@article{fdi:010063069,
  title = {{A} four-month gatifloxacin-containing regimen for treating tuberculosis},
  author = {{M}erle, {C}.{S}. and {F}ielding, {K}. and {B}ah {S}ow, {O}. and {G}nignafon, {M}. and {L}o, {M}.{B}. and {M}thiyane, {T}. and {O}dhiambo, {J}. and {A}mukoye, {E}. and {B}ah, {B}. and {K}assa, {F}. and {N}'{D}iaye, {A}. and {R}ustomjee, {R}. and {D}e {J}ong, {B}.{C}. and {H}orton, {J}. and {P}erronne, {C}. and {S}ismanidis, {C}. and {L}apujade, {O}. and {O}lliaro, {P}.{L}. and {L}ienhardt, {C}hristian},
  editor = {},
  language = {{ENG}},
  abstract = {{BACKGROUND} : {S}hortening the course of treatment for tuberculosis would be a major improvement for case management and disease control. {T}his phase 3 trial assessed the efficacy and safety of a 4-month gatifloxacin-containing regimen for treating rifampin-sensitive pulmonary tuberculosis. {METHODS} : {W}e conducted a noninferiority, randomized, open-label, controlled trial involving patients 18 to 65 years of age with smear-positive, rifampin-sensitive, newly diagnosed pulmonary tuberculosis in five sub-{S}aharan {A}frican countries. {A} standard 6-month regimen that included ethambutol during the 2-month intensive phase was compared with a 4-month regimen in which gatifloxacin (400 mg per day) was substituted for ethambutol during the intensive phase and was continued, along with rifampin and isoniazid, during the continuation phase. {T}he primary efficacy end point was an unfavorable outcome (treatment failure, recurrence, or death or study dropout during treatment) measured 24 months after the end of treatment, with a noninferiority margin of 6 percentage points, adjusted for country. {RESULTS} : {A} total of 1836 patients were assigned to the 4-month regimen (experimental group) or the standard regimen (control group). {B}aseline characteristics were well balanced between the groups. {A}t 24 months after the end of treatment, the adjusted difference in the risk of an unfavorable outcome (experimental group [21.0%] minus control group [17.2%]) in the modified intention-to-treat population (1356 patients) was 3.5 percentage points (95% confidence interval, -0.7 to 7.7). {T}here was heterogeneity across countries ({P} = 0.02 for interaction, with differences in the rate of an unfavorable outcome ranging from -5.4 percentage points in {G}uinea to 12.3 percentage points in {S}enegal) and in baseline cavitary status ({P} = 0.04 for interaction) and body-mass index ({P} = 0.10 for interaction). {T}he standard regimen, as compared with the 4-month regimen, was associated with a higher dropout rate during treatment (5.0% vs. 2.7%) and more treatment failures (2.4% vs. 1.7%) but fewer recurrences (7.1% vs. 14.6%). {T}here was no evidence of increased risks of prolongation of the {QT} interval or dysglycemia with the 4-month regimen. {CONCLUSIONS} : {N}oninferiority of the 4-month regimen to the standard regimen with respect to the primary efficacy end point was not shown. ({F}unded by the {S}pecial {P}rogram for {R}esearch and {T}raining in {T}ropical {D}iseases and others; {C}linical{T}rials.gov number, {NCT}00216385.)},
  keywords = {{BACTERIOSE} ; {TRAITEMENT} {MEDICAL} ; {ANTIBIOTIQUE} ; {ESSAI} {CLINIQUE} ; {TUBERCULOSE} {HUMAINE} ; {FLUOROQUINOLONE} ; {GATIFLOXACINE} ; {EFFET} {INDESIRABLE} ; {AFRIQUE} {SUBSAHARIENNE} ; {AFRIQUE} {DU} {SUD} ; {BENIN} ; {GUINEE} ; {KENYA} ; {SENEGAL}},
  booktitle = {},
  journal = {{N}ew {E}ngland {J}ournal of {M}edicine},
  volume = {371},
  numero = {17},
  pages = {1588--1598},
  ISSN = {0028-4793},
  year = {2014},
  DOI = {10.1056/{NEJM}oa1315817},
  URL = {https://www.documentation.ird.fr/hor/fdi:010063069},
}