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: pactr.samrc.ac.za
Trial no.: PACTR2008060000861040 Date of Approval: 27/06/2008
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/07/2007
Actual trial start date 15/08/2008
Anticipated date of last follow up 31/07/2012
Actual Last follow-up date 31/07/2012
Anticipated target sample size (number of participants) 1100
Actual target sample size (number of participants) 827
Recruitment status Completed
Publication URL http://www.nejm.org/doi/full/10.1056/NEJMoa1314210#t=article
Secondary Ids Issuing authority/Trial register
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)
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-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 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 17/03/2008 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
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
Primary Outcome Combined rate of failure at the end of treatment and relapse, 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
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
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
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
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
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 Street address
Principal Investigator Amina Jindani ajindani@sgul.ac.uk +4420 8725 2801 Centre for Infection Department of Cellular and Molecular Medicine St. George¿s, University of London Jenner Wing, Cranmer Terrace
City Postal code Country Position/Affiliation
London SW17 0RE United Kingdom Chief Investigator
Role Name Email Phone Street address
Public Enquiries Karen Sanders KSanders@ctu.mrc.ac.uk +44 207670 4749 MRC CTU, 125 Kingsway
City Postal code Country Position/Affiliation
London WC2B United Kingdom
Role Name Email Phone Street address
Scientific Enquiries Amina Jindani ajindani@sgul.ac.uk +4420 8725 2801 Centre for Infection Department of Cellular and Molecular Medicine St. George¿s, University of London Jenner Wing, Cranmer Terrace
City Postal code Country Position/Affiliation
London SW17 0RE United Kingdom Chief Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information