Showing 101–125 of 200 documents
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Gifty Okyere-Manu, MBChB
…. Study Drug Rationale Given the increasing need for novel regimens and highly eqective, well-tolerated drugs to treat participants with TB, it is important to evaluate the antituberculosis activity of established anti- TB drugs that have been enhanced to generate higher eqicacy…
Freundeskreis Für Internationale Tuberkulosehilfe e.V
… to active disease. The long treatment of TB infection with regimens lasting from three to nine months is a significant barrier to treatment completion in individuals with a confirmed diagnosis of TB infection. Adapting a shorter regimen than the current regimens could lead to a …
Rada Savic, PhD
…with or without moxifloxacin as part of multidrug treatment regimens for drug-sensitive pulmonary TB. The proposed study (Study 31 PK/PD) will examine the population pharmacokinetics and pharmacodynamics (PK/PD) of high-dose daily rifapentine with and without moxifloxacin given f…
Susan Dorman, MD, Neil Schluger, MD, Jason Stout, MD
…y, and estimate the antimicrobial activity, of experimental regimens that include isoniazid + pyrazinamide + ethambutol plus either rifapentine 15 mg/kg/dose or rifapentine 20 mg/kg/dose, all administered daily. Assessment of these doses of rifapentine will be performed as an ext…
Charles Horsburgh, MD, Payam Nahid, MD
…rculosis (XDR-TB).(1) Current WHO-endorsed MDR-TB treatment regimens take 9-20 months to complete and are associated with substantial toxicity, including deafness from injectable agents, hepatitis from pyrazinamide and severe neuropathy from linezolid. Given the long duration and…
Jann-Yuan Wang, MD. PhD.
…lease assay (IGRA). For preventive therapy, the recommended regimens include daily isoniazid for 9 months and daily rifampicin for 4 months. By incorporating long-acting rifapentine, a new regimen combining weekly rifapentine and high-dose isoniazid for a total of 12 doses has be…
Keertan Dheda, MD/PhD
…-infected participants already on alternative ARV treatment regimens will be changed to the above-mentioned regimen. (v) Participants whose MDR-TB treatment has failed: In the conventional arm, management of failed MDR-TB treatment will be as per the NTP guidelines (with guidanc…
Francesca M Conradie
…ones were moved to Category A and should be included in all regimens as core drugs. CFZ and terizidone as Category B drugs, should be added to all regimens. The current short injectable-free treatment regimen for RR-TB in South Africa is based on these WHO recommendations. This …
Surendra K Sharma, MD. Ph.D
…d from which the patients suffer and not primarily the drug regimens with which they are treated. However, several of the reports from Africa suggested increased early mortality in those who received the less-potent traditional isoniazid, thiacetazone, and streptomycin regimens t…
Valeria C Rolla, PhD, Valeria C Rolla, PhD
…) in association with rifampin-containing anti-tuberculosis regimens, in patients presenting tuberculosis and HIV-infected with indication to antiretroviral treatment according to Brazilian Ministry of Health's guidelines, with contraindication to the use of NNTRI. * Describe the…
Michael Hoelscher, MD, Martin Boeree, MD
…pare the efficacy and safety of four experimental four drug regimens with a standard control regimen in patients with smear positive, pulmonary tuberculosis (TB). Patients will be randomly allocated to the control or one of the four experimental regimens in the ratio 2:1:1:1:1. E…
Amina Jindani, MD
…standard 6-month control regimen with two 4-month treatment regimens for the treatment of tuberculosis (TB). Disease/patients studied The trial will include 654 patients newly diagnosed with pulmonary TB with sputum positive or negative for TB on microscopy but with a positive r…
Susan Dorman, MD
…e with lengthy (usually 6 months) and complicated treatment regimens. Incomplete TB treatment can lead to serious consequences such as increased severity of illness and death, prolonged infectiousness and transmission in the community, and the development of drug resistance. The …
Tammy Meyers, MD, Paul Krogstad, MD
…ommonly used to treat TB. There is a need for HIV treatment regimens that contain newer ARV medications that are well-tolerated and have minimal interactions with rifampicin-containing TB medication regimens. This study enrolled HIV-infected infants and children: who had never ta…
Centers for Disease Control and Prevention
…d bacteriologic relapse rates associated with the two study regimens. Secondary Objectives: To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy. To compare the clinical and bacteriologic response rates …
Dick Menzies
Rationale: Shorter regimens of high dose daily rifampin may be safe, and as effective as the standard rifampin regimen when taken for 4 months to treat latent TB (LTBI). However, there is insufficient evidence on the optimal dose of rifampin that has similar efficacy as the stan…
Richard E Chaisson, MD, Susan E Dorman, MD, John L Johnson, MD
…upport Phase 3 clinical trials of moxifloxacin in treatment regimens of less than the current 6 month standard regimens. Rationale - Current treatment of smear positive pulmonary tuberculosis requires a minimum of 6 months, a treatment duration that is challenging for patients a…
University of Cape Town
…rse drug effects are common in patients on MDR-TB treatment regimens. Although several common toxicities are linked to specific drugs and are thought to be dose-related, the relationship between PK and toxicity has not been adequately studied. Overlapping toxicity of antiretrovir…
Michael Hoelscher, Prof Dr.
…tudy that will compare the efficacy, safety of experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-contain…
Nesri Padayatchi, MBChB, PhD
…enges, such as culture contamination. Furthermore, initial regimens are often not optimal and sometimes completely ineffective as there is a lack of Drug Susceptibility Testing to support them. More importantly, even optimal regimens are changed due to patient intolerance of the…
Kamila Romanowski, Yen Pham Ngoc, Leila Barss, Elias Jabbour, James C Johnston, et al.
…eration when implementing tuberculosis preventive treatment regimens (TPT). We used data from a phase 2b randomized trial of TPT to estimate overall cost and key drivers of costs for two TPT regimens. **METHODS:** We did a post-hoc analysis of 915 participants aged ≥10 ye…
Ekaterina V Kurbatova, William C Whitworth, Kia E Bryant, Meredith G Dixon, Kelly E Dooley, et al.
A previous study demonstrated noninferior efficacy of 4-month rifapentine/moxifloxacin regimen for tuberculosis (TB) treatment compared with the standard regimen. We analyzed pregnancy outcomes of women who became pregnant during the study. Among 740 women, 97 (13.1%) became…
Olanisun O Adewole, MD, Olanisun O Adewole, MD, Bolanle A Omotoso, MD
Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally. According to recent estimates from the World Health Organization (WHO), over 10 million new cases and 1.6 million deaths from TB occurred in 2021. The vast majorit…
Li Ding, M.D, Yuanli Chen, M.Med, Xi Liu, M.D, JinYu Xia, M.Med, Zhongsi Hong, M.Med, et al.
This study aims to find an optimized initial regimen for pulmonary tuberculosis(PTB), evaluating the efficacy, safety and acceptability of isoniazid, rifampicin and moxifloxacin(HRM) for the intensive phase of initial therapy of PTB, compared with the standard initial regimen. T…
Lorenzo Guglielmetti, MD, Carole Mitnick, Sc.D
…ng the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB). This is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of new combination regimens for MD…