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Silicosis clinical trials

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NCT ID: NCT06403800 Recruiting - Tuberculosis Clinical Trials

Silicosis and Silicotuberculosis Among Small Scale Gemstone Miners in Northern Tanzania

SilicoTB
Start date: March 11, 2024
Phase:
Study type: Observational

Artisanal, small-scale mining (ASM) is a large and essential component of the world's economy. Despite attendant risks, there is little research into risks to the health of artisanal miners. The tanzanite gemstone is mined exclusively in Northern Tanzania, in deep shafts using ASM techniques. There is concerning evidence that the burden of silicosis and tuberculosis (TB) amongst miners is high. In addition to miners' personal risks, there is concern that a high rate of silicotuberculosis may hamper community control of TB. Our primary aim is to measure the rate of silicosis progression among tanzanite miners. Our secondary aims include measuring the prevalence of TB among miners, describing TB transmission patterns in miners and the community, and assessing rates of 'catastrophic' economic loss amongst miners. To do this, the investigators propose two studies. First, the investigators will establish a prospective cohort of 410 small scale tanzanite miners and record symptoms, respiratory function including spirometry, chest radiography, and prevalence of TB and Human Immunodeficiency Virus (HIV) infection over an 18-month period. Second, the investigators will utilize an ongoing community-based TB screening program to perform a cross-sectional survey of TB prevalence among miners and community members. To assess TB transmission, the investigators will collect epidemiological data and perform whole genome sequencing (WGS) on positive Mycobacterium tuberculosis (MTb) culture samples. Given the lack of research and large global ASM workforce, 1 million of whom are in Tanzania, the results of this study will assist in the development and introduction of interventions to reduce the risks to respiratory health of artisanal mining in Tanzania and elsewhere; and provide ample scope for future work.

NCT ID: NCT06090370 Recruiting - Silicosis Clinical Trials

Reducing Silica Exposure Among Brick Kiln Workers in Nepal

Start date: January 24, 2024
Phase: N/A
Study type: Interventional

Inhaling respirable silica increases the risk for silicosis, an incurable and debilitating lung disease. In South Asia, one high-risk industry is brick manufacturing, where more than 4 million manual laborers mold bricks by hand. In Nepal, brick manufacturing employs over 200,000 workers across 1,200 registered brick kilns. These workers are exposed to respirable silica concentrations 1.4 to 6.6 times higher than the limits set by the U.S. National Institute for Occupational Safety and Health. Preventing silicosis is paramount, as the average brick kiln worker cannot afford medical care and only 6.8% receive regular health checks. Few studies have evaluated interventions in brick kiln workers to reduce silica exposure and prevent silicosis. One promising intervention involves providing workers who are exposed to silica above the permissible exposure limit with personal protective equipment (PPE), specifically respirators. When properly used, respirators decrease silica inhalation and the risk of silicosis. Brick kiln workers in Nepal do not use any PPE. Several studies have explored PPE barriers and have evaluated the feasibility of implementing PPE but to date none have been conducted in Nepali brick kiln workers. To close this gap, the goal of this research is a human-centered design approach to develop and pilot a PPE training program in one brick kiln in Nepal guided by the Discover, Design, Build, and Test (DDBT) framework. This research is necessary to understand the Nepali context and to efficiently develop appropriate and feasible PPE intervention components that will be trialed in future research.

NCT ID: NCT05546944 Recruiting - Silicosis Clinical Trials

The SHIELD Study-silicosis

Start date: August 16, 2022
Phase:
Study type: Observational [Patient Registry]

An observational cohort study to derive biomarkers which are able to more accurately diagnose silicosis, as well as predict disease progression, assess response to treatment, and hasten therapeutic discovery.

NCT ID: NCT05538299 Recruiting - Silicosis Clinical Trials

Silicosis Treatment, Action, Screening and Surveillance in Rwanda Trials

STARSS
Start date: July 31, 2022
Phase:
Study type: Observational [Patient Registry]

Silicosis is the most prevalent occupational lung disease in low- and middle-income countries (LMICs) with "tens of millions" estimated to suffer from the disease according to the World Health Organization (WHO). To date, there is little published data on silicosis in LMICs and the burden of silicosis in Rwanda has not been well-defined. Silicosis among local mine workers is a common reason for hospitalization and death at Rwinkwavu District Hospital, located in Rwanda's Kayonza District. The objectives of this study are: 1. To assess the prevalence of silicosis among workers in four mines located in the Kayonza District of Rwanda 2. To adapt a validated screening tool testing in Dutch construction workers for Rwandan miners 3. To implement an occupational health education program and assess the change of before and after intervention that target towards proper use of PPE and individual risk assessment in mine workers using knowledge-attitudes-practice tool

NCT ID: NCT05118256 Recruiting - Silicosis Clinical Trials

Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis

Start date: November 15, 2021
Phase: Phase 2
Study type: Interventional

Silicosis is one of the leading causes of occupational respiratory disease worldwide. It is due to inhalation of respirable crystalline silica and can lead to progressive massive fibrosis (PMF), respiratory failure, and death. It is estimated that it causes more than 10,000 deaths a year worldwide, mainly in developing countries, although the level of underdiagnosis is high. In developed countries the incidence of the disease has been progressively decreasing in recent years, mainly due to the implementation of effective prevention measures, better occupational health surveillance systems and the displacement of mining activity to other countries, in a way that in the United Kingdom 216 cases were reported from 1996 to 2017. At the moment, there is no curative treatment for the disease, and the only therapeutic option is lung transplantation (when the disease evolves to PMF and subsequent respiratory failure). Meanwhile, the only accepted treatment is supportive treatment, with the administration of oxygen therapy in case of respiratory failure, early treatment of respiratory infections, vaccinations and respiratory rehabilitation. In recent years, molecules with antifibrogenic capacity have been developed and have demonstrated their ability to decrease pulmonary fibrogenic activity in diseases such as Idiopathic Pulmonary Fibrosis (IPF). This has been a milestone in the treatment of this disease and, therefore, its possible application to other diseases that share fibrogenic mechanisms with IPF, as PMF. The two molecules with the most clinical experience and approved for IPF are nintedanib and pirfenidone. The antifibrotic properties of pirfenidone have raised great expectations and many clinical trials are currently being carried out in other lung diseases that cause fibrosis, that is why we decide to study the efficacy of pirfenidone in reducing metabolic, inflammatory, and fibrogenic lung disease in patients with artificial stone silicosis and progressive massive fibrosis (PMF).

NCT ID: NCT04161014 Recruiting - Silicosis Clinical Trials

The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial

NiPPs
Start date: October 9, 2020
Phase: Phase 2
Study type: Interventional

Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis. Subjects will be treated with Nintedanib 150mg twice daily for 3 years.

NCT ID: NCT03900858 Recruiting - Clinical trials for Silicosis Tuberculosis

Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)

TB
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000. Silicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.