A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: Design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

Trials

Volumn 13, Issue , 2012, Pages

  Merle, Corinne S C ^a   Sismanidis, Charalambos ^a   Sow, Oumou B ^b   Gninafon, Martin ^c   Horton, John ^d   Lapujade, Olivier ^e   Lo, Mame B ^f   Mitchinson, Denis A ^g   Perronne, Christian ^h   Portaels, Francoise ⁱ   Odhiambo, Joseph ^j   Olliaro, Piero ^e   Rustomjee, Roxana ^k   Lienhardt, Christian ^l   Fielding, Katherine ^a  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^b Hopital Ignace Deen   (Guinea)

^c Centre National Hospitalier de Pneumo Phtisiologie   (Benin)

^d Tropical Projects   (United Kingdom)

^e WORLD HEALTH ORGANIZATION   (Switzerland)

^f Programme National de Lutte contre la Tuberculose   (Senegal)

^g ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^h LABORATOIRE DES SCIENCES DU CLIMAT ET DE L ENVIRONNEMENT   (France)

ⁱ Tropical Institute of Medicine of Antwerp   (Belgium)

^j KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^k SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^l Stop TB Partnership   (Switzerland)

more..

Author keywords

Design issues; Gatifloxacin; Multicenter; Non inferiority design; Phase III; Randomized controlled trial; Tuberculosis treatment

Indexed keywords

ETHAMBUTOL; GATIFLOXACIN; ISONIAZID; PYRAZINAMIDE; RIFAMPICIN;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; TREATMENT DURATION; TREATMENT OUTCOME;

AFRICA; ANTITUBERCULAR AGENTS; DIRECTLY OBSERVED THERAPY; DRUG THERAPY, COMBINATION; FLUOROQUINOLONES; HUMANS; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME; TUBERCULOSIS;

EID: 84861123740     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-61     Document Type: Article

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