Pulmonary TuberculosisPhase 2NC-003NCT01691534
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
A Phase 2 study testing TMC207 (J), PA-824 (PA) and pyrazinamide (Z) in people with Pulmonary Tuberculosis, run by Global Alliance for TB Drug Development at 2 sites in South Africa.
Trial summary
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824 plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus Clofazimine, Pyrazinamide alone, Clofazimine… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- TMC207 (J), PA-824 (PA) and pyrazinamide (Z)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Oct 2012to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Provide written, informed consent prior to all trial-related procedures including HIV testing.
- 2. Male or female, aged between 18 and 65 years inclusive.
- 3. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
- 4. Newly diagnosed, previously untreated, sputum smear-positive pulmonary TB.
- 5. A chest X-ray picture which in the opinion of the Investigator is compatible with TB.
- 6. Sputum positive GeneXpert or TB Smear from TB clinic or site initial diagnosis
Show all 17Show fewer
- 7. Sputum positive on direct microscopy for acid-fast bacilli (at least 1+ on the IUATLD/WHO scale).
- 8. Ability to produce an adequate volume of sputum as estimated from a spot assessment (estimated 10 ml or more overnight production).
- 9. Be of non-childbearing potential or using an effective method of birth control as defined as:
- Non-childbearing potential:
- Subject - Not heterosexually active or practice sexual abstinence or
- Female subject/sexual bilateral oophorectomy, bilateral tubal ligation, and/or hysterectomy or has been postmenopausal with a history of no menses for at least 12 consecutive months) or
- Male subject/sexual partner - vasectomised or has had a bilateral orchidectomy minimally three month prior to screening
- Effective birth control methods:
- Double barrier method which can include a male condom, diaphragms, cervical cap, or female condom or
- Barrier method combined with hormone based contraceptives or an intra-uterine device for the female partner and are willing to continue practicing birth control methods throughout treatment and for 12 weeks (male participants) or 6 months (female participants) after the last dose of study medication or discontinuation from study medication in case of premature discontinuation
- (Note: Hormone-based contraception alone may not be reliable when taking IMP; therefore, hormone-based contraceptives alone cannot be used by female participants to prevent pregnancy).
Who cannot join
- Evidence of clinically significant (as judged by the investigator), metabolic, gastrointestinal, cardiovascular, musculoskeletal, ophthalmological, pulmonary, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied) including malaria.
- Poor general condition where any delay in treatment cannot be tolerated per discretion of the Investigator.
- A history of previous TB.
- Clinically significant evidence of extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator.
- History of allergy to the IMP or related substances.
- Isoniazid-resistant and/or Rifampicin-resistant bacteria detected with a sputum specimen collected within the pre-treatment period and tested at the study laboratory.
Show all 46Show fewer
- Known or suspected, current or history of within the past 2 years, alcohol or drug abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the participant.
- HIV infected participants:
- having a CD4+ count <200 cells/µL;
- or having received antiretroviral therapy medication within the last 90 days;
- or having received oral or intravenous antifungal medication within the last 90 days;
- or with an AIDS-defining opportunistic infection or malignancies (except pulmonary TB).
- Having participated in other clinical studies with investigational agents within 8 weeks prior to trial start.
- Significant cardiac arrhythmia requiring medication.
- Participants with the following at screening. For ECGs, central cardiology overread and the mean of triplicate reading must be used:
- Marked prolongation of QT/QTc interval, e.g., confirmed demonstration of QTcF (Fridericia correction) or QTcB (Bazett correction) interval >450 ms at screening;
- History of additional risk factors for Torsade de Pointes, e.g., heart failure, hypokalemia, family history of Long QT Syndrome;
- Use of concomitant medications that prolong the QT/QTc interval (see exclusion criterion 19 and disallowed medications;
- Pathological Q waves (defined as >40ms or depth >0.4-0.5mV);
- ECG evidence of ventricular pre-excitation;
- ECG evidence of complete or incomplete left bundle branch block or right bundle branch block;
- ECG evidence of second or third degree heart block;
- Intraventricular conduction delay with QRS duration >120ms;
- Bradycardia as defined by sinus rate <50bpm.
- Females who are pregnant, breast-feeding, or planning to conceive a child within 6 months of cessation of treatment. Males planning to conceive a child within twelve weeks of cessation of treatment.
- Diabetes Mellitus requiring insulin.
- History of lens opacity.
- For males, any history of a clinically significant abnormality in the reproductive system.
- Specific Treatments
- Previously received treatment with Clofazimine, TMC207 or PA-824.
- Treatment received with any drug active against MTB within the 3 months prior to Visit 1 (e.g. isoniazid, ethambutol, amikacin, cycloserine, fluoroquinolones, rifabutin, rifampicin, streptomycin, kanamycin, para-aminosalicylic acid, rifapentine, pyrazinamide, thioacetazone, capreomycin, thioamides, metronidazole).
- Any diseases or conditions in which the use of the standard TB drugs or any of their components is contra-indicated, including but not limited to allergy to any TB drug, their component or to the IMP.
- Concomitant use of any drug known to prolong QTc interval (including amiodarone, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, cyclobenzaprine, disopyramide dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, quinidine, sotalol, sparfloxacin, thioridazine).
- Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes (such as quinidine, tyramine, ketoconazole, testosterone, quinine, gestodene, metyrapone, phenelzine, doxorubicin, troleandomycin, cyclobenzaprine, erythromycin, cocaine, furafylline, cimetidine, dextromethorphan). Exceptions may be made for participants that have received 3 days or less of one of these drugs or substances, if there has been a wash-out period before administration of IMP equivalent to at least 5 half-lives of that drug or substance.
- Use of any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine) within 30 days prior to dosing. Exceptions for opiate and pain killer use for cough or underlying disease may be made at investigator discretion.
- Based on Laboratory Abnormalities
- Participants with the following toxicities at screening as defined by the enhanced Division of Microbiology and Infectious Disease (DMID) adult toxicity table (November 2007):
- creatinine grade 2 or greater (>1.5 times upper limit of normal [ULN]);
- lipase grade 3 or greater (>2.0 x ULN);
- hemoglobin grade 4 (<6.5 g/dL);
- platelets grade 2 or greater (under 50x109 cells/L);
- serum potassium grade 2 or greater (<3.5 mEq/L);
- aspartate aminotransferase (AST) grade 3 (≥3.0 x ULN) to be excluded;
- alanine aminotransferase (ALT) grade 3 (≥3.0 x ULN) to be excluded;
- alkaline phosphatase (ALP) grade 4 (>8.0 x ULN) to be excluded, grade 3 (≥3.0 x ULN) must be discussed with the sponsor Medical Monitor;
- total bilirubin grade 3 or greater (>2.0 x ULN, or >1.50 x ULN when accompanied by any increase in other liver function test) to be excluded, grade 2 (>1.50 x ULN, or >1.25 x ULN when accompanied by any increase in other liver function test) must be discussed with the sponsor Medical Monitor.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Centre for Tuberculosis Research Innovation, UCT Lung Institute
Cape Town
Task Applied Science, Karl Bremer Hospita
Cape Town
About this study
Official title: A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of the Following: TMC207 Plus PA-824 Plus Pyrazinamide Plus Clofazimine, TMC207 Plus PA-824 Plus Pyrazinamide, TMC207 Plus PA-824 Plus Clofazimine Alone, TMC207 Plus Pyrazinamide Plus Clofazimine, Pyrazinamide Alone, and Clofazimine Alone; in Adult Patients With Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis.
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824 plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus Clofazimine, Pyrazinamide alone, Clofazimine alone, and standard first line TB treatment as per South African TB Guidelines (Rifafour e-275) as determined by the rate of change of log CFU per ml sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- TMC207 (J), PA-824 (PA), pyrazinamide (Z), clofazimine (C), Rifafour
- Keywords
- Tuberculosis, EBA, PA824, pretomanid, TMC207
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC207 (J)Drug
TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14
PA-824 (PA)Drug
PA-824 200mg Days 1-14
pyrazinamide (Z)Drug
1500mg Days 1-14 Dosed by Weight
clofazimine (C)Drug
clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14
RifafourDrug
Rifafour e-275 mg dosed by weight
| Study group | Role | What they receive |
|---|---|---|
| TMC207, PA-824, pyrazinamide and clofazimine (J-PA-Z-C) | Experimental | TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus pyrazinamide 1500mg Days 1-14 plus clofazimine 300mg Days 1-3 and Clofazamine 100mg Days 4-14 Receives: Drug: TMC207 (J); Drug: PA-824 (PA); Drug: pyrazinamide (Z); Drug: clofazimine (C) |
| TMC207, PA-824 and pyrazinamide (J-PA-Z) | Experimental | TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus pyrazinamide 1500mg Days 1-14 Receives: Drug: TMC207 (J); Drug: PA-824 (PA); Drug: pyrazinamide (Z) |
| TMC207, PA-824 and clofazimine (J-PA-C) | Experimental | TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14 Receives: Drug: TMC207 (J); Drug: PA-824 (PA); Drug: clofazimine (C) |
| TMC207, pyrazinamide and clofazimine (J-Z-C) | Experimental | TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus pyrazinamide 1500mg Days 1-14 plus clofazimine 300mg Days 1-3 and Clofazimine 100mg Days 4-14 Receives: Drug: TMC207 (J); Drug: pyrazinamide (Z); Drug: clofazimine (C) |
| pyrazinamide (Z) | Experimental | pyrazinamide 1500mg Days 1-14 Receives: Drug: pyrazinamide (Z) |
| clofazimine (C) | Experimental | Clofazimine 300mg Days 1-3 and Clofazimine 100mg Days 4-14 Receives: Drug: clofazimine (C) |
| Rifafour | Active comparator | Rifafour e-275 mg dosed by weight Receives: Drug: Rifafour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).
Measured: 14 consecutive days of treatment
Secondary outcomes (5)
EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 0-2)
Measured: Days 0-2
EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 7-14)
Measured: Day 7-14
EBA Expressed as the Daily Percentage Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)
Measured: Days 0-14
EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Day 0-2)
Measured: Day 0-2
EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Days 7-14)
Measured: Days 7-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Alliance for TB Drug Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Diacon, MD, Principal investigator, Karl Bremer Hospital, Cape Town South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691534
- Sponsor's protocol ID
- NC-003-(C-J-Pa-Z)
- Acronym
- NC-003
- Status last verified
- Aug 2016
- First submitted
- 20 Sep 2012
- Last updated
- 13 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Diacon AH, Dawson R, von Groote-Bidlingmaier F, Symons G, Venter A, Donald PR, van Niekerk C, Everitt D, Hutchings J, Burger DA, Schall R, Mendel CM. Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline. Am J Respir Crit Care Med. 2015 Apr 15;191(8):943-53. doi: 10.1164/rccm.201410-1801OC.
PubMed 25622149
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of the Following: TMC207 Plus PA-824 Plus Pyrazinamide Plus Clofazimine, TMC207 Plus PA-824 Plus Pyrazinamide, TMC207 Plus PA-824 Plus Clofazimine Alone, TMC207 Plus Pyrazinamide Plus Clofazimine, Pyrazinamide Alone, and Clofazimine Alone; in Adult Patients With Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis.
- ClinicalTrials.gov ID
- NCT01691534
- Acronym / sponsor ID
- NC-003 / NC-003-(C-J-Pa-Z)
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Tuberculosis, EBA, PA824, pretomanid, TMC207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Global Alliance for TB Drug DevelopmentUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Posted 13 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824 plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus Clofazimine, Pyrazinamide alone, Clofazimine alone, and standard first line TB treatment as per South African TB Guidelines (Rifafour e-275) as determined by the rate of change of log CFU per ml sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| TMC207, PA-824, pyrazinamide and clofazimine (J-PA-Z-C) | Experimental | Drug: TMC207 (J), Drug: PA-824 (PA), Drug: pyrazinamide (Z), Drug: clofazimine (C)TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus pyrazinamide 1500mg Days 1-14 plus clofazimine 300mg Days 1-3 and Clofazamine 100mg Days 4-14 |
| TMC207, PA-824 and pyrazinamide (J-PA-Z) | Experimental | Drug: TMC207 (J), Drug: PA-824 (PA), Drug: pyrazinamide (Z)TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus pyrazinamide 1500mg Days 1-14 |
| TMC207, PA-824 and clofazimine (J-PA-C) | Experimental | Drug: TMC207 (J), Drug: PA-824 (PA), Drug: clofazimine (C)TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus PA-824 200mg Days 1-14 plus clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14 |
| TMC207, pyrazinamide and clofazimine (J-Z-C) | Experimental | Drug: TMC207 (J), Drug: pyrazinamide (Z), Drug: clofazimine (C)TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 plus pyrazinamide 1500mg Days 1-14 plus clofazimine 300mg Days 1-3 and Clofazimine 100mg Days 4-14 |
| pyrazinamide (Z) | Experimental | Drug: pyrazinamide (Z)pyrazinamide 1500mg Days 1-14 |
| clofazimine (C) | Experimental | Drug: clofazimine (C)Clofazimine 300mg Days 1-3 and Clofazimine 100mg Days 4-14 |
| Rifafour | Active comparator | Drug: RifafourRifafour e-275 mg dosed by weight |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 1. Provide written, informed consent prior to all trial-related procedures including HIV testing.
- 2. Male or female, aged between 18 and 65 years inclusive.
- 3. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
- 4. Newly diagnosed, previously untreated, sputum smear-positive pulmonary TB.
- 5. A chest X-ray picture which in the opinion of the Investigator is compatible with TB.
Key exclusion criteria (46 listed)
- Evidence of clinically significant (as judged by the investigator), metabolic, gastrointestinal, cardiovascular, musculoskeletal, ophthalmological, pulmonary, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied) including malaria.
- Poor general condition where any delay in treatment cannot be tolerated per discretion of the Investigator.
- A history of previous TB.
- Clinically significant evidence of extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator.
- History of allergy to the IMP or related substances.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMC207 (J)TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14 | Drug | TMC207, PA-824 and clofazimine (J-PA-C), TMC207, PA-824 and pyrazinamide (J-PA-Z), TMC207, PA-824, pyrazinamide and clofazimine (J-PA-Z-C), TMC207, pyrazinamide and clofazimine (J-Z-C) |
| PA-824 (PA)PA-824 200mg Days 1-14 | Drug | TMC207, PA-824 and clofazimine (J-PA-C), TMC207, PA-824 and pyrazinamide (J-PA-Z), TMC207, PA-824, pyrazinamide and clofazimine (J-PA-Z-C) |
| pyrazinamide (Z)1500mg Days 1-14 Dosed by Weight | Drug | TMC207, PA-824 and pyrazinamide (J-PA-Z), TMC207, PA-824, pyrazinamide and clofazimine (J-PA-Z-C), TMC207, pyrazinamide and clofazimine (J-Z-C), pyrazinamide (Z) |
| clofazimine (C)clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14 | Drug | TMC207, PA-824 and clofazimine (J-PA-C), TMC207, PA-824, pyrazinamide and clofazimine (J-PA-Z-C), TMC207, pyrazinamide and clofazimine (J-Z-C), clofazimine (C) |
| RifafourRifafour e-275 mg dosed by weight | Drug | Rifafour |
Primary outcome
Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).
Time frame: 14 consecutive days of treatment
5 secondary outcomes
EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 0-2)
Time frame: Days 0-2
EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 7-14)
Time frame: Day 7-14
EBA Expressed as the Daily Percentage Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)
Time frame: Days 0-14
EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Day 0-2)
Time frame: Day 0-2
EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Days 7-14)
Time frame: Days 7-14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25622149Diacon AH, Dawson R, von Groote-Bidlingmaier F, Symons G, Venter A, Donald PR, van Niekerk C, Everitt D, Hutchings J, Burger DA, Schall R, Mendel CM. Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline. Am J Respir Crit Care Med. 2015 Apr 15;191(8):943-53. doi: 10.1164/rccm.201410-1801OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Diacon, MD principal investigator
Karl Bremer Hospital, Cape Town South Africa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMC207 (J), PA-824 (PA) and pyrazinamide (Z) in people with Pulmonary Tuberculosis, run by Global Alliance for TB Drug Development at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14). (time frame: 14 consecutive days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01691534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.