are living with someone diagnosed with active TB.
What does the study involve?
Participants are randomly allocated into two groups. The first group receive isoniazid tablets for six months as well as attending monthly clinic visits. The second group attend monthly clinic visits only. All participants are tested for latent TB infection using a blood test at the start of the study, and then again after six months.
What are the possible benefits and risks of participating?
Participants benefit from receiving a free blood test to screen them for TB and HIV, as well as education about the medication they may be taking so that they are fully prepared for any possible side effects. Risks of participating are minimal, including pain or bruising from blood tests, as well as finding the interviews tiring.
Where is the study run from?
1. Kitebi Health Center III (Uganda)
2. Kisenyi Health Center IV (Uganda)
When is the study starting and how long is it expected to run for?
May 2011 to January 2012
Who is funding the study?
1. Seventh Framework Programme (Belgium)
2. Wellcome Trust (UK)
Who is the main contact?
Dr Irene Andia-Biraro
Contact information
Scientific
Department of Internal Medicine
School of Medicine
College of Health Sciences
Makerere University
P. O. Box 7072
Kampala
041
Uganda
 ORCID ID |
0000-0002-8303-6046 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Redomised controlled trial nested within a cohort study |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effect of isoniazid preventive therapy on immune responses of household contacts with latent tuberculosis infection |
| Study objectives | Household contacts of active tuberculosis patients with latent tuberculosis infection would present with mixed Th1/Th2 cytokine profiles and treatment of the latently infected people with isoniazid would reverses the immune equilibrium from Th2 responses back to Th1 immune dominance. |
| Ethics approval(s) | 1. The Makerere University College of Health Sciences Ethical Review Board, 10/09/2009, ref: 2009-140 2. Uganda National Council for Science and Technology, 16/09/2009, ref: HS 676 |
| Health condition(s) or problem(s) studied | Latent tuberculosis infection |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Isoniazid |
| Primary outcome measure(s) |
1. Net cytokine responses measured from Quantiferon supernatants using an 11-analyte Bio-Plex human cytokine bead array consisting of IFN-γ, IL-2, TNF-α, 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 |
| Key secondary outcome measure(s) |
1. The spontaneous cytokine responses measured from Quantiferon supernatants using an 11-analyte Bio-Plex human cytokine bead array consisting of IFN-γ, IL-2, TNF-α, 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 |
| Completion date | 20/10/2014 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 145 |
| Key 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) |
| Key exclusion criteria | Household contacts excluded if they have: 1. Signs and symptoms of active tuberculosis 2. Liver disease 3. Epilepsy |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 31/01/2012 |
Locations
Countries of recruitment
- Uganda
Study participating centres
041
Uganda
041
Uganda
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/10/2015 | Yes | No |
