Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis
NCT ID: NCT00864383
Last Updated: 2017-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1931 participants
INTERVENTIONAL
2008-01-31
2014-02-28
Brief Summary
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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.
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Detailed Description
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The commonly used drugs to treat tuberculosis are rifampicin, isoniazid, ethambutol and pyrazinamide. Previous studies in animals and in humans suggest that a new drug called moxifloxacin may also be an effective treatment in tuberculosis. Moreover, promising laboratory studies on mice suggest that moxifloxacin may enable the total duration of chemotherapy to be reduced to four months, which would be a significant improvement for patients taking medication for tuberculosis.
This study will involve comparisons that are designed to assess whether substituting moxifloxacin for individual drugs in existing treatment combinations will enable tuberculosis treatment to be shortened. Patients selected for the study will be allocated to one of three treatment groups. The first group will be given six months standard treatment. A second group will receive moxifloxacin substituted for ethambutol, as part of a four month regimen, to see whether the shorter treatment is not inferior to the standard six month treatment. The third group will receive moxifloxacin substituted for isoniazid, as part of a four month regimen, to see whether the shorter treatment is not inferior to the standard six month treatment.
Hypotheses:
1. In treatment-naïve adults with active pulmonary TB treated with eight weeks of moxifloxacin (M), isoniazid (H), rifampicin (R) and pyrazinamide (Z) (i.e. a standard regimen where moxifloxacin is substituted for ethambutol (E)), followed by nine weeks of moxifloxacin, isoniazid and rifampicin, followed by nine weeks of placebo, the proportion of patients who experience treatment failure or disease relapse in the twelve months following treatment completion will not be inferior to that observed in patients who are treated with a standard regimen (eight weeks of ethambutol, isoniazid, rifampicin and pyrazinamide followed by eighteen weeks of isoniazid plus rifampicin) (Comparison 1).
2. In treatment-naïve adults with active pulmonary TB treated with eight weeks of ethambutol, moxifloxacin, rifampicin and pyrazinamide (i.e. a standard regimen where moxifloxacin is substituted for isoniazid), followed by nine weeks of moxifloxacin and rifampicin followed by nine weeks of placebo, the proportion of patients who experience treatment failure or disease relapse in the twelve months following treatment completion will not be inferior to that observed in patients who are treated with a standard regimen (eight weeks of ethambutol, isoniazid, rifampicin and pyrazinamide followed by eighteen weeks of isoniazid plus rifampicin) (Comparison 2).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Regimen 1 - 2EHRZ/4HR (control regimen)
* Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by
* Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by
* Nine weeks of Isoniazid and Rifampicin only.
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.
Regimen 2 - 2MHRZ/2MHR
* Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by
* Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by
* Nine weeks of the Isoniazid placebo and the Rifampicin placebo.
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.
Regimen 3 - 2EMRZ/2MR
* Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by
* Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by
* Nine weeks of the Isoniazid placebo and the Rifampicin placebo
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Two sputum specimens positive for tubercle bacilli on smear microscopy at least one of which must be processed and positive at the study laboratory.
* Aged 18 years or over.
* No previous anti-tuberculosis chemotherapy.
* 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.
* Agreement to participate in the study and to give a sample of blood for HIV testing (see appendices 1 \& 2).
* Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an IUCD in place.
* Laboratory parameters performed up to 14 days before enrolment.
* Serum aspartate transaminase (AST) and alanine transaminase (ALT) activity less than 3 times the upper limit of normal.
* Serum total bilirubin level less than 2.5 times upper limit of normal. Creatinine clearance (CrCl) level greater than 30 mls/min.
* Haemoglobin level of at least 7.0 g/dL.
* Platelet count of at least 50x109cells/L.
* Serum potassium greater than 3.5 mmol/L.
* Negative pregnancy test (women of childbearing potential).
Exclusion Criteria
* Previously enrolled in this study.
* Received any investigational drug in the past 3 months.
* Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs).
* Any condition that may prove fatal during the first two months of the study period.
* TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome
* Pre-existing non-tuberculosis disease e.g. diabetes, liver or kidney disease, blood disorders,peripheral neuritis, chronic diarrhoeal disease in which the current clinical condition of the patient is likely to prejudice the response to, or assessment of treatment.
* Pregnant or breast feeding.
* Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism.
* Contraindications to any medications in the study regimens.
* 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).
* Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones.
* Patients already receiving anti-retroviral therapy.
* Patients whose initial isolate is shown to be multiple drug resistant (i.e. resistant to rifampicin and isoniazid) or monoresistant to rifampicin, or resistant to any fluoroquinolone)
* Weight less than 35kg
* HIV infection with CD4 count less than 250 cells/µL.
* End stage liver failure (class Child-Pugh C).
18 Years
ALL
No
Sponsors
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European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
University College, London
OTHER
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
INDUSTRY
Sanofi
INDUSTRY
Global Alliance for TB Drug Development
OTHER
Responsible Party
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Principal Investigators
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Stephen H Gillespie, MB BCh BAO MD DSc
Role: STUDY_DIRECTOR
University of St Andrews
Andrew Nunn, BSc MSc
Role: PRINCIPAL_INVESTIGATOR
MRC Clinical Trials Unit
Sarah K Meredith, MB BS MSc
Role: PRINCIPAL_INVESTIGATOR
MRC Clinical Trials Unit
Timothy D McHugh, BSc PhD CSi
Role: PRINCIPAL_INVESTIGATOR
Centre for Medical Microbiology, Royal Free and University College Medical School
Ali Zumla, BSc MBChB MSc PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for International Health, Royal Free and University College Medical School
Alexander Pym, MB BMRCP PhD
Role: PRINCIPAL_INVESTIGATOR
Unit for Clinical & Biomedical TB Research, MRC Durban
Peter Mwaba, MB ChB MMed PhD
Role: PRINCIPAL_INVESTIGATOR
University Teaching Hospital
Noel Sam, MMed MD
Role: PRINCIPAL_INVESTIGATOR
Kilimanjaro Christian Medical Centre
Andreas Diacon, BM MD
Role: PRINCIPAL_INVESTIGATOR
Tiervlei Trial Center and University of Stellenbosch
Rodney Dawson, MB ChB FCP
Role: PRINCIPAL_INVESTIGATOR
Centre for TB Research and Innovation, UCT Lung Institute
Evans Amukoye, MBChB. Mmed (Paediatric)
Role: PRINCIPAL_INVESTIGATOR
Centre for Respiratory Disease Research at KEMRI
Leonard Maboko, MD MSc PhD
Role: PRINCIPAL_INVESTIGATOR
NIMR - Mbeya Medical Research Programme
Ian Sanne, MBBCH FCP(SA)
Role: PRINCIPAL_INVESTIGATOR
Clinical HIV Research Unit (CHRU), Westdene
Cheryl Louw, MBChB
Role: PRINCIPAL_INVESTIGATOR
Madibeng Centre For Research, Brits
Mengqui Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tuberculosis and Thoracic Tumor Research Institute
Qing Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Xiexiu Wang, MD
Role: PRINCIPAL_INVESTIGATOR
TB Institute, Tianjin
Aziah Mahayiddin, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Respiratory Medicine (IPR) Jalan Pahang, Malaysia
Watchara Boonsawat, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University
Charoen Chuchottaworn, MD
Role: PRINCIPAL_INVESTIGATOR
Chest Disease Institute (CDI), Ministry of Public Health, Nonthaburi
Pairaj Kateruttanakul, MD
Role: PRINCIPAL_INVESTIGATOR
Rajavithi Hospital, Division of Pulmonary, Department of Medicine, Bangkok
Gerardo Amaya-Tapia, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital General de occidente de la secretaria, Seattle, Mexico
Stephen Murray, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Global Alliance for TB Drug Development
Michael Brown, BA, BM, BCh, MRCP, PhD, DTM&H
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Rakesh Lal, MD
Role: PRINCIPAL_INVESTIGATOR
Centre for Advanced Lung and Sleep Disorders, New Delhi, India
Rakesh Mittal, MBBS MD
Role: PRINCIPAL_INVESTIGATOR
Dr. Mittal's Clinic, Balaji Medical Store, New Delhi, India
A K Jain, MBBS FICA
Role: PRINCIPAL_INVESTIGATOR
Diligent Hospital, New Delhi, India
Mahesh Kapoor, MBBS DTCD
Role: PRINCIPAL_INVESTIGATOR
A One Hospital, New Delhi, India
D K Chauhan, MBBS
Role: PRINCIPAL_INVESTIGATOR
Dr D.K. Chauhan, New Delhi, India
Mahip Saluja, M.D
Role: PRINCIPAL_INVESTIGATOR
Dr. Mahip Saluja Clinic, Meerut, U.P. India
Neeraj Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
Dr. Neeraj Gupta, Firozabad ,U.P, India
Subodh Katiyar, MD
Role: PRINCIPAL_INVESTIGATOR
Dr Subodh, Swaroop Nagar,Kanpur, India
Nirmal K Jain, MD
Role: PRINCIPAL_INVESTIGATOR
Dr.Nirmal Kumar Jain, Jaipur, India
Komal Gupta, M.D
Role: PRINCIPAL_INVESTIGATOR
Kilkari , Lucknow , India
Fahad Khan, MD
Role: PRINCIPAL_INVESTIGATOR
New City Hospital and Trauma Centre, Lucknow, India
Vaibhav Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
Saanvi MultiSpeciality Clinic, Moradabad, UP, India,
Suraj P Sondhi, MD
Role: PRINCIPAL_INVESTIGATOR
Dr. S. P. Sondhi Clinic , Meerut U.P India
Siddharth Agarwal, MD
Role: PRINCIPAL_INVESTIGATOR
Siddharth Nursing Home, Agra, U.P India
Sanjay Teotia, M.D
Role: PRINCIPAL_INVESTIGATOR
Dr. Sanjay Teotia Clinic, Meerut, U.P , India
S PS Chauhan, MD
Role: PRINCIPAL_INVESTIGATOR
Dr. SPS Chauhan, Firozabad, U.P-India,
Mahesh Mishra, MD
Role: PRINCIPAL_INVESTIGATOR
Mahatma Gandhi Medical College& Hospital , Jaipur, India
Ashish Rohatgi, DTCD
Role: PRINCIPAL_INVESTIGATOR
Ish Medical Centre and Respiratory Lab, New Delhi- India
Om P Rai, MD
Role: PRINCIPAL_INVESTIGATOR
Guru Tej Bahadur Hospital, Kanpur India
Pawan Varshneya, MD
Role: PRINCIPAL_INVESTIGATOR
Varshneya Chest Clinic & Eye Care Centre, Aligarh, UP India
R K Garg, MD
Role: PRINCIPAL_INVESTIGATOR
Dr. R. K. Garg's Clinic, U.P, India
Vinod K Karhana, M.D
Role: PRINCIPAL_INVESTIGATOR
Prakash Devi Memorial Medical Centre,New Delhi, India
Vijay K Khurana, M.D
Role: PRINCIPAL_INVESTIGATOR
Ram-Tej Hospital, Agra, India
Surya Kant, MD, FCCP, FNCP, FCAI
Role: PRINCIPAL_INVESTIGATOR
Dr.Surya Kant, Lucknow, India
Shalini Arya, MD
Role: PRINCIPAL_INVESTIGATOR
Arya Chest Clinic, Meerut, UP,India
Ashok K Singh, MD, FCCP, FCCS
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Care and Sleep Clinic, Kanpur, India
Bhanu P Singh, MD, FCCP
Role: PRINCIPAL_INVESTIGATOR
Surya Chest Foundation, Lucknow India
Chandra P Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Jigyasa Medical Center,Uttar Pradesh, India
Arun Aggarwal, MD
Role: PRINCIPAL_INVESTIGATOR
Indra Nursing Home and Maternity Centre, Uttar Pradesh, India
Anjula Bhargava, MS
Role: PRINCIPAL_INVESTIGATOR
Rajul Nursing Home, Sasni Gate, Aligarh, UP India
Angela Crook
Role: PRINCIPAL_INVESTIGATOR
MRC Clinical Trials Unit
Salome Charalambous
Role: PRINCIPAL_INVESTIGATOR
The Aurum Institute, Tembisa Hospital, South Africa
Lerato Mohapi
Role: PRINCIPAL_INVESTIGATOR
Soweto Perinatal HIV Research Unit, Johannesburg, South Africa
Nesri Padayatchi
Role: PRINCIPAL_INVESTIGATOR
Caprisa eThakwini Research Facility, Durban, South Africa
Sandy Pillay
Role: PRINCIPAL_INVESTIGATOR
International Clinical Trials Unit, Durban, South Africa
Locations
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Beijing Tuberculosis and Thoracic Tumor Research Institute
Beijing, , China
Shanghai Pulmonary Hospital
Shanghai, , China
TB Institute
Tianjin, , China
Nirmal Kumar Jain
Jaipur, Rajasthan, India
Mahatma Gandhi Medical College& Hospital
Jaipur, Rajsthan, India
Ram-Tej Hospital,
Agra, Uttar Pradesh, India
Siddharth Nursing Home,
Agra, Uttar Pradesh, India
Rajul Nursing Home
Aligarh, Uttar Pradesh, India
Varshneya Chest Clinic & Eye Care Centre
Aligarh, Uttar Pradesh, India
Dr. Neeraj Gupta Clinic
Firozabad, Uttar Pradesh, India
S.P.S Chauhan Clinic
Firozabad, Uttar Pradesh, India
Dr. R. K. Garg's Clinic,
Ghaziabad, Uttar Pradesh, India
Indra Nursing Home and Maternity Centre
Ghaziabad, Uttar Pradesh, India
Dr. AK Singh Clinic
Kanpur, Uttar Pradesh, India
Dr. S. K. Katiyar, Swaroop Nagar,
Kanpur, Uttar Pradesh, India
Guru Tej Bahadur Hospital
Kanpur, Uttar Pradesh, India
Dr. Komal Gupta
Lucknow, Uttar Pradesh, India
New City Hospital and Trauma Centre,
Lucknow, Uttar Pradesh, India
Surya Chest Foundation,
Lucknow, Uttar Pradesh, India
Surya Kant Clinic
Lucknow, Uttar Pradesh, India
Arya Chest Clinic, UP,India
Meerut, Uttar Pradesh, India
Dr. Mahip Saluja Clinic, U.P.
Meerut, Uttar Pradesh, India
Dr. S. P. Sondhi Clinic,
Meerut, Uttar Pradesh, India
Sri Ram Plaza
Meerut, Uttar Pradesh, India
Jigyasa Medical Center
Morādābād, Uttar Pradesh, India
Saanvi MultiSpeciality Clinic,
Morādābād, Uttar Pradesh, India
A-One Hospital
Delhi, , India
Dr. D.K. Chauhan
New Delhi, , India
Centre for advanced lung and sleep disorders
New Delhi, , India
Dr. Mittal's clinic
New Delhi, , India
Diligent Hospital
New Delhi, , India
Ish Medical Centre and Respiratory Lab,
New Delhi, , India
Smt Prakash Devi Memorial Medical Centre,
New Delhi, , India
Centre for Respiratory Disease Research at KEMRI
Nairobi, , Kenya
Institute of Respiratory Medicine (IPR) Jalan Pahang
Kuala Lumpur, , Malaysia
Hospital General de Occidente de la secretaria
Guadalajara, Seattle, Mexico
Madibeng centre for Research, 40 Pienaar Street,
Madibeng, Brits, South Africa
Clinical HIV Research Unit (CHRU)
Johannesburg, Westdene, South Africa
Centre for TB Research and Innovation, University of Cape Town Lung Institute
Cape Town, , South Africa
Tiervlei Trial Center and University of Stellenbosch
Cape Town, , South Africa
Unit for Clinical & Biomedical TB Research, MRC Durban
Durban, , South Africa
NIMR Mbeya Medical Research Programme
Mbeya, , Tanzania
Kilimanjaro Christian Medical Centre
Moshi, , Tanzania
Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University
Khon Kaen, Mueang, Thailand
Chest Disease Institute (CDI), Ministry of Public,
Nonthaburi, Mueang, Thailand
Rajavithi Hospital, Division Of Pulmonary Medicine
Bangkok, Phayathai, Thailand
University Teaching Hospital
Lusaka, , Zambia
Countries
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References
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Bryant JM, Harris SR, Parkhill J, Dawson R, Diacon AH, van Helden P, Pym A, Mahayiddin AA, Chuchottaworn C, Sanne IM, Louw C, Boeree MJ, Hoelscher M, McHugh TD, Bateson AL, Hunt RD, Mwaigwisya S, Wright L, Gillespie SH, Bentley SD. Whole-genome sequencing to establish relapse or re-infection with Mycobacterium tuberculosis: a retrospective observational study. Lancet Respir Med. 2013 Dec;1(10):786-92. doi: 10.1016/S2213-2600(13)70231-5. Epub 2013 Nov 21.
Friedrich SO, Rachow A, Saathoff E, Singh K, Mangu CD, Dawson R, Phillips PP, Venter A, Bateson A, Boehme CC, Heinrich N, Hunt RD, Boeree MJ, Zumla A, McHugh TD, Gillespie SH, Diacon AH, Hoelscher M; Pan African Consortium for the Evaluation of Anti-tuberculosis Antibiotics (PanACEA). Assessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatment. Lancet Respir Med. 2013 Aug;1(6):462-70. doi: 10.1016/S2213-2600(13)70119-X. Epub 2013 Jul 1.
Gillespie SH, Crook AM, McHugh TD, Mendel CM, Meredith SK, Murray SR, Pappas F, Phillips PP, Nunn AJ; REMoxTB Consortium. Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med. 2014 Oct 23;371(17):1577-87. doi: 10.1056/NEJMoa1407426. Epub 2014 Sep 7.
Weir IR, Dufault SM, Phillips PPJ. Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial. Trials. 2024 Mar 12;25(1):180. doi: 10.1186/s13063-024-07999-w.
Weir IR, Dufault SM, Phillips PP. Estimands for clinical endpoints in Tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial. Res Sq [Preprint]. 2023 Nov 9:rs.3.rs-3486707. doi: 10.21203/rs.3.rs-3486707/v1.
Rachow A, Saathoff E, Mtafya B, Mapamba D, Mangu C, Rojas-Ponce G, Ntinginya NE, Boeree M, Heinrich N, Gillespie SH, Hoelscher M; PanACEA-Consortium. The impact of repeated NALC/NaOH- decontamination on the performance of Xpert MTB/RIF assay. Tuberculosis (Edinb). 2018 May;110:56-58. doi: 10.1016/j.tube.2018.04.001. Epub 2018 Apr 5.
Phillips PP, Mendel CM, Burger DA, Crook AM, Nunn AJ, Dawson R, Diacon AH, Gillespie SH. Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials. BMC Med. 2016 Feb 4;14:19. doi: 10.1186/s12916-016-0565-y.
Other Identifiers
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ISRCTN85595810
Identifier Type: -
Identifier Source: secondary_id
REMoxTB
Identifier Type: -
Identifier Source: org_study_id
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