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A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment

Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…

Validation of Interferon Gamma Release Assays (IGRA) using frozen Peripheral Blood Mononuclear Cells (PBMC)

Determining the impact of freezing PBMC on the test result of the IGRA.

The pharmacokinetic effect of clarithromycin on the AUC0-12h of linezolid in
multidrug-resistant and extensively drug-resistant tuberculosis patients

The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…

Enhancement of the sensitivity of a whole-blood interferon gamma assay (Quantiferon TB Gold) for diagnosis of latent tuberculosis infection

Enhancement of the sensitivity of the Quantiferon test for patients with an inflammatory disease who are screened for presence of latent tuberculosis infection.

Breath, sputum, serum and urine analysis for the diagnosis of tuberculosis; characterisation of volatile biomarkers for TB

The aim of our study is the development of a simple device that is able to differentiate between sputum from TB patients and non TB patients.With the knowledge and concentration of the VOCs from M. tuberculosis and possible the specific host…

Differential modulation of dendritic cell (DC) maturation and associated signal transduction as the pivotal events for leprosy spectral pathology

Overall aim: To study the influence of M.leprae antigens on differentiation and maturation of DCs and to identify M.leprae antigens, receptors on antigen presenting cells and signaling pathways which play a role in leprosy pathology. Main objective…

Pharmacokinetic evaluation and local tolerability of dry powder amikacin via the Cyclops® in patients with drug susceptible tuberculosis

The first main objective is to investigate the pharmacokinetic properties of dry powder amikacin at different dosages and compare the peak serum values to a single i.v. dose. The secondary main objective is to assess the local tolerability of dry…

Safety of Rifampicin at High Dose for the Treatment of Adult Subjects with Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis

Primary Objective: To evaluate the safety of high-dose rifampicin (35 mg/kg/d) supplemented with standard doses of isoniazid, pyrazinamide, and ethambutol for 8 weeks in adult subjects with pulmonary or extrapulmonary DS-TB belonging to difficult to…

Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patients

This study has been transitioned to CTIS with ID 2023-509885-39-00 check the CTIS register for the current data. The primary objective is to describe and compare the incidence of hepatotoxicity in standard care and in a regimen with an optimized…

A randomized controlled trial on hypertonic saline inhalation in patients with nodular-bronchiectatic Mycobacterium avium complex pulmonary disease

To determine the effect of hypertonic saline inhalation and best supportive care versus best supportive care alone on clinical efficacy measures in patients with nodular-bronchiectatic M. avium complex pulmonary disease, as measured by changes in…