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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201110000124315 Date registered: 2009/02/10
TRIAL DESCRIPTION
Public title Controlled comparison of two moxifloxacin containing treatment shortening regimens in pulmonary tuberculosis [retrospectively registered]
Official scientific title REMoxTB
Brief summary describing the background
and objectives of the trial
A randomised placebo ¿ controlled double blind trial comparing two treatment shortening regimens with the standard regimen in the treatment of adults with pulmonary tuberculosis
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Tuberculosis ,
Purpose of the trial Treatment
Anticipated trial start date
Actual trial start date 2008-01-01
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 2400   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation: blocks of variable size Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group 2EHRZ/4HR Daily 8 weeks chemotherapy, followed by nine weeks isoniazid plus rifampicin and moxifloxacin placebo followed by nine weeks iso and rif only 633 Placebo
Experimental group 2MHRZ/2MHR Daily 8 weeks chemotherapy, followed by nine weeks isoniazid plus rifampicin and moxifloxacin followed by nine weeks iso placebo and rif placebo 8 weeks chemp (with moxifloxacin, isoniazid, rifampicin and pyrazinamide plus ethambutol placebo); 9 weeks iso, rif and mox; 9 weeks iso placebo and rif placebo 633
Experimental group 2EMRZ/2MR Daily 8 weeks chemotherapy, followed by nine weeks moxifloxacin plus rifampicin and isoniazid placebo followed by nine weeks iso and rif placebo 8 weeks chemp (with moxifloxacin, ethambutol, rifampicin and pyrazinamide plus isoniazid placebo); 9 weeks rif and mox plus iso placebo; 9 weeks iso placebo and rif placebo 633

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1. Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity 2. Two sputum specimens positive for tubercle bacilli on direct smear microscopy at the local laboratory 3. No previous anti-tuberculosis chemotherapy 4. Aged 18 years and over 5. A firm home address that is readily accessible for visiting and willingness to inform the study team of any change of address during the treatment and follow-up period 6. Agreement to participate in the study and to give a sample of blood for Human Immunodeficiency Virus (HIV) testing 7. Laboratory parameters performed up to 14 days before enrolment 8. Serum aspartate aminotransferase (AST) activity less than three times the Upper Limit of Normal (ULN) 9. Serum total bilirubin level less than 2.5 times ULN 10. Creatinine Clearance (CrCl) level greater than 30 mls/min 11. Haemoglobin level of at least 7.0 g/dL 12. Platelet count of at least 50 x 10^9 cells/L 13. Serum potassium greater than 3.5 mmol/L 14. Negative pregnancy test (women of childbearing potential) 15. Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an Intra-Uterine Contraceptive Device (IUCD) in place 1. Unable to take oral medication 2. Previously enrolled in this study 3. Received any investigational drug in the past three months 4. Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs) 5. Any condition that may prove fatal during the first two months of the study period 6. TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome 7. Pre-existing non-tuberculosis disease likely to prejudice the response to, or assessment of, treatment e.g. insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis, chronic diarrhoeal disease 8. Pregnant or breast feeding 9. Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism 10. Contraindications to any medications in the study regimens 11. Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine) 12. End stage liver failure (class Child-Pugh C) 13. Uncorrected hypokalaemia 14. Weight less than 35 kg 15. Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones 16. HIV infection with CD4 count less than 250 x 10^9/lit 17. Patients already receiving anti-retroviral therapy 18. Patients whose initial isolate is shown to be multiple drug resistant 18 nulls 999 nulls Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2006/05/01 UCL Graduate School, University College London, North cloisters, Wilkins Building
Ethics Committee Address
Street address City Postal code Country
Gower Street London WC1E 6BT United Kingdom

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Efficacy : Combined failure of bacteriological cure and relapse within one year of completion of therapy 2. Safety: Proportion of patients with grade three or four Adverse Events (AE's) according to the World Health Organisation (WHO) grade During study analyses

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UCT Lung Institue (University of Cape Town) George Street Cape Town Cape Town 7700 South Africa
Unit for clinical & Biomedical TB Research, Medical Research Council 491 Ridge Road Durban Durban 4001 South Africa
Department of Internal Medicine, School of Medicine University of Zambia & University Teaching Hospital Lusaka Box 50110 Zambia

FUNDING SOURCES
Name of source Street address City Postal code Country
TB Alliance (USA) 40 Wall Street New York NY 10005 United States of America
Bayer HealthCare Pharmaceuticals (USA) 6 West Belt Wayne NJ 07470 United States of America
European and Developing Countries Clinical Trials Partnership 2509 AA The Hague P.O. Box 93015 Netherlands
TB Alliance (USA) 40 Wall Street New York NY 10005 United States of America
Bayer HealthCare Pharmaceuticals (USA) 6 West Belt Wayne NJ 07470 United States of America
European and Developing Countries Clinical Trials Partnership 2509 AA The Hague P.O. Box 93015 Netherlands

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre for Medical Microbiology , Royal Free and University College Medical School, Hampstead Campus, Rowland Hill Street Gower Street London WC1E 6BT United Kingdom University
Primary Sponsor Centre for Medical Microbiology , Royal Free and University College Medical School, Hampstead Campus, Rowland Hill Street Gower Street London WC1E 6BT United Kingdom University

COLLABORATORS
Name Street address City Postal code Country
Triclinium 4th Floor 135 West Street Northlands PO Box 55132 South Africa
MRC 222 Euston Road London NW1 2DA United Kingdom
PharmaNet Ltd. Buckingham Court, High Wycombe London HP11 1JU United Kingdom
Triclinium 4th Floor 135 West Street Northlands PO Box 55132 South Africa
MRC 222 Euston Road London NW1 2DA United Kingdom
PharmaNet Ltd. Buckingham Court, High Wycombe London HP11 1JU United Kingdom

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Stephen Gillespie shg3@st-andrews.ac.uk +44 1334 476161
Street address City Postal code Country Position / Affiliation
University of St Andrews St Andrews, Fife KY16 9AJ United Kingdom Prof of Medicine
Role Name Email Phone Fax
Public Enquiries Mr Matt Betteridge m.betteridge@ucl.ac.uk +44 207 679 6502
Street address City Postal code Country Position / Affiliation
Gower Street London WC1E 6BT Senior Trial Manager
Role Name Email Phone Fax
Scientific Enquiries Mr Matt Betteridge m.betteridge@ucl.ac.uk +44 207 679 6502
Street address City Postal code Country Position / Affiliation
Gower Street London WC1E 6BT United Kingdom