A Four-Month Gatifloxacin-Containing Regimen for Treating Tuberculosis

Merle, Corinne; Fielding, Katherine; Sow, Omou Bah; Gninafon, M.; Lo, Mame Bocar; Mthiyane, Thuli; Odhiambo, Joseph; Amukoye, Evans; Bah, Boubacar Billo; Kassa, Ferdinand; Rustomjee, Roxana; Jong, Bouke C. de; Horton, John; Perronne, Christian; Sismanidis, Charalambos; Lapujade, Olivier; Olliaro, Piero; Lienhardt, Christian; Act, Abstr

doi:10.1056/nejmoa1315817

Cited by 355 publications

(363 citation statements)

References 17 publications

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“…In 2014, three trials were reported that relate to treatment shortening based on the substitution of a fluoroquinolone [9][10][11].…”

Section: Early-phase Clinical Studies Of Moxifloxacinmentioning

confidence: 99%

“…[10] and OFLOTUB [11]. Note that moxifloxacin/rifapentine 900 mg was administered twice weekly and moxifloxacin/rifapentine 1200 mg was administered weekly.…”

Section: Remoxtbmentioning

confidence: 99%

“…The end-point (treatment failure, recurrence or death, or study dropout during treatment) was measured 24 months after the end of treatment as defined by culture on LJ medium. A noninferiority design was adopted with a 6% margin, adjusted for country [11].…”

Section: Oflotubmentioning

confidence: 99%

“…The important approach to TB drug development that can yield results rapidly is to repurpose drugs that also have activity against TB. Moxifloxacin is an example of this process and will be the focus of this review, which is timely as the results of three phase III clinical trials utilising a fluoroquinolone as a key component in the treatment of susceptible infection have been reported recently [9][10][11] and novel moxifloxacin regimens for the treatment of MDR disease are in progress [12]. Moxifloxacin also has an important role in the management of patients who are unable to tolerate a …”

Section: Introductionmentioning

confidence: 99%

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The role of moxifloxacin in tuberculosis therapy

Gillespie

2016

Eur Respir Rev

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Tuberculosis (TB) remains a global threat with more than 9 million new infections. Treatment remains difficult and there has been no change in the duration of the standard regimen since the early 1980s. Moreover, many patients are unable to tolerate this treatment and discontinue therapy, increasing the risk of resistance. There is a growing tide of multidrug resistance and few effective antibiotics to tackle the problem. Since the turn of the millennium there has been a surge in interest in developing new therapies for TB and a number of new drugs have been developed. In this review the repurposing of moxifloxacin, an 8-methoxy-fluoroquinolone, for TB treatment is discussed. The evidence that underpins the development of this agent is reviewed. The results of the recently completed phase III trials are summarised and the reasons for the unexpected outcome are explored. Finally, the design of new trials that incorporate moxifloxacin, and that address both susceptible disease and multidrug resistance, is described. @ERSpublications A review of the role of moxifloxacin in tuberculosis therapy http://ow.ly/WaAyC

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“…In 2014, three trials were reported that relate to treatment shortening based on the substitution of a fluoroquinolone [9][10][11].…”

Section: Early-phase Clinical Studies Of Moxifloxacinmentioning

confidence: 99%

“…[10] and OFLOTUB [11]. Note that moxifloxacin/rifapentine 900 mg was administered twice weekly and moxifloxacin/rifapentine 1200 mg was administered weekly.…”

Section: Remoxtbmentioning

confidence: 99%

Section: Oflotubmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The role of moxifloxacin in tuberculosis therapy

Gillespie

2016

Eur Respir Rev

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“…The disappointing results from all recent Phase III trials of TB drugs [2][3][4][5] clearly demonstrate that a shift in paradigm is needed in TB drug development. Insufficient efficacy is the main cause for failures in clinical drug development [6,7].…”

Section: Shift In the Tb Drug Development Paradigm: Reality Or Fiction?mentioning

confidence: 99%

The implications of model-informed drug discovery and development for tuberculosis

Muliaditan¹,

Davies

Simonsson

et al. 2017

Drug Discovery Today

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Antitubercular Agents

Aldrich¹,

Wallis²,

Hegde³

et al. 2021

Burger's Medicinal Chemistry and Drug Discovery

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Mycobacterium tuberculosis remains the leading cause of death due to infection in humans. Although antibiotics are available to treat drug‐sensitive M. tuberculosis infections, the increasing incidence of drug‐resistant strains is threatening our ability to gain hold of this pandemic. In addition, recent research has highlighted that even the current standard of care antibiotics face multiple obstacles for reaching therapeutic concentrations at the site of infection. In this article, we detail the current standard of care for clinical tuberculosis (TB) disease, the chemistry, mechanisms of action, and mechanisms of resistance for the antibiotics used clinically to treat TB, the growing problem of antibiotic resistance, and other challenges associated with TB treatment, and host‐directed therapies as an additional approach to treatment. This article is meant to serve as the foundation to build from as the field addresses the dire need for continued development of new therapeutic strategies to treat TB.

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A Four-Month Gatifloxacin-Containing Regimen for Treating Tuberculosis

Abstract: Noninferiority of the 4-month regimen to the standard regimen with respect to the primary efficacy end point was not shown. (Funded by the Special Program for Research and Training in Tropical Diseases and others; ClinicalTrials.gov number, NCT00216385.).

Cited by 355 publications

References 17 publications

The role of moxifloxacin in tuberculosis therapy

The role of moxifloxacin in tuberculosis therapy

The implications of model-informed drug discovery and development for tuberculosis

Antitubercular Agents

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