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An Open-Label Safety Extension Study to a 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 Objective To evaluate long term safety and tolerability of LAI (590 mg) administered once daily (QD) for up to 12 months in subjects who were refractory to standard multi-drug treatment and failed to convert in Study INS-212. Secondary…

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…

PHARMACOKINETICS AND PHARMACODYNAMICS OF ERTAPENEM IN PATIENTS WITH TUBERCULOSIS

The main objective is to evaluate pharmacokinetics of a maximum standard dose (2000mg) of ertapenem in TB patients.

Pharmacokinetic parameters of 960 mg Co-trimoxazole once daily in patients with tuberculosis

Primary Objective: The primary objective of this prospective clinical trial is to determine the pharmacokinetic variability of SXT (960 mg) in patients receiving TB treatment. With these pharmacokinetic parameters, a population model and limited…

Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculosis after successful intensive-phase treatment.

Primary endpoint: Evaluation of the safety of the novel anti-TB vaccine RUTI® (25*g FCMtb) in patients with MDR-TB favourably responding to second-line, standard MDRTB treatment through clinical, microbiological, and radiological response criteria.…

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…

Pharmacokinetic study with a loading dose of clofazimine in adult patients with nontuberculous mycobacterial disease

The overarching aim of this study is to contribute to dose optimization of CFZ in the treatment of NTM diseases.The primary objective of this study is to describe the PK of CFZ, after 4 weeks of treatment with a loading dose regimen of 300 mg once…

A prospective, randomized pilot study of the immunomodulatory effects of azithromycin in adults with pulmonary tuberculosis

1. To assess whether azithromycin enhances resolution of systemic inflammation in patients with drug susceptible pulmonary TB receiving HRZE treatment. 2. To assess whether azithromycin on top of HRZE treatment in patients with drug susceptible…