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Tuberculosis clinical trials

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NCT ID: NCT05047315 Recruiting - Tuberculosis Clinical Trials

Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV

Stool4TB
Start date: December 1, 2021
Phase:
Study type: Observational

Stool4TB aims to evaluate an innovative stool-based qPCR diagnostic platform (with the capacity to become a POC diagnostic tool) in the high TB and HIV burden settings of Mozambique, Eswatini and Uganda, under the hypothesis that it will narrow the extremely large TB case detection gap by improving TB confirmation rates in children and people living with HIV (PLHIV).

NCT ID: NCT05047055 Active, not recruiting - Clinical trials for Tuberculosis, Pulmonary

Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients

Start date: March 15, 2022
Phase:
Study type: Observational

The 4-month daily regimen containing moxifloxacin (2HRZEM 7 / 2HRM7) of ICMR-NIRT was studied in 321 sputum positive pulmonary TB patients in a randomised clinical trial. Of the 321, there were 96% with sputum smear grading of 2+/3+ and 80% with >2 zone involvement in the chest radiograph, The sputum culture conversion at the end of intensive phase was 94%, favourable response at the end of treatment of 92% and the TB recurrence rate was 4.1%. The regimen was safe and well tolerated. The advantages of a 33% reduction in treatment duration are manifold in terms of financial and other administrative implications. As the next logical step investigators believe that the effectiveness of this shortened regimen that proved successful in our study needs to be tested in the field. Under NTEP the anti-TB drugs are offered as Fixed dose Combination (FDC).3 The HREZ intensive phase and HRE continuation phase FDC are administered to patients based on body weight category. If our proposed study proves successful, the addition of moxifloxacin tablet to the FDC of anti-TB drugs in the intensive and continuation phases of treatment would be feasible under TB program settings. Investigators propose to evaluate 4-month moxifloxacin containing daily regimen [2 months of HRZEM daily / 2 months of HREM daily (2 HRZEM 7 / 2HREM7)] in the treatment of newly diagnosed sputum smear positive pulmonary TB patients.

NCT ID: NCT05046366 Recruiting - Lung Cancer Clinical Trials

Development of an Artificial Intelligence System for Intelligent Pathological Diagnosis and Therapeutic Effect Prediction Based on Multimodal Data Fusion of Common Tumors and Major Infectious Diseases in the Respiratory System Using Deep Learning Technology.

Start date: October 1, 2021
Phase:
Study type: Observational

To improve accurate diagnosis and treatment of common malignant tumors and major infectious diseases in the respiratory system, we aim to establish a large medical database that includes standardized and structured clinical diagnosis and treatment information such as electronic medical records, image features, pathological features, and multi-omics information, and to develop a multi-modal data fusion-based technology system for individualized intelligent pathological diagnosis and therapeutic effect prediction using artificial intelligence technology.

NCT ID: NCT05045391 Active, not recruiting - Aspergillosis Clinical Trials

Pulmonary Aspergillosis in Tuberculosis Patients

Start date: January 1, 2020
Phase:
Study type: Observational

Pulmonary tuberculosis (PTB) is the most common cause of lung destruction, contributing to coinfections development, and Aspergillosis spp. is one of the most important. Diagnosis of chronic pulmonary aspergillosis (CPA) in PTB patients is difficult due to similarity of clinical and radiological data, especially in resource-constrained settings. Differentiation of PTB patients with singling out a group with a higher Aspergillus IgG level during the initial examination will help physicians to orient to further examination of CPA. Objectives: to determine the prevalence of aspergillosis in Koch's bacillus-positive and Koch's bacillus-negative PTB patients and antifungal resistance of Aspergillus species isolates in Central Asia countries.

NCT ID: NCT05044910 Active, not recruiting - Tuberculosis Clinical Trials

The Impact of Malnutrition on Immune Responses to Tuberculosis

TBMAM
Start date: August 1, 2020
Phase:
Study type: Observational

The aim of this study is to assess immune responses to Mtb in children with MAM compared to well-nourished children and to evaluate the impact of a nutrition intervention on these immune responses.

NCT ID: NCT05042063 Recruiting - Asthma Clinical Trials

Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease

Start date: September 15, 2021
Phase:
Study type: Observational

This study pretends to evaluate the potential use of Hyfe Cough Tracker (Hyfe) to screen for, diagnose, and support the clinical management of patients with respiratory diseases, while enriching a dataset of disease-specific annotated coughs, for further refinement of similar systems.

NCT ID: NCT05036694 Not yet recruiting - Clinical trials for HIV Primary Infection

Diagnostic Performance of a Novel Lipoarabinomannan.

FUJILAM
Start date: September 2021
Phase: N/A
Study type: Interventional

The Fujifilm SILVAMP TB LAM (FujiLAM; Fujifilm, Tokyo, Japan) is a novel (not commercialized) urine based point-of-care assay to diagnose TB in HIV-positive patients. A first study using urine frozen samples has reported a higher sensitivity of this test over the currently commercialised Alere Determine TB LAM Ag assay (AlereLAM).

NCT ID: NCT05027958 Recruiting - Healthy Clinical Trials

Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung

Start date: May 3, 2022
Phase: Early Phase 1
Study type: Interventional

Background: Tuberculosis (TB) is a lung disease. It is caused by inhaling a type of airborne bacterium. Tuberculin Purified Protein Derivative (PPD) is used to test for TB exposure. It is usually injected under a person s skin. In this study, it will be applied in the lung. Objective: To learn how the cells within the lung react (immune response) when exposed to PPD. Eligibility: Adults ages 18-64 who (1) have been exposed to TB but do not have active disease or symptoms or (2) have never been exposed to TB. Design: Participants will be screened with a medical history, physical exam, and blood tests. They will have a TB skin test. They will also have an electrocardiogram to examine heart rhythm. For this, sticky patches will be placed on their chest. Some screening tests will be repeated at study visits. Participants will have 3 FDG PET-CT scans. They will lie in a machine that creates pictures of the inside of their body. They will get a radioactive substance injected into their arm called 18FDG. It helps make the pictures. Participants will have 3 bronchoscopies. Their mouth and nasal airways will be numbed. They will get drugs to relax. A tube will be inserted through their nose or mouth into a lung. Fluid will be delivered into the lung and suctioned back out to collect cells. They will get PPD during the first bronchoscopy. Participation will last for about 30 days. Participants will visit the clinic up to 8 times. They will go home after each procedure. No hospital stays are needed.

NCT ID: NCT05022862 Recruiting - Latent Tuberculosis Clinical Trials

Economic Incentives and vDOT for Latent Tuberculosis Infection

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a novel and scalable intervention that combines Video Directly Observed Therapy (vDOT) and financial incentives to promote completion of treatment for latent tuberculosis. Adult participants who are initiating treatment for latent tuberculosis will be recruited from the Baltimore City Health Department. The primary hypothesis is that the incentive intervention will increase the percentage of participants that complete the treatment for latent tuberculosis above the completion rates of participants receiving usual care.

NCT ID: NCT05022238 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Hotspots, Households and Hospitals: Enhanced Drug-resistant Tuberculosis Case Finding in Namibia

H3TB
Start date: August 1, 2022
Phase:
Study type: Observational

Poor case management, pharmacokinetic variability and on-going transmission have fostered the drug-resistant tuberculosis (DR-TB) epidemic leading to a global estimated number of >500,000 new multidrug resistant (MDR) TB cases per year, of which roughly 10% are extensively drug resistant (XDR). Namibia is a high TB burden country with an incidence rate of 446/100,000 in 2016; about 11,000 new cases per year. 3.9% of new cases and 8.7% of previously treated cases have MDR-TB. Whole genome sequencing (WGS) has recently been applied to interrogate the complete genetic code of Mycobacterium tuberculosis (Mtb) strains. WGS can be used to infer relationships between identified strains as well as determine genomic variations involved in resistance development. The specific aims of the H3TB study are to: (i) characterise the DR-TB epidemic, in terms of clinical, epidemiological, geospatial, social network and laboratory data, to identify transmission hotspots in three regions of Namibia, (ii) evaluate the feasibility of targeted case finding intervention strategies to improve DR-TB control in highly affected populations and (iii) develop a transmission model to investigate the potential impact of the case finding intervention strategies on DR-TB incidence in Namibia. A prospective surveillance study started in January 2020, which includes all DR-TB cases in Namibia, and which will nest H3TB. Data collection tools and other study implementation tools have been designed and implemented. The study team is working in close collaboration with the National Institute of Pathology, where all DR-TB cases from the country are registered, to ensure all possible cases are captured. This is important for the identification of transmission hotspots. After HREC and MOHSS approval, individuals with GeneXpert® MTB/RIF rifampicin-resistant samples and a positive Mtb culture from three regions in Namibia will be included in a transmission hotspot identification study. Preliminary data have shown that DR-TB clusters exist in these regions. Clinical, epidemiological, geospatial, social network and laboratory data (GeneXpert® MTB/RIF, culture, drug sensitivity tests) will be collected. WGS capacity has been established at the UNAM research laboratory, where WGS will be performed on the samples of H3TB participants; results will be validated at the Research Center Borstel in Germany. These study results in conjunction with a systematic review and meta-analysis will inform the design of case finding interventions which will be evaluated through a mixed-methods feasibility study conducted at high transmission areas (hotspots, households and hospitals). Data from these studies and the TB programme will be used to develop the model which will include a health economics component. The study will strengthen DR-TB diagnosis, surveillance and control, inform DR-TB case finding policy in Namibia and regionally, inform resource allocation by identifying high transmission areas and create preliminary data to design a large scale DR-TB case finding intervention.