A Phase 4 interventional study of Isoniazid 300Mg Tab and Isoniazid 300 MG in Latent Tuberculosis and Diabetes Mellitus, sponsored by Instituto Nacional de Salud Publica, Mexico. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Instituto Nacional de Salud Publica, Mexico · Phase 4, Interventional, and Prevention
Among 21 studies testing isoniazid in Latent Tuberculosis — 3 open to participants now, 5 under way, 1 of them phase 3. Isoniazid · Latent Tuberculosis.
Among the 21 studies testing isoniazid in Latent Tuberculosis, this one is the 21st largest by enrollment, is the only one that started in 2012, is one of 8 in phase 4, and was the 6th registered.
199 studies on the registry are indexed under Latent Tuberculosis; 48 are open to participants now.
Browse Latent Tuberculosis studies →3 of the 21 studies testing isoniazid in Latent Tuberculosis are open now, in 7 countries. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in Botswana, Haiti, Kenya and 3 more countries
Huashan Hospital · Sites in China
Miguel Santín
By country, each count listing its studies:
Isoniazid: first FDA approval 1952 (NYDRAZID). What it is approved for, and how studies give it, is on its page →
Of the 29 Latent Tuberculosis studies recruiting now, 15 (52%) set no upper age limit and 12 (41%) stop at 75 or younger; 15 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 3 · Phase 3 4 · Phase 4 8
First in 1996; this study’s year is marked. 1 started in 2012.
Median enrollment 200 across the 21 interventional studies. Of the 14 that completed or were terminated, 4 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 21 has an industry lead sponsor. The 10 most frequent:
Instituto Nacional de Salud Publica, Mexico is the lead sponsor of 31 studies on the registry; none are open to participants now.
Instituto Nacional de Salud Publica, Mexico has 4 studies filed under Latent Tuberculosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 21 studies testing isoniazid in Latent Tuberculosis, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be included to determine if the strict control of the dm achieved in clinics of the first level of attention improves clinical manifestations of tb, the result of treatment, the frequency of relapses, the mortality and the transmission to contacts.
Elispot will be used to measure TB development and the time for the bacteriological negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon, in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year: transverse study and recruitment years 2 and 3 participants' follow-ups in clinical tests(essays).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months
Drug: Isoniazid 300Mg Tab
In patients with a +TST test researchers will test for HIV, hepatic function and we will take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months
Drug: Isoniazid 300 MG
The researchers will test hepatic function and take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months
Drug: Isoniazid 300 MG
-TST tests will receive isoniazid 300Mg Tab for 6 months
Also known as: Isoniazid 300 mgs.
+ TST test will receive isoniazid 300MG Tab for 6 months
Also known as: Isoniazid
HIV positive patient will receive isoniazid 300MGTab for 6 months
Also known as: Isoniazid 300 mg per day
Development of active TB
Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB
Time frame: 6 months
No study locations are listed for this record.
The record gives a start of Sep 2012, a primary completion of Dec 2012 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Isoniazid
Instituto Nacional de Salud Publica, Mexico