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

Summary

REMoxTB is a study for the "Rapid Evaluation of Moxifloxacin in the treatment of sputum smear positive tuberculosis". REMoxTB aims to find and evaluate new drugs and regimens that shorten the duration of tuberculosis therapy.

The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two moxifloxacin-containing treatment combinations to determine whether substituting ethambutol with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in another combination, makes it possible to reduce the duration of treatment for TB.

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.

Sponsors & Collaborators

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• University College, London

  collaborator OTHER

• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

  collaborator INDUSTRY

• Sanofi

  collaborator INDUSTRY

• Global Alliance for TB Drug Development

  lead OTHER

Principal Investigators

• Stephen H Gillespie, MB BCh BAO MD DSc · University of St Andrews

• Andrew Nunn, BSc MSc · MRC Clinical Trials Unit

• Sarah K Meredith, MB BS MSc · MRC Clinical Trials Unit

• Timothy D McHugh, BSc PhD CSi · Centre for Medical Microbiology, Royal Free and University College Medical School

• Ali Zumla, BSc MBChB MSc PhD · Centre for International Health, Royal Free and University College Medical School

• Alexander Pym, MB BMRCP PhD · Unit for Clinical & Biomedical TB Research, MRC Durban

• Peter Mwaba, MB ChB MMed PhD · University Teaching Hospital

• Noel Sam, MMed MD · Kilimanjaro Christian Medical Centre

• Andreas Diacon, BM MD · Tiervlei Trial Center and University of Stellenbosch

• Rodney Dawson, MB ChB FCP · Centre for TB Research and Innovation, UCT Lung Institute

• Evans Amukoye, MBChB. Mmed (Paediatric) · Centre for Respiratory Disease Research at KEMRI

• Leonard Maboko, MD MSc PhD · NIMR - Mbeya Medical Research Programme

• Ian Sanne, MBBCH FCP(SA) · Clinical HIV Research Unit (CHRU), Westdene

• Cheryl Louw, MBChB · Madibeng Centre For Research, Brits

• Mengqui Gao, MD · Beijing Tuberculosis and Thoracic Tumor Research Institute

• Qing Zhang, MD · Shanghai Pulmonary Hospital, Shanghai, China

• Xiexiu Wang, MD · TB Institute, Tianjin

• Aziah Mahayiddin, MD · Institute of Respiratory Medicine (IPR) Jalan Pahang, Malaysia

• Watchara Boonsawat, MD PhD · Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University

• Charoen Chuchottaworn, MD · Chest Disease Institute (CDI), Ministry of Public Health, Nonthaburi

• Pairaj Kateruttanakul, MD · Rajavithi Hospital, Division of Pulmonary, Department of Medicine, Bangkok

• Gerardo Amaya-Tapia, MD · Hospital General de occidente de la secretaria, Seattle, Mexico

• Stephen Murray, M.D, PhD · Global Alliance for TB Drug Development

• Michael Brown, BA, BM, BCh, MRCP, PhD, DTM&H · London School of Hygiene and Tropical Medicine

• Rakesh Lal, MD · Centre for Advanced Lung and Sleep Disorders, New Delhi, India

• Rakesh Mittal, MBBS MD · Dr. Mittal's Clinic, Balaji Medical Store, New Delhi, India

• A K Jain, MBBS FICA · Diligent Hospital, New Delhi, India

• Mahesh Kapoor, MBBS DTCD · A One Hospital, New Delhi, India

• D K Chauhan, MBBS · Dr D.K. Chauhan, New Delhi, India

• Mahip Saluja, M.D · Dr. Mahip Saluja Clinic, Meerut, U.P. India

• Neeraj Gupta, MD · Dr. Neeraj Gupta, Firozabad ,U.P, India

• Subodh Katiyar, MD · Dr Subodh, Swaroop Nagar,Kanpur, India

• Nirmal K Jain, MD · Dr.Nirmal Kumar Jain, Jaipur, India

• Komal Gupta, M.D · Kilkari , Lucknow , India

• Fahad Khan, MD · New City Hospital and Trauma Centre, Lucknow, India

• Vaibhav Gupta, MD · Saanvi MultiSpeciality Clinic, Moradabad, UP, India,

• Suraj P Sondhi, MD · Dr. S. P. Sondhi Clinic , Meerut U.P India

• Siddharth Agarwal, MD · Siddharth Nursing Home, Agra, U.P India

• Sanjay Teotia, M.D · Dr. Sanjay Teotia Clinic, Meerut, U.P , India

• S PS Chauhan, MD · Dr. SPS Chauhan, Firozabad, U.P-India,

• Mahesh Mishra, MD · Mahatma Gandhi Medical College& Hospital , Jaipur, India

• Ashish Rohatgi, DTCD · Ish Medical Centre and Respiratory Lab, New Delhi- India

• Om P Rai, MD · Guru Tej Bahadur Hospital, Kanpur India

• Pawan Varshneya, MD · Varshneya Chest Clinic & Eye Care Centre, Aligarh, UP India

• R K Garg, MD · Dr. R. K. Garg's Clinic, U.P, India

• Vinod K Karhana, M.D · Prakash Devi Memorial Medical Centre,New Delhi, India

• Vijay K Khurana, M.D · Ram-Tej Hospital, Agra, India

• Surya Kant, MD, FCCP, FNCP, FCAI · Dr.Surya Kant, Lucknow, India

• Shalini Arya, MD · Arya Chest Clinic, Meerut, UP,India

• Ashok K Singh, MD, FCCP, FCCS · Pulmonary Care and Sleep Clinic, Kanpur, India

• Bhanu P Singh, MD, FCCP · Surya Chest Foundation, Lucknow India

• Chandra P Singh, MD · Jigyasa Medical Center,Uttar Pradesh, India

• Arun Aggarwal, MD · Indra Nursing Home and Maternity Centre, Uttar Pradesh, India

• Anjula Bhargava, MS · Rajul Nursing Home, Sasni Gate, Aligarh, UP India

• Angela Crook · MRC Clinical Trials Unit

• Salome Charalambous · The Aurum Institute, Tembisa Hospital, South Africa

• Lerato Mohapi · Soweto Perinatal HIV Research Unit, Johannesburg, South Africa

• Nesri Padayatchi · Caprisa eThakwini Research Facility, Durban, South Africa

• Sandy Pillay · International Clinical Trials Unit, Durban, South Africa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2013-10-31

Completion

2014-02-28

Countries

• China
• India
• Kenya
• Malaysia
• Mexico
• South Africa
• Tanzania
• Thailand
• Zambia

Study Locations