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Tuberculosis clinical trials

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NCT ID: NCT06022146 Recruiting - Tuberculosis Clinical Trials

TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts

TB-YOUTH
Start date: September 1, 2023
Phase: Phase 3
Study type: Interventional

This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR.

NCT ID: NCT05989802 Recruiting - Tuberculosis Clinical Trials

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

Start date: January 26, 2024
Phase: N/A
Study type: Interventional

Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years. The Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and the Assessing Diagnostics at Point-of-care for Tuberculosis in children (ADAPT for Kids) studies seek to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests for use in children.

NCT ID: NCT05971602 Recruiting - Clinical trials for Pulmonary Tuberculosis

Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

Start date: July 26, 2023
Phase: Phase 2
Study type: Interventional

This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).

NCT ID: NCT05964842 Recruiting - Tuberculosis Clinical Trials

Using SMS Reminders, Phone Calls and Money Incentives to Enhance Linkage to Care of Presumptive TB Patients in Uganda

MILEAGE4TB
Start date: August 14, 2023
Phase: N/A
Study type: Interventional

The major challenge in meeting the WHO's End TB Strategy- reducing tuberculosis (TB) deaths by 90% and incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the continuum of TB care. A systematic review found high levels of pre-treatment LTFU-ranging from 4 to 38%, and was higher in sub-Saharan Africa (18%) compared to Asia (13%). Consequences of pre-diagnosis and pre-treatment LTFU are; untreated TB patients are infectious and can transmit TB to others and not starting TB treatment at all, causes high morbidity and mortality. Therefore, monitoring outcomes of presumptive TB patients is equally important as monitoring treatment outcomes. Short message service (SMS), phone calls and mobile money (MM) incentives have shown promise by improving health outcomes such as uptake of immunization, adherence to TB treatment and antiretroviral therapy (ART). However, there is limited knowledge their effect in increasing linkage to care and treatment for presumptive TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore to leverage SMS reminders, phone call and MM incentives in improving linkage to care of presumptive TB patients. This will be a five arm multi-center individual randomized controlled trial implemented in selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The study population will be presumptive TB patients aged 18 years and above identified within the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis will refer to submitting a sample and obtaining results from the test. Our hypothesis is that using SMS reminders, phone call and Mobile Money incentives will result in increase in the proportion of presumptive TB patients that complete diagnosis and pre-treatment TB cases that initiate treatment.

NCT ID: NCT05947890 Recruiting - Tuberculosis Clinical Trials

Evaluating the Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living With and Without HIV in South Africa

HVTN605A5421
Start date: January 30, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa

NCT ID: NCT05941052 Recruiting - Tuberculosis Clinical Trials

Assessing Diagnostics At Point-of-care for Tuberculosis

ADAPT
Start date: August 28, 2023
Phase: N/A
Study type: Interventional

Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests.

NCT ID: NCT05935696 Recruiting - Pleural Effusion Clinical Trials

A Prospective Observational Study on the Role of Transthoracic Ultrasound in Differentiating Tuberculous From Malignant Pleural Effusion

TUS-TBE
Start date: April 1, 2023
Phase:
Study type: Observational

Primary Endpoint - To assess the prevalence and diagnostic performance of pre-determined echographic features in predicting the diagnosis of TBE from MPE. - To determine the clinical, pleural fluid and echographic parameters that were different among TBE and MPE and to establish a clinical prediction model for TBE. Secondary Endpoint - To assess the correlation between pleural fluid parameters with ultrasound and medical thoracoscopic finding. - To assess the optimal Pf ADA cut-off value to differentiate TBE from MPE in our region.

NCT ID: NCT05926466 Recruiting - Clinical trials for Tuberculosis, Pulmonary

BTZ-043 Dose Evaluation in Combination and Selection

DECISION
Start date: September 21, 2023
Phase: Phase 2
Study type: Interventional

This is a phase 2B, open label study, that will compare the safety and efficacy of three experimental regimens consisting of bedaquiline and delamanid in combination with different doses of BTZ-043, a novel antibiotic, in adult participants with newly diagnosed, drug-sensitive pulmonary tuberculosis. Participants will be assigned to receive either one of the three BTZ-043-containing regimens or a comparator regimen consisting of bedaquiline, delamanid and moxifloxacin. The objective is to find the optimal dose of BTZ-043 with the highest efficacy and safety to be used in subsequent studies.

NCT ID: NCT05916638 Recruiting - Tuberculosis Clinical Trials

MoMa Signature During Granulomatosis

MOSAR
Start date: January 15, 2024
Phase:
Study type: Observational

Sarcoidosis is a systemic inflammatory disease characterized by unspecific granuloma formation. Our hypothesis is that granuloma formation and maintenance mainly relies on the overactivation of monocytes (Mo) and macrophages (Ma). To this end, the study aims (i) to define MoMa systemic signature in sarcoidosis, (ii) to characterize this signature in situ on tissue samples, and (iii) to identify causative factors that participate to the MoMa chronic overactivation. Thus, a cohort of sarcoidosis patients will be compared with tuberculosis patients. The MoMa systemic signature will be defined on whole blood (TruCulture model) and then in situ through different methods (multi-parameter spectral flow cytometry, RNA-seq, Luminex, imaging mass cytometry). The epigenome of monocytes will be studied thanks to CUT&Tag. The MoMa systemic signature will be defined ex vivo at different time points during the course of the disease with phenotypic, transcriptomic, cytokine and functional approaches. The previously identified signature will be studied in situ and completed by the characterization of granuloma architecture and microenvironmental interactions, which could be modulated by epigenetic modifications. Hence, the epigenome of monocytes will be analyzed in two groups (sarcoidosis and tuberculosis). These results would allow to better understand sarcoidosis physiopathology and, in fine, may raise new therapeutic strategies. Finally, the study could challenge the dogma on innate immunity/auto-inflammation versus adaptive immunity/auto-immunity/memory.

NCT ID: NCT05899179 Recruiting - Clinical trials for Latent Tuberculosis Infection

Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above

Start date: August 3, 2023
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other lung diseases who met the inclusion criteria of this study. Blood supply specific gamma-interferon (T-SPOT) detection was performed first. Then, EC and Purified Protein derivation of tuberculin (TB-PPD) skin tests were performed on both arms, and the recorded results were observed. The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.