Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,931

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

October 31, 2013

Study Completion Date

February 28, 2014

Conditions
Pulmonary Tuberculosis
Interventions
DRUG

Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin

"Moxifloxacin 400 mg Rifampicin \< 45 kg 450 mg \> 45 kg 600 mg Isoniazid 300 mg Pyrazinamide \< 40 kg 25 mg/kg rounded to nearest 500 mg\* 40-55 kg 1000 mg \> 55 kg - 75 kg 1500 mg \> 75 kg 2000 mg Ethambutol \< 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg \> 55 kg - 75 kg 1200 mg \> 75 kg 1600 mg \*For pyrazinamide dosing in patients \< 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."

Trial Locations (47)

2092

Clinical HIV Research Unit (CHRU), Johannesburg

7700

Centre for TB Research and Innovation, University of Cape Town Lung Institute, Cape Town

10400

Rajavithi Hospital, Division Of Pulmonary Medicine, Bangkok

11000

Chest Disease Institute (CDI), Ministry of Public,, Nonthaburi

40200

Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University, Khon Kaen

45170

Hospital General de Occidente de la secretaria, Guadalajara

53000

Institute of Respiratory Medicine (IPR) Jalan Pahang, Kuala Lumpur

101149

Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing

110002

Dr. D.K. Chauhan, New Delhi

110026

Centre for advanced lung and sleep disorders, New Delhi

110043

Dr. Mittal's clinic, New Delhi

110062

Diligent Hospital, New Delhi

110087

A-One Hospital, Delhi

200433

Shanghai Pulmonary Hospital, Shanghai

300041

TB Institute, Tianjin

2011002

Dr. R. K. Garg's Clinic,, Ghaziabad

Unknown

Nirmal Kumar Jain, Jaipur

Mahatma Gandhi Medical College& Hospital, Jaipur

Ram-Tej Hospital,, Agra

Siddharth Nursing Home,, Agra

Rajul Nursing Home, Aligarh

Varshneya Chest Clinic & Eye Care Centre, Aligarh

Dr. Neeraj Gupta Clinic, Firozabad

S.P.S Chauhan Clinic, Firozabad

Indra Nursing Home and Maternity Centre, Ghaziabad

Dr. AK Singh Clinic, Kanpur

Dr. S. K. Katiyar, Swaroop Nagar,, Kanpur

Guru Tej Bahadur Hospital, Kanpur

Dr. Komal Gupta, Lucknow

New City Hospital and Trauma Centre,, Lucknow

Surya Chest Foundation,, Lucknow

Surya Kant Clinic, Lucknow

Arya Chest Clinic, UP,India, Meerut

Dr. Mahip Saluja Clinic, U.P., Meerut

Dr. S. P. Sondhi Clinic,, Meerut

Sri Ram Plaza, Meerut

Jigyasa Medical Center, Morādābād

Saanvi MultiSpeciality Clinic,, Morādābād

Ish Medical Centre and Respiratory Lab,, New Delhi

Smt Prakash Devi Memorial Medical Centre,, New Delhi

Centre for Respiratory Disease Research at KEMRI, Nairobi

Tiervlei Trial Center and University of Stellenbosch, Cape Town

Unit for Clinical & Biomedical TB Research, MRC Durban, Durban

NIMR Mbeya Medical Research Programme, Mbeya

Kilimanjaro Christian Medical Centre, Moshi

University Teaching Hospital, Lusaka

0250

Madibeng centre for Research, 40 Pienaar Street,, Madibeng

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

collaborator

University College, London

OTHER

collaborator

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

collaborator

Sanofi

INDUSTRY

lead

Global Alliance for TB Drug Development

OTHER