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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.: PACTR2008060000861040 Date registered: 2008/02/08
TRIAL DESCRIPTION
Public title An international multicentre controlled clinical trial to evaluate high dose rifapentine and a quinolone in the treatment of pulmonary tuberculosis
Official scientific title An international multicentre controlled clinical trial to evaluate high dose rifapentine and a quinolone in the treatment of pulmonary tuberculosis
Brief summary describing the background
and objectives of the trial
Current TB treatment involves taking drugs daily for 6-8 mnths. Although drugs free to patients in low income countries, still involves substantial cost (time and admin)to both the patient and the treatment services. Shortening treatment duration or simplifying treatment administration would benefit patients and treatment services.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) RIFAQUIN
Disease(s) or condition(s) being studied Tuberculosis ,
Purpose of the trial Treatment
Anticipated trial start date 2007-07-26
Actual trial start date 2008-08-15
Anticipated date of last follow up 2012-07-31
Actual date of last follow up 2012-07-31
Anticipated target sample size (number of participants) 1,100   
Actual target sample size (number of participants) 827   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
ISRCTN44153044 ISRCTN

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 Simple randomisation using a randomisation table created by a computer software program (i.e. computer sequence generation) Sealed opaque envelopes and central allocation via telephone or internet Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Moxifloxacin 400mg 4 months and 6 months 1234
Experimental group Rifapentine 900mg and 1200mg 2 months and 4 months 1234
Control group Isoniazid, rifampicin, ethambutol and pyrazinamide Standard dose according to weight band 6 months 1234 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1. Newly diagnosed pulmonary tuberculosis 2. Two sputum specimens positive for tubercle bacilli on direct smear microscopy 3. Either no previous anti-tuberculosis chemotherapy, or less than two weeks of previous chemotherapy 4. Aged 18 years and over 5. A firm home address that is readily accessible for visiting and be intending to remain there during the entire treatment and follow up period 6. Willing to agree to participate in the study and to give a sample of blood for HIV testing 1. Has any condition (except HIV infection) that may prove fatal during the study period 2. Has Tuberculous (TB) meningitis 3. Has pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g., insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis 4. Is female and known to be pregnant, or breast feeding 5. Is suffering from a condition likely to lead to uncooperative behaviour such as psychiatric illness or 18 nulls 100 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 2008/03/17 London-Surrey Borders Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
London United Kingdom

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Presence of Rifamycin Monoresistance (RMR) in relapse cultures of HIV infected patients 5, 6, 7, 8, 9, 10, 11, 12, 15, 18 months on the four-month arm and 7, 8, 9, 10, 11, 12, 15, 18 months on the six-month arm, plus at any unscheduled visit
Primary Outcome Occurrence of serious adverse events at any time during chemotherapy, recorded as they present themselves throughout the course of the trial
Primary Outcome Combined rate of failure at the end of treatment and relapse, 18 months
Secondary Outcome Sputum culture results at two months after the initiation of chemotherapy, measured at all visits
Secondary Outcome Rate of completion of chemotherapy according to the protocol measured at all visits
Secondary Outcome Number of observed doses of chemotherapy ingested measured at all visits
Secondary Outcome Any adverse events recorded as they present themselves throughout the course of the trial

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
BOTUSA Gaborone Botswana
SATVI, INSTITUTE OF INFECTIOUS DISEASE & MOLECULAR MEDICINE UNIVERSITY OF CAPE TOWN, ROOM 2.01, WERNHER BEIT SOUTH, ANZIO ROAD, OBSERVATORY, CAPE TOWN 7925 South Africa
Medical/Malaria Institute at Macha, Macha Mission Hospital P.O. Box 630166, Choma Choma Zambia
Biomedical Research and Training Institute Nicoz House, 29 Samora Machel Ave, Harare Zimbabwe
Provincial Medical Directorate Mashonaland East PO Box 10, Marondera Marondera Zimbabwe
Aurum Institute for Health Research 6th Floor, 47 Main Street, Marshalltown Johannesburg South Africa
Harare City Health Department Harare City, Box 596, Harare Zimbabwe
Tembisa Hospital Johannesburg South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust Euston Road London NW1 United Kingdom
European & Developing Countries Clinical Trials Partneship 334 Laan van Nieux Oost Indie The Hague Netherlands

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor St Georges Hospital Medical School trading as St Georges University of London St. Georges, University of London, Jenner Wing, Cranmer Terrace London SW17 0RE United Kingdom University
Primary Sponsor St Georges Hospital Medical School trading as St Georges University of London St. Georges, University of London, Jenner Wing, Cranmer Terrace London SW17 0RE United Kingdom University

COLLABORATORS
Name Street address City Postal code Country
Janneke van Dijk Macha Medical research Institute, P.O. Box 630166 Choma Zambia
Mark Hatherill SATVI, INSTITUTE OF INFECTIOUS DISEASE & MOLECULAR MEDICINEUNIVERSITY OF CAPE TOWN, ROOM 2.01, WERNHER BEIT SOUTH, ANZIO ROAD, OBSERVATORY Cape Town 7925 South Africa
Janneke van Dijk Macha Medical research Institute, P.O. Box 630166 Choma Zambia
Mark Hatherill SATVI, INSTITUTE OF INFECTIOUS DISEASE & MOLECULAR MEDICINEUNIVERSITY OF CAPE TOWN, ROOM 2.01, WERNHER BEIT SOUTH, ANZIO ROAD, OBSERVATORY Cape Town 7925 South Africa
James Shepherd BOTUSA. P. O. Box 90 Gaborone Botswana
Andrew Nunn MRC Clinical Trials Unit, 125 Kingsway London WC2B United Kingdom
Salome Charalambous Aurum Institute for Health Research, 29 Queens Road, Johannesburg South Africa
Stanley Mungofa Harare City Health Department, Harare City, Box 596 Harare Zimbabwe
Simukai Zizhou Provincial Medical Directorate Mashonaland East, PO Box 10, Marondera Marondera Zambia

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Amina Jindani ajindani@sgul.ac.uk +4420 8725 2801 +4420 8672 0234
Street address City Postal code Country Position / Affiliation
Centre for Infection Department of Cellular and Molecular Medicine St. George¿s, University of London Jenner Wing, Cranmer Terrace London SW17 0RE United Kingdom Chief Investigator
Role Name Email Phone Fax
Public Enquiries Ms Karen Sanders KSanders@ctu.mrc.ac.uk +44 207670 4749 +44 207670 4829
Street address City Postal code Country Position / Affiliation
MRC CTU, 125 Kingsway London WC2B United Kingdom
Role Name Email Phone Fax
Scientific Enquiries Dr Amina Jindani ajindani@sgul.ac.uk +4420 8725 2801 +4420 8672 0234
Street address City Postal code Country Position / Affiliation
Centre for Infection Department of Cellular and Molecular Medicine St. George¿s, University of London Jenner Wing, Cranmer Terrace London SW17 0RE United Kingdom Chief Investigator