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

Primary Purpose

Pulmonary Tuberculosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin
Sponsored by
Global Alliance for TB Drug Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity.
  • 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:

  • Unable to take oral medication.
  • 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).

Sites / Locations

  • Beijing Tuberculosis and Thoracic Tumor Research Institute
  • Shanghai Pulmonary Hospital
  • TB Institute
  • Nirmal Kumar Jain
  • Mahatma Gandhi Medical College& Hospital
  • Ram-Tej Hospital,
  • Siddharth Nursing Home,
  • Rajul Nursing Home
  • Varshneya Chest Clinic & Eye Care Centre
  • Dr. Neeraj Gupta Clinic
  • S.P.S Chauhan Clinic
  • Dr. R. K. Garg's Clinic,
  • Indra Nursing Home and Maternity Centre
  • Dr. AK Singh Clinic
  • Dr. S. K. Katiyar, Swaroop Nagar,
  • Guru Tej Bahadur Hospital
  • Dr. Komal Gupta
  • New City Hospital and Trauma Centre,
  • Surya Chest Foundation,
  • Surya Kant Clinic
  • Dr. Mahip Saluja Clinic, U.P.
  • Arya Chest Clinic, UP,India
  • Dr. S. P. Sondhi Clinic,
  • Sri Ram Plaza
  • Jigyasa Medical Center
  • Saanvi MultiSpeciality Clinic,
  • A-One Hospital
  • Dr. D.K. Chauhan
  • Centre for advanced lung and sleep disorders
  • Dr. Mittal's clinic
  • Diligent Hospital
  • Ish Medical Centre and Respiratory Lab,
  • Smt Prakash Devi Memorial Medical Centre,
  • Centre for Respiratory Disease Research at KEMRI
  • Institute of Respiratory Medicine (IPR) Jalan Pahang
  • Hospital General de Occidente de la secretaria
  • Madibeng centre for Research, 40 Pienaar Street,
  • Clinical HIV Research Unit (CHRU)
  • Centre for TB Research and Innovation, University of Cape Town Lung Institute
  • Tiervlei Trial Center and University of Stellenbosch
  • Unit for Clinical & Biomedical TB Research, MRC Durban
  • NIMR Mbeya Medical Research Programme
  • Kilimanjaro Christian Medical Centre
  • Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University
  • Chest Disease Institute (CDI), Ministry of Public,
  • Rajavithi Hospital, Division Of Pulmonary Medicine
  • University Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Regimen 1 - 2EHRZ/4HR (control regimen)

Regimen 2 - 2MHRZ/2MHR

Regimen 3 - 2EMRZ/2MR

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ).
The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results.
Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting)
The number of participants includes all patients who had at least one grade 3 or 4 adverse event.

Secondary Outcome Measures

Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT).
The secondary analysis of efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome) based on MGIT. Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis.
Number of Patients Who Are Culture Negative (Solid LJ Culture)
Number of patients who are TB LJ culture negative at 8 weeks.
Number of Patients Who Are Culture Negative (Liquid MGIT Culture)
Number of patients who are TB MGIT culture negative at 8 weeks.
Time to First Culture Negative Sputum Sample (LJ Solid Media)
Culture negative for TB using LJ cultures.
Time to First Culture Negative Sputum Sample (MGIT Liquid Media)
Sensitivity Analysis Assuming All Losses to Follow-up and Non-tuberculous Deaths Have an Unfavorable Outcome Using Solid (L-J) Media.
Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Unfavorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result ("isolated positive culture") was followed by at least two negative culture results.
Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculous Deaths Have a Favourable Outcome Using Solid (L-J) Media.
Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Favorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result ("isolated positive culture") was followed by at least two negative culture results.

Full Information

First Posted
March 17, 2009
Last Updated
February 15, 2017
Sponsor
Global Alliance for TB Drug Development
Collaborators
European and Developing Countries Clinical Trials Partnership (EDCTP), University College, London, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00864383
Brief Title
Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis
Acronym
REMoxTB
Official Title
A Randomised Placebo - Controlled Double Blind Trial Comparing 1) a Two Month Intensive Phase of Ethambutol, Moxifloxacin, Rifampicin, Pyrazinamide Versus the Standard Regimen (Ethambutol, Isoniazid, Rifampicin, Pyrazinamide) and 2) a Treatment Shortening Regimen Comparing Two Months Moxifloxacin, Isoniazid, Rifampicin, Pyrazinamide Followed by Two Months Moxifloxacin, Isoniazid, Rifampicin Versus the Standard Regimen (Two Months Ethambutol, Isoniazid, Rifampicin, Pyrazinamide Followed by Four Months Isoniazid and Rifampicin) for the Treatment of Adults With Pulmonary Tuberculosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Global Alliance for TB Drug Development
Collaborators
European and Developing Countries Clinical Trials Partnership (EDCTP), University College, London, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
The current recommended treatments for tuberculosis (TB) require a patient to take multiple drugs for six to eight months. Because the course of therapy is long, many patients do not adhere to treatment and as a consequence they have a poor outcome. In these cases either the sputum is not cleared of the bacteria causing tuberculosis, or the disease returns again (called relapse). Response to medication can be monitored during treatment by collecting regular sputum samples and examining these samples by culture, for the organisms that cause tuberculosis. 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: 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). 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1931 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen 1 - 2EHRZ/4HR (control regimen)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Regimen 2 - 2MHRZ/2MHR
Arm Type
Experimental
Arm Description
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.
Arm Title
Regimen 3 - 2EMRZ/2MR
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin
Other Intervention Name(s)
Avelox, Avelon, Avalox, Myambutol, Nydrazid, Rifampin, Rifadin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ).
Description
The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results.
Time Frame
18 months (within one year of completion of therapy)
Title
Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting)
Description
The number of participants includes all patients who had at least one grade 3 or 4 adverse event.
Time Frame
18 months (within one year of completion of therapy)
Secondary Outcome Measure Information:
Title
Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT).
Description
The secondary analysis of efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome) based on MGIT. Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis.
Time Frame
18 months (within one year of completion of therapy)
Title
Number of Patients Who Are Culture Negative (Solid LJ Culture)
Description
Number of patients who are TB LJ culture negative at 8 weeks.
Time Frame
8 weeks
Title
Number of Patients Who Are Culture Negative (Liquid MGIT Culture)
Description
Number of patients who are TB MGIT culture negative at 8 weeks.
Time Frame
8 weeks
Title
Time to First Culture Negative Sputum Sample (LJ Solid Media)
Description
Culture negative for TB using LJ cultures.
Time Frame
18 months
Title
Time to First Culture Negative Sputum Sample (MGIT Liquid Media)
Time Frame
18 months
Title
Sensitivity Analysis Assuming All Losses to Follow-up and Non-tuberculous Deaths Have an Unfavorable Outcome Using Solid (L-J) Media.
Description
Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Unfavorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result ("isolated positive culture") was followed by at least two negative culture results.
Time Frame
18 months
Title
Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculous Deaths Have a Favourable Outcome Using Solid (L-J) Media.
Description
Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Favorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result ("isolated positive culture") was followed by at least two negative culture results.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity. 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: Unable to take oral medication. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen H Gillespie, MB BCh BAO MD DSc
Organizational Affiliation
University of St Andrews
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrew Nunn, BSc MSc
Organizational Affiliation
MRC Clinical Trials Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah K Meredith, MB BS MSc
Organizational Affiliation
MRC Clinical Trials Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy D McHugh, BSc PhD CSi
Organizational Affiliation
Centre for Medical Microbiology, Royal Free and University College Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Zumla, BSc MBChB MSc PhD
Organizational Affiliation
Centre for International Health, Royal Free and University College Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Pym, MB BMRCP PhD
Organizational Affiliation
Unit for Clinical & Biomedical TB Research, MRC Durban
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Mwaba, MB ChB MMed PhD
Organizational Affiliation
University Teaching Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noel Sam, MMed MD
Organizational Affiliation
Kilimanjaro Christian Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Diacon, BM MD
Organizational Affiliation
Tiervlei Trial Center and University of Stellenbosch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodney Dawson, MB ChB FCP
Organizational Affiliation
Centre for TB Research and Innovation, UCT Lung Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evans Amukoye, MBChB. Mmed (Paediatric)
Organizational Affiliation
Centre for Respiratory Disease Research at KEMRI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonard Maboko, MD MSc PhD
Organizational Affiliation
NIMR - Mbeya Medical Research Programme
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian Sanne, MBBCH FCP(SA)
Organizational Affiliation
Clinical HIV Research Unit (CHRU), Westdene
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheryl Louw, MBChB
Organizational Affiliation
Madibeng Centre For Research, Brits
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mengqui Gao, MD
Organizational Affiliation
Beijing Tuberculosis and Thoracic Tumor Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qing Zhang, MD
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiexiu Wang, MD
Organizational Affiliation
TB Institute, Tianjin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aziah Mahayiddin, MD
Organizational Affiliation
Institute of Respiratory Medicine (IPR) Jalan Pahang, Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Watchara Boonsawat, MD PhD
Organizational Affiliation
Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charoen Chuchottaworn, MD
Organizational Affiliation
Chest Disease Institute (CDI), Ministry of Public Health, Nonthaburi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pairaj Kateruttanakul, MD
Organizational Affiliation
Rajavithi Hospital, Division of Pulmonary, Department of Medicine, Bangkok
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerardo Amaya-Tapia, MD
Organizational Affiliation
Hospital General de occidente de la secretaria, Seattle, Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Murray, M.D, PhD
Organizational Affiliation
Global Alliance for TB Drug Development
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Brown, BA, BM, BCh, MRCP, PhD, DTM&H
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rakesh Lal, MD
Organizational Affiliation
Centre for Advanced Lung and Sleep Disorders, New Delhi, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rakesh Mittal, MBBS MD
Organizational Affiliation
Dr. Mittal's Clinic, Balaji Medical Store, New Delhi, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A K Jain, MBBS FICA
Organizational Affiliation
Diligent Hospital, New Delhi, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahesh Kapoor, MBBS DTCD
Organizational Affiliation
A One Hospital, New Delhi, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
D K Chauhan, MBBS
Organizational Affiliation
Dr D.K. Chauhan, New Delhi, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahip Saluja, M.D
Organizational Affiliation
Dr. Mahip Saluja Clinic, Meerut, U.P. India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neeraj Gupta, MD
Organizational Affiliation
Dr. Neeraj Gupta, Firozabad ,U.P, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Subodh Katiyar, MD
Organizational Affiliation
Dr Subodh, Swaroop Nagar,Kanpur, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nirmal K Jain, MD
Organizational Affiliation
Dr.Nirmal Kumar Jain, Jaipur, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Komal Gupta, M.D
Organizational Affiliation
Kilkari , Lucknow , India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fahad Khan, MD
Organizational Affiliation
New City Hospital and Trauma Centre, Lucknow, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vaibhav Gupta, MD
Organizational Affiliation
Saanvi MultiSpeciality Clinic, Moradabad, UP, India,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suraj P Sondhi, MD
Organizational Affiliation
Dr. S. P. Sondhi Clinic , Meerut U.P India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Siddharth Agarwal, MD
Organizational Affiliation
Siddharth Nursing Home, Agra, U.P India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjay Teotia, M.D
Organizational Affiliation
Dr. Sanjay Teotia Clinic, Meerut, U.P , India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S PS Chauhan, MD
Organizational Affiliation
Dr. SPS Chauhan, Firozabad, U.P-India,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahesh Mishra, MD
Organizational Affiliation
Mahatma Gandhi Medical College& Hospital , Jaipur, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashish Rohatgi, DTCD
Organizational Affiliation
Ish Medical Centre and Respiratory Lab, New Delhi- India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Om P Rai, MD
Organizational Affiliation
Guru Tej Bahadur Hospital, Kanpur India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pawan Varshneya, MD
Organizational Affiliation
Varshneya Chest Clinic & Eye Care Centre, Aligarh, UP India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R K Garg, MD
Organizational Affiliation
Dr. R. K. Garg's Clinic, U.P, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vinod K Karhana, M.D
Organizational Affiliation
Prakash Devi Memorial Medical Centre,New Delhi, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vijay K Khurana, M.D
Organizational Affiliation
Ram-Tej Hospital, Agra, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Surya Kant, MD, FCCP, FNCP, FCAI
Organizational Affiliation
Dr.Surya Kant, Lucknow, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shalini Arya, MD
Organizational Affiliation
Arya Chest Clinic, Meerut, UP,India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashok K Singh, MD, FCCP, FCCS
Organizational Affiliation
Pulmonary Care and Sleep Clinic, Kanpur, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bhanu P Singh, MD, FCCP
Organizational Affiliation
Surya Chest Foundation, Lucknow India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chandra P Singh, MD
Organizational Affiliation
Jigyasa Medical Center,Uttar Pradesh, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arun Aggarwal, MD
Organizational Affiliation
Indra Nursing Home and Maternity Centre, Uttar Pradesh, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anjula Bhargava, MS
Organizational Affiliation
Rajul Nursing Home, Sasni Gate, Aligarh, UP India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela Crook
Organizational Affiliation
MRC Clinical Trials Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salome Charalambous
Organizational Affiliation
The Aurum Institute, Tembisa Hospital, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lerato Mohapi
Organizational Affiliation
Soweto Perinatal HIV Research Unit, Johannesburg, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nesri Padayatchi
Organizational Affiliation
Caprisa eThakwini Research Facility, Durban, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandy Pillay
Organizational Affiliation
International Clinical Trials Unit, Durban, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tuberculosis and Thoracic Tumor Research Institute
City
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
TB Institute
City
Tianjin
ZIP/Postal Code
300041
Country
China
Facility Name
Nirmal Kumar Jain
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Mahatma Gandhi Medical College& Hospital
City
Jaipur
State/Province
Rajsthan
Country
India
Facility Name
Ram-Tej Hospital,
City
Agra
State/Province
Uttar Pradesh
Country
India
Facility Name
Siddharth Nursing Home,
City
Agra
State/Province
Uttar pradesh
Country
India
Facility Name
Rajul Nursing Home
City
Aligarh
State/Province
Uttar Pradesh
Country
India
Facility Name
Varshneya Chest Clinic & Eye Care Centre
City
Aligarh
State/Province
Uttar Pradesh
Country
India
Facility Name
Dr. Neeraj Gupta Clinic
City
Firozabad
State/Province
Uttar Pradesh
Country
India
Facility Name
S.P.S Chauhan Clinic
City
Firozabad
State/Province
Uttar Pradesh
Country
India
Facility Name
Dr. R. K. Garg's Clinic,
City
Gaziabad
State/Province
Uttar Pradesh
ZIP/Postal Code
2011002
Country
India
Facility Name
Indra Nursing Home and Maternity Centre
City
Ghaziabad
State/Province
Uttar Pradesh
Country
India
Facility Name
Dr. AK Singh Clinic
City
Kanpur
State/Province
Uttar Pradesh
Country
India
Facility Name
Dr. S. K. Katiyar, Swaroop Nagar,
City
Kanpur
State/Province
Uttar Pradesh
Country
India
Facility Name
Guru Tej Bahadur Hospital
City
Kanpur
State/Province
Uttar Pradesh
Country
India
Facility Name
Dr. Komal Gupta
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
New City Hospital and Trauma Centre,
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Surya Chest Foundation,
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Surya Kant Clinic
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Dr. Mahip Saluja Clinic, U.P.
City
Meerut,
State/Province
Uttar Pradesh
Country
India
Facility Name
Arya Chest Clinic, UP,India
City
Meerut
State/Province
Uttar Pradesh
Country
India
Facility Name
Dr. S. P. Sondhi Clinic,
City
Meerut
State/Province
Uttar Pradesh
Country
India
Facility Name
Sri Ram Plaza
City
Meerut
State/Province
Uttar Pradesh
Country
India
Facility Name
Jigyasa Medical Center
City
Moradabad
State/Province
Uttar Pradesh
Country
India
Facility Name
Saanvi MultiSpeciality Clinic,
City
Moradabad
State/Province
Uttar Pradesh
Country
India
Facility Name
A-One Hospital
City
Delhi
ZIP/Postal Code
110087
Country
India
Facility Name
Dr. D.K. Chauhan
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Centre for advanced lung and sleep disorders
City
New Delhi
ZIP/Postal Code
110026
Country
India
Facility Name
Dr. Mittal's clinic
City
New Delhi
ZIP/Postal Code
110043
Country
India
Facility Name
Diligent Hospital
City
New Delhi
ZIP/Postal Code
110062
Country
India
Facility Name
Ish Medical Centre and Respiratory Lab,
City
New Delhi
Country
India
Facility Name
Smt Prakash Devi Memorial Medical Centre,
City
New Delhi
Country
India
Facility Name
Centre for Respiratory Disease Research at KEMRI
City
Nairobi
Country
Kenya
Facility Name
Institute of Respiratory Medicine (IPR) Jalan Pahang
City
Kuala Lumpur
ZIP/Postal Code
53000
Country
Malaysia
Facility Name
Hospital General de Occidente de la secretaria
City
Guadalajara
State/Province
Seattle
ZIP/Postal Code
45170
Country
Mexico
Facility Name
Madibeng centre for Research, 40 Pienaar Street,
City
Madibeng
State/Province
Brits
ZIP/Postal Code
0250
Country
South Africa
Facility Name
Clinical HIV Research Unit (CHRU)
City
Johannesburg
State/Province
Westdene
ZIP/Postal Code
2092
Country
South Africa
Facility Name
Centre for TB Research and Innovation, University of Cape Town Lung Institute
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Tiervlei Trial Center and University of Stellenbosch
City
Cape Town
Country
South Africa
Facility Name
Unit for Clinical & Biomedical TB Research, MRC Durban
City
Durban
Country
South Africa
Facility Name
NIMR Mbeya Medical Research Programme
City
Mbeya
Country
Tanzania
Facility Name
Kilimanjaro Christian Medical Centre
City
Moshi
Country
Tanzania
Facility Name
Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University
City
Khon Kaen
State/Province
Mueang
ZIP/Postal Code
40200
Country
Thailand
Facility Name
Chest Disease Institute (CDI), Ministry of Public,
City
Nonthaburi
State/Province
Mueang
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Rajavithi Hospital, Division Of Pulmonary Medicine
City
Bangkok
State/Province
Phayathai
ZIP/Postal Code
10400
Country
Thailand
Facility Name
University Teaching Hospital
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24461758
Citation
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.
Results Reference
background
PubMed Identifier
24429244
Citation
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.
Results Reference
background
PubMed Identifier
25196020
Citation
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.
Results Reference
result
PubMed Identifier
29779774
Citation
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.
Results Reference
derived
PubMed Identifier
26847437
Citation
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. Erratum In: BMC Med. 2016;14:36. Crook, Angela [corrected to Crook, Angela M].
Results Reference
derived

Learn more about this trial

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

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