Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE4
Total Enrollment
467 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-04
Study Completion Date
2019-08-10
Brief Summary
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The purpose of this study is to determine if the isoniazid is effective in the prevention of tuberculosis in a prison population, exposed to the high endemicity of the disease.
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Detailed Description
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Despite being a known disease of mankind over 9000 years, tuberculosis (TB) is still a major public health problem in developing countries, mainly due to so-called highly endemic sites, such as prisons.
It is Infectious disease, with airborne transmission, TB can present both the active or latent form. Despite the biological aspect of transmission, unhealthy environmental conditions (room without direct sunlight, poor ventilation and overcrowded) and individual factors (malnutrition, immunosuppression, use of alcohol and other drugs) have significant influence on transferability and infectivity.
With the discovery of drugs active against Mycobacterium tuberculosis, it was observed a reduction of disease incidence in the world. Despite this declining incidence, World Health Organization (WHO) classifies TB as a public health problem due to the emergence of multidrug strains or extensively resistant to treatment, added to the cases of latent TB reactivation, observed with the advent of HIV/AIDS.
Studies show a direct relationship between the incidence of TB and the prison environment. Nevertheless, the presence of prisons in one location increases the incidence of this disease, indicating that there is an exchange of disease between the prison and the community.
Currently, control of TB in the prison system is based on the tracking of individuals with active TB and / or latent and, in their respective treatment. For the identification of individuals with active disease, it is necessary the recognition of respiratory symptoms (cough mainly) and sputum smear microscopy and sputum culture, and chest X-ray. As the search of individuals with latent form, must be carried to the skin test with Purified Protein Derived (PPD).
Most of the units of the Brazilian's prison system these diagnostic methods are not available and hence the transport of individuals for their realization is necessary, generating an additional cost, in most cases, unfeasible process execution.
With the completion of this study, it seek to determine the effectiveness of primary prophylaxis in the prison population in order to gather new scientific evidence, to bring affordable methods for the control of TB in prisons.
Despite advances in diagnosis and treatment TB, this is the third leading cause of death from infectious diseases worldwide (Naghavi et al, 2015). In 2015, the WHO estimated incidence of 9.6 million new cases of TB in the world, with about 1.1 million deaths. For Brazil it was estimated incidence of 44 cases per 100,000 (WHO, 2015). The incidence of TB has declined about 2% per year, but this rate is not homogeneous in the global context.
Brazil occupies the 22nd place in the ranking of the WHO with an estimated annual rate of 83,310 cases of the disease (Zumla et al, 2015). In the past seven years, it is estimated that the incidence declined only 0.7% (per year). A key factor in this slow progress in TB control in Brazil, and other emerging countries is the existence of high-risk subpopulations, including slums and prisons, which act as reservoirs and amplifiers for the transmission of the disease (Basu; Stückler; Mckee 2011; Dowdy et al, 2012). A recent systematic review showed that the average incidence of TB in the prison population can be up to 23 times that recorded in the general population (Baussano et al, 2010).
With the fourth largest prison populations in the world, is observed in Brazil, the increased incidence of TB among prisoners in the last seven years. Although prisoners represent only 0.3% of the population, the increase in the prison population over this period resulted in almost doubling the proportion of all TB cases that occur among prisoners (4.1% in 2007, 8, 1% in 2013).
The arrests are in an ideal environment for the spread of TB, since they show individuals users of tobacco and alcohol in high doses, in addition to drug abuse in overcrowded cells with poor ventilation and with limited access to care health and diagnosis of TB. Currently, the Ministry of Health recommends active search for TB at the entrance to the prison and once a year by chest X-ray. Due to the cost and logistics, most prisons do not adhere to this recommendation. There is also a clear recommendation not to use the tuberculin skin test or perform the treatment for latent tuberculosis. If the procedures for active case detection and / or prophylactic treatment would impact the high transmission in prisons is a question that still remains open (Al-Darraji; Kamarulzamn; Altice, 2012).
The concentration of cases of TB in prisons can represent both an obstacle and an opportunity to control the disease, depending on the effectiveness of interventions in these environments.
Preliminary studies show high annual rate of TB infection (26%) among the prison population of 12 penitentiaries of Mato Grosso do Sul. Besides the large burden of disease in this population is significant dispersion of the TB prison to the community (Sacchi et al, 2015). Cross-sectional studies show high yield annual screening for TB, however, the effectiveness of this measure combined with other interventions remains unclear (Ferreira et al, 1996; Fournet et al, 2006; Lemos et al, 2014; Vieira et al, 2010; Sanches et al, 2013; Walnut; Abrahão; Galesi, 2012; Kuhleis et al, 2012; Estevan; Oliveira; Croda, 2013). Due to the combination of high force of infection in prisons and short prison term, primary prophylaxis may be an effective intervention. This new approach has never been evaluated in the context of prisons in low and middle income countries; to assess the impact of program strategies for TB screening and prophylaxis, longitudinal data will be essential. Given the infrastructure that was created for long-term prospective studies in Brazil, there is an excellent opportunity to close the critical knowledge gaps that have been barriers to effective implementation of TB control in high transmission prisons.
It is Infectious disease, with airborne transmission, TB can present both the active or latent form. Despite the biological aspect of transmission, unhealthy environmental conditions (room without direct sunlight, poor ventilation and overcrowded) and individual factors (malnutrition, immunosuppression, use of alcohol and other drugs) have significant influence on transferability and infectivity.
With the discovery of drugs active against Mycobacterium tuberculosis, it was observed a reduction of disease incidence in the world. Despite this declining incidence, World Health Organization (WHO) classifies TB as a public health problem due to the emergence of multidrug strains or extensively resistant to treatment, added to the cases of latent TB reactivation, observed with the advent of HIV/AIDS.
Studies show a direct relationship between the incidence of TB and the prison environment. Nevertheless, the presence of prisons in one location increases the incidence of this disease, indicating that there is an exchange of disease between the prison and the community.
Currently, control of TB in the prison system is based on the tracking of individuals with active TB and / or latent and, in their respective treatment. For the identification of individuals with active disease, it is necessary the recognition of respiratory symptoms (cough mainly) and sputum smear microscopy and sputum culture, and chest X-ray. As the search of individuals with latent form, must be carried to the skin test with Purified Protein Derived (PPD).
Most of the units of the Brazilian's prison system these diagnostic methods are not available and hence the transport of individuals for their realization is necessary, generating an additional cost, in most cases, unfeasible process execution.
With the completion of this study, it seek to determine the effectiveness of primary prophylaxis in the prison population in order to gather new scientific evidence, to bring affordable methods for the control of TB in prisons.
Despite advances in diagnosis and treatment TB, this is the third leading cause of death from infectious diseases worldwide (Naghavi et al, 2015). In 2015, the WHO estimated incidence of 9.6 million new cases of TB in the world, with about 1.1 million deaths. For Brazil it was estimated incidence of 44 cases per 100,000 (WHO, 2015). The incidence of TB has declined about 2% per year, but this rate is not homogeneous in the global context.
Brazil occupies the 22nd place in the ranking of the WHO with an estimated annual rate of 83,310 cases of the disease (Zumla et al, 2015). In the past seven years, it is estimated that the incidence declined only 0.7% (per year). A key factor in this slow progress in TB control in Brazil, and other emerging countries is the existence of high-risk subpopulations, including slums and prisons, which act as reservoirs and amplifiers for the transmission of the disease (Basu; Stückler; Mckee 2011; Dowdy et al, 2012). A recent systematic review showed that the average incidence of TB in the prison population can be up to 23 times that recorded in the general population (Baussano et al, 2010).
With the fourth largest prison populations in the world, is observed in Brazil, the increased incidence of TB among prisoners in the last seven years. Although prisoners represent only 0.3% of the population, the increase in the prison population over this period resulted in almost doubling the proportion of all TB cases that occur among prisoners (4.1% in 2007, 8, 1% in 2013).
The arrests are in an ideal environment for the spread of TB, since they show individuals users of tobacco and alcohol in high doses, in addition to drug abuse in overcrowded cells with poor ventilation and with limited access to care health and diagnosis of TB. Currently, the Ministry of Health recommends active search for TB at the entrance to the prison and once a year by chest X-ray. Due to the cost and logistics, most prisons do not adhere to this recommendation. There is also a clear recommendation not to use the tuberculin skin test or perform the treatment for latent tuberculosis. If the procedures for active case detection and / or prophylactic treatment would impact the high transmission in prisons is a question that still remains open (Al-Darraji; Kamarulzamn; Altice, 2012).
The concentration of cases of TB in prisons can represent both an obstacle and an opportunity to control the disease, depending on the effectiveness of interventions in these environments.
Preliminary studies show high annual rate of TB infection (26%) among the prison population of 12 penitentiaries of Mato Grosso do Sul. Besides the large burden of disease in this population is significant dispersion of the TB prison to the community (Sacchi et al, 2015). Cross-sectional studies show high yield annual screening for TB, however, the effectiveness of this measure combined with other interventions remains unclear (Ferreira et al, 1996; Fournet et al, 2006; Lemos et al, 2014; Vieira et al, 2010; Sanches et al, 2013; Walnut; Abrahão; Galesi, 2012; Kuhleis et al, 2012; Estevan; Oliveira; Croda, 2013). Due to the combination of high force of infection in prisons and short prison term, primary prophylaxis may be an effective intervention. This new approach has never been evaluated in the context of prisons in low and middle income countries; to assess the impact of program strategies for TB screening and prophylaxis, longitudinal data will be essential. Given the infrastructure that was created for long-term prospective studies in Brazil, there is an excellent opportunity to close the critical knowledge gaps that have been barriers to effective implementation of TB control in high transmission prisons.
Conditions
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Tuberculosis, Pulmonary
Antibiotic Prophylaxis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Treatment
Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
Group Type
EXPERIMENTAL
Isoniazid 900 milligrams
Intervention Type
DRUG
Oral tablet, with the isoniazid 900mg, given two weekly. The administration will be supervised.
Control
Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Oral tablet, without the active ingredient, similar in size, weight, color, taste and odor.
Interventions
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Isoniazid 900 milligrams
Oral tablet, with the isoniazid 900mg, given two weekly. The administration will be supervised.
Intervention Type
DRUG
Placebo
Oral tablet, without the active ingredient, similar in size, weight, color, taste and odor.
Intervention Type
DRUG
Other Intervention Names
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Antibiotic Treatment
Placebo Treatment
Eligibility Criteria
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Inclusion Criteria
* Age above 18 and under 45 at the time of inclusion;
* Sign the informed consent form.
* Sign the informed consent form.
Exclusion Criteria
* Be indigenous;
* Active TB or previous use of isoniazid;
* Score Alcohol Use Disorders Identification Test ≥15.
* Reactive serology for HIV, hepatitis B and C;
* Reactive result for quantiferon, considering as positive the result of Tube 1 and / or Tube22 above 0.2 IU / mL;
* Liver enzymes (Aspartate aminotransferase and Alanate aminotransferase) three times the upper limit;
* History or treatment for epilepsy;
* Active TB or previous use of isoniazid;
* Score Alcohol Use Disorders Identification Test ≥15.
* Reactive serology for HIV, hepatitis B and C;
* Reactive result for quantiferon, considering as positive the result of Tube 1 and / or Tube22 above 0.2 IU / mL;
* Liver enzymes (Aspartate aminotransferase and Alanate aminotransferase) three times the upper limit;
* History or treatment for epilepsy;
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
Yes
Sponsors
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Oswaldo Cruz Foundation
OTHER
Sponsor Role
collaborator
Federal University of Mato Grosso
OTHER
Sponsor Role
lead
Responsible Party
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Roberto D Oliveira
PhD Student
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Flora MF Moreira, Graduate
Role: STUDY_CHAIR
MsC Student
Andrea SS Carbone, MsC
Role: STUDY_CHAIR
PhD student
Flavia PC Sacchi, MsC
Role: STUDY_CHAIR
PhD student
Paulo CP Santos, Graduate
Role: STUDY_CHAIR
MsC Student
Rafaele CP Araújo, MsC
Role: STUDY_CHAIR
PhD student
Alessandra C Leite, MsC
Role: STUDY_CHAIR
PhD student
Cassia B Reis, PhD
Role: STUDY_CHAIR
Pos doc Student
Valeria C Rolla, PhD
Role: STUDY_CHAIR
Professor
Jason R Andrews, PhD
Role: STUDY_CHAIR
Professor
Locations
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Roberto Oliveira
Dourados, Mato Grosso do Sul, Brazil
Site Status
Countries
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Brazil
References
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BACKGROUND
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Kuhleis D, Ribeiro AW, Costa ER, Cafrune PI, Schmid KB, Costa LL, Ribeiro MO, Zaha A, Rossetti ML. Tuberculosis in a southern Brazilian prison. Mem Inst Oswaldo Cruz. 2012 Nov;107(7):909-15. doi: 10.1590/s0074-02762012000700012.
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GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.
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Sacchi FP, Praca RM, Tatara MB, Simonsen V, Ferrazoli L, Croda MG, Suffys PN, Ko AI, Andrews JR, Croda J. Prisons as reservoir for community transmission of tuberculosis, Brazil. Emerg Infect Dis. 2015 Mar;21(3):452-5. doi: 10.3201/eid2103.140896.
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Sanchez A, Massari V, Gerhardt G, Espinola AB, Siriwardana M, Camacho LA, Larouze B. X ray screening at entry and systematic screening for the control of tuberculosis in a highly endemic prison. BMC Public Health. 2013 Oct 20;13:983. doi: 10.1186/1471-2458-13-983.
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Vieira AA, Ribeiro SA, de Siqueira AM, Galesi VM, dos Santos LA, Golub JE. Prevalence of patients with respiratory symptoms through active case finding and diagnosis of pulmonary tuberculosis among prisoners and related predictors in a jail in the city of Carapicuiba, Brazil. Rev Bras Epidemiol. 2010 Dec;13(4):641-50. doi: 10.1590/s1415-790x2010000400009.
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Barrera, L. The basics of clinical bacteriology Tuberculosis (2007): 93-112.
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Daniel TM. The history of tuberculosis. Respir Med. 2006 Nov;100(11):1862-70. doi: 10.1016/j.rmed.2006.08.006. Epub 2006 Sep 1.
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Porter JD, McAdam KP. The re-emergence of tuberculosis. Annu Rev Public Health. 1994;15:303-23. doi: 10.1146/annurev.pu.15.050194.001511.
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Nunn P, Williams B, Floyd K, Dye C, Elzinga G, Raviglione M. Tuberculosis control in the era of HIV. Nat Rev Immunol. 2005 Oct;5(10):819-26. doi: 10.1038/nri1704.
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Schluger NW, Rom WN. The host immune response to tuberculosis. Am J Respir Crit Care Med. 1998 Mar;157(3 Pt 1):679-91. doi: 10.1164/ajrccm.157.3.9708002. No abstract available.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
http://www.prisonstudies.org/country/brazil
World Prison Brief: Brazil.
https://www.sealedenvelope.com/power/binary-superiority
Power calculator for binary outcome superiority trial.
Other Identifiers
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U1111-1189-0829
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE3
Intervention in the Management of Post-high Tuberculosis Hospital Through Educational Strategy and Oversight Distance
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COMPLETED
NA
Treatment of Latent Tuberculosis Infection With Isoniazid
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COMPLETED
PHASE4
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
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TERMINATED
PHASE2
Research on New Regimens for Retreatment Pulmonary Tuberculosis
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UNKNOWN
PHASE4
A Multiple Ascending Dose Study With a Dose Formulation Comparison Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
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TERMINATED
PHASE1
Tuberculosis Screening in Paraguayan Prisons
NCT04407325
UNKNOWN
NA
A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis
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COMPLETED
PHASE3
Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation
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COMPLETED
PHASE4
Improving the Diagnostic of Tuberculosis
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COMPLETED
NA
Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis
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WITHDRAWN
PHASE4
A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
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COMPLETED
PHASE1
Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus
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RECRUITING
PHASE3
Phase 2a Study of PBTZ169
NCT03334734
TERMINATED
PHASE2
Phase 2 Study of the ТВ/Flu-05Е Tuberculosis Vaccine
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COMPLETED
PHASE2
Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets
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COMPLETED
TBTC Study 24: Intermittent Treatment of TB With Isoniazid Resistance or Intolerance
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COMPLETED
NA
Tuberculosis - Learning the Impact of Nutrition
NCT03598842
COMPLETED
NA
Study on Three Doses of an Inactivated COVID-19 Vaccine in Chinese Pulmonary Tuberculosis Patients
NCT05148949
UNKNOWN
PHASE4
Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis
NCT02901288
UNKNOWN
PHASE4
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
NCT03251196
UNKNOWN
The Optimal Duration of Preoperative Anti-tuberculosis Treatment of Spinal Tuberculosis
NCT02477852
UNKNOWN
PHASE4
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2556286 in Healthy Adult Participants
NCT04472897
TERMINATED
PHASE1
Metronidazole for Pulmonary Tuberculosis (South Korea)
NCT00425113
COMPLETED
PHASE2