Showing 76–100 of 129 documents
Sorted by hybrid relevance (keyword + semantic via RRF)
C. Robert Horsburgh, MD
The proposed study will randomize adults (18 years of age or older) with pulmonary MDR-TB with sputum that contains M. tuberculosis that is isoniazid and rifampin resistant by MTBDRplus and fluoroquinolone susceptible by MTBDRsl HIV seropositive (with or without antiretroviral th…
Gustavo E Velásquez, MD, MPH
PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2/3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resist…
Max O'Donnell, MD, MPH
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (…
Heping Xiao, M.D
Multi-center, prospective study is performed to investigate the efficacy of new short-course regimen for retreatment pulmonary tuberculosis patients. To obtain optimized short-course regimen, decrease treatment cost and improve success rate. China is the country with the second…
Otsuka Pharmaceutical Development & Commercialization, Inc.
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible. The trial was performed globally at 14 sites qualified to treat MDR-TB. All 434 pa…
Gates MRI
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 partic…
JW C Alffenaar, PhD PharmD
This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB). Patients receive MDR-TB treatment with o.a. Levofloxacin and Capreomycin. At least one week after start of treatme…
Janssen Research & Development, LLC Clinical Trial
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less than \[\<\] 18 years of age) diagnosed with confirm…
Jae-Joon Yim, MD
The current standard short-course treatment for pulmonary TB requires 6 months to complete. This long duration of treatment increases the likelihood of side effects while decreasing patients' adherence to anti-TB drugs. Linezolid showed considerable efficacy against refractory mu…
Global Clinical Development
The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment. The primary objective of this trial is to evaluate the efficacy of de…
Rodney Dawson
The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment. The trial design is a phase 2, multi-center, open-label, partially randomized clin…
Simbarashe G Takuva, MD, MSc.
This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drug…
University of Oxford
This is a prospective descriptive and pharmacokinetic study will be conducted among newly diagnosed patients registered in the two SMRU TB clinics located on the Thai-Myanmar border. This study aims to recruit (1) 30 adults with HIV co-infection and (2) 30 adults without HIV co-i…
Melchor VG Frias, IV, MD, Anjanette Reyes-De Leon, MD, Louvina van der Laan, MD
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in pediatric participants who completed Study 242-12-232 (NC…
Jussi Saukkonen, MD, Waffa El-Sadr, MD, Nesri Padayachin, MBChB
The antibiotic linezolid when given for the treatment of multi-drug resistant tuberculosis is safe and tolerated at a low dose (600 mg daily) for a limited duration (16 weeks)
University Medical Center Groningen
Rationale: Treatment in tuberculosis (TB) is focused on eradication of the bacterial infection, however, after treatment approximately half of patients are left with a significant and permanent respiratory impairment. Adjunctive host-directed therapies are being investigated to …
liu yidian
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course regimens (BDLLfxC or BDCZ) in patients with multidrug…
Subodh Katiyar, MD, Shivesh Prakash, MBBS, Shailesh Bihari, MD, Hemant Kulkarni, MD, Manju Mamtani, MD
The need for a standardized treatment protocol for multidrug resistant tuberculosis (MDR-TB) in resource-limited countries is being increasingly recognized. This single center, double blind, randomized controlled trial was designed to compare the time required for sputum culture …
Kerkhoff AD, Havlir DV
Due to COVID-19, this year marked the first virtual Conference on Retroviruses and Opportunistic Infections (CROI) in the conference's 27-year history. There were important studies presented that provided new insights into the prevention, diagnosis, and treatment of tuberculosis …
Guglielmetti L, Chiesi S, Eimer J, Dominguez J, Masini T, et al.
Drug-resistant tuberculosis (TB) represents a substantial threat to the global efforts to control this disease. After decades of stagnation, the treatment of drug-resistant TB is undergoing major changes: two drugs with a new mechanism of action, bedaquiline and delamanid, have b…
Ravindra Kumar Garg
**INTRODUCTION:** Tuberculous meningitis is frequently associated with significant mortality and persistent neurological sequelae. Diagnosis is often delayed due to nonspecific symptoms and the low sensitivity of cerebrospinal fluid (CSF) tests. Standard pulmonary tuberculosis re…
Marina Atarshchikova
Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB. Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.
Cristina Vilaplana, MD, PhD
The purpose of this study is to assess the efficacy and safety of 2 repurposed drugs (acetylsalicylic acid and ibuprofen), for use as adjunct therapy added to, and compared with, the standard of care (SoC) WHO-recommended TB regimen in drug-sensitive (DS) and multi-drug resistant…
Baluku JB, Bongomin F
Background There is a dearth of reports on drug-resistant tuberculosis (DRTB) treatment outcomes among pregnant women in tuberculosis (TB)/HIV high-burdened countries. We report treatment outcomes of 18 pregnant women with DRTB in Uganda. Methods We reviewed charts of individuals…
National Institute of Allergy and Infectious Diseases (NIAID)
The purposes of this study are to determine: how safe it is to take SQ109 (an experimental tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how well the body accepts it; how SQ109 enters and leaves the body and blood tissues over time; the amo…