TuberculosisPhase 2NCT01516203
Phase 2a EBA Trial of AZD5847
A Phase 2 study testing AZD5847 and Ethambutol, isoniazid, pyrazinamide, rifampin in people with Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in South Africa.
Trial summary
The purpose of this study is to assess the early bacterial activity (EBA) from day 0 to day 14 of Astra Zeneca Drug (AZD5847) at four different doses and schedules (500 mg once daily, 500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with newly-diagnosed sputum smear positive pulmonary TB. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- AZD5847 and Ethambutol, isoniazid, pyrazinamide, rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Africa
- Study dates
- 5 Dec 2012to 24 Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Adults, male or female, age 18 to 65 years - Post-menopausal women under the age of 65 years will be included in the study. Women of childbearing potential must be using or agree to use an adequate method of birth control through the end of study follow up. These methods include: total sexual abstinence; a single male partner who has been vasectomized combined with use of a condom; a combination of two effective birth control methods from the following list: a. an intrauterine device plus a condom; b. a tubal ligation (tubes tied) plus a condom; c. Depo-provera injections plus a condom; d. Intravaginal ring plus a condom - Newly diagnosed sputum smear-positive pulmonary tuberculosis as confirmed by at least one sputum AFB + smear (at least grade 1+ using the WHO/IUATLD grading scale) - Willing and able to provide informed consent - Hemoglobin >/= 8 gm/dL - Serum creatinine < 2 mg/dL (<176.8 umol/L) - Serum AST < 3.0 times the upper limit of normal for the testing laboratory and total bilirubin < 1.3 mg/dL - Random blood glucose < 150 mg/dL (< 8.32 mmol/L) - If HIV-positive, not currently on ART, CD4 count> 350 muL^-1 and/or no need to start ART in the opinion of the local investigator - Cough productive of at least 10 ml (two teaspoons) of sputum daily per patient report over the week prior to enrollment. - Chest radiograph compatible with pulmonary TB. - Negative sputum Xpert™ MTB/RIF test for rifampin resistance. - Negative urine pregnancy test
Who cannot join
- HIV infection with CD4 count of </=350muL^-1 and/or the need to start ART in the opinion of the local investigator. - Weight less than 40 kg or greater than 90 kg - Presence of hemoptysis. Subjects who cough up frank blood (more than blood streaked sputum) will not be eligible for enrollment. - Subjects with rifampin resistance as determined by the Xpert test as screening. - Pregnant or breastfeeding women - Presence of pneumothorax on pretreatment chest radiograph - Clinical suspicion of disseminated tuberculosis or tuberculous meningitis or pulmonary TB requiring immediate start of standard chemotherapy in the opinion of the local investigator - Presence of serious underlying medical illness, such as liver failure, renal failure,any diabetes mellitus, chronic alcoholism (> 3 alcoholic drinks per day), decompensated heart failure, cardiac arrhythmias, hematologic malignancy or subjects receiving myelosuppressive chemotherapy. - Allergy or contraindication to study drugs - Prior treatment for TB with antituberculous medications (isoniazid, rifampin, pyrazinamide, ethambutol or streptomycin or those treated with other antibiotics with known activity against MTB during the preceding 6 months (for example aminoglycosides, fluoroquinolones, carbapenems and linezolid) - Subjects taking monoamine oxidase (MAO) inhibitors or selective serotonin release inhibitor (SSRI) medications - Total white blood cell count less than 3000/mm^3 - Platelet count less than 150,000/mm^3 - Subjects with QTcF> 450 msec, QTcF < 340 msec, and/or family history of long QT syndrome - Subjects unlikely in the opinion of the local investigator to be able to comply with the requirements of the study protocol - Subjects whose urine tests positive for INH metabolites, indicating they are already receiving anti-TB treatment. - History of tuberculosis less than 5 years ago, history of more than one episode of tuberculosis, history of drug resistant tuberculosis, or household contact with an individual who has confirmed drug-resistant tuberculosis. - Known arrhythmias or other cardiac conditions - Active severe dermatologic disease (Grade 3 or Grade 4 per DMID Adult Toxicity Table) - Immunosuppressive conditions or receiving immunosuppressive medications - A history of optic neuritis. - Subjects on antiretroviral therapy for HIV (including AZT, 3TC, FTC, D4T, ddI, ddC, tenofovir, abacavir, nevirapine, efavirenz, ritonavir, lopinavir, atazanavir, saquinavir, darunavir, indinavir, raltegravir) - Subjects taking drugs capable of prolonging the QTc interval, such as type Ia and III anti-arrhythmics - Random urine toxicology screen positive for cocaine or methamphetamines.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Task Clinical Research Centre
Ekurhuleni, Gauteng, 7530
About this study
Official title: Randomized, Open Label, Multiple Dose Phase 2a Study of the Early Bactericidal Activity of AZD5847 in Adults With Pulmonary Tuberculosis
The purpose of this study is to assess the early bacterial activity (EBA) from day 0 to day 14 of Astra Zeneca Drug (AZD5847) at four different doses and schedules (500 mg once daily, 500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with newly-diagnosed sputum smear positive pulmonary TB. A total of 75 subjects will be enrolled, with 15 randomized to each AZD5847 study arm or standard treatment with Rifafour. Duration of drug treatment is 14 days.
Read the detailed description
This is a study of early bactericidal activity (EBA) in treatment-naïve patients with active pulmonary tuberculosis. This prospective, randomized, open-label study that will compare the effect of monotherapy with each of four dose levels of AZD5847 to that of an active control (Rifafour administered orally once daily) on the concentration of Mycobacterium tuberculosis (M. tb) in expectorated sputum (colony-forming units per mL of sputum). Daily quantitative sputum cultures will be performed during treatment and analyzed by investigators who will be blinded to the assigned treatment. The duration of therapy will be 14 days in order to support an assessment of early bactericidal activity (days 0-2) and sterilizing activity (days 3-14). Because of the risk of emergence of drug resistance in TB patients treated with a single active drug, regulatory and ethical requirements restrict monotherapy to a maximum duration of 14 days (EMEA Draft TB Guidance 2008). The study will utilize a standard design and will thus support comparison with other marketed and investigational antimycobacterial agents (Donald and Diacon 2008). The primary aim of the study is to assess the EBA 0-14 of AZD5847 at four different doses and schedules (500 mg once daily, 500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with newly-diagnosed sputum smear positive pulmonary TB. The secondary aim is to assess the EBA 0-2 and EBA 2-14 of AZD5847 at the above doses.
- Conditions
- Tuberculosis
- Being tested
- AZD5847, Ethambutol, isoniazid, pyrazinamide, rifampin
- Keywords
- AZD5847, dose-ranging, Mycobacterium tuberculosis, Rifafour, tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5847Drug
Eligible subjects will be randomly assigned to receive monotherapy with one of four doses of oral AZD5847 for 14 days: 500 mg orally once daily, 500 mg orally twice daily, 1200 mg orally once daily, or 800 mg orally twice daily.
Ethambutol, isoniazid, pyrazinamide, rifampinDrug
Eligible subjects will be randomly assigned to receive treatment with standard 4 drug anti-tuberculosis regimen: Rifafour e-275 mg tablets (75 mg isoniazid/150 mg Rifampin/275 mg Ethambutol/400 mg Pyrazinamide) orally, dosed by body weight for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | AZD5847 500 mg orally once daily given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis Receives: Drug: AZD5847 |
| Arm 2 | Experimental | AZD5847 500 mg orally twice daily given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis Receives: Drug: AZD5847 |
| Arm 3 | Experimental | AZD5847 1200 mg orally once daily given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis Receives: Drug: AZD5847 |
| Arm 4 | Experimental | AZD5847 800 mg orally twice daily given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis Receives: Drug: AZD5847 |
| Arm 5 | Active comparator | Rifafour e-275 mg tablets given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis Receives: Drug: Ethambutol, isoniazid, pyrazinamide, rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Bactericidal Activity: Rate of change in sputum colony forming unit (CFU) counts (bactericidal activity) during the entire 14 days of study drug administration (EBA0-14)
Measured: Day 0 to Day 14
Secondary outcomes (9)
Adverse event collection: Complete blood count, coagulation panels, liver function tests, Creatine phosphokinase, urinalysis and 12-lead electrocardiograms as well as unsolicited events (adverse events, serious adverse events).
Measured: Day 0 to Day 28
Change in Mycobacterium tuberculosis (MTB) mRNA in sputum by RT-PCR for fbpB, hspX, icl1, rrnA-p1 and other specific mycobacterial mRNA targets of interest over the periods (baseline and Days 2, 4, 8, 14)
Measured: Baseline and Days 2, 4, 8, 14
Change in urine, sputum, and serum metabolomic biomarkers over the periods (baseline and Days 8, 14)
Measured: Baseline and Days 8, 14
Pharmacokinetic and pharmacodynamic parameters Tmax, Cmax, half life, AUC, AUC/MIC, Cmax, Cmax/MIC, time > MIC using non-compartmental analysis, compartmental and population models
Measured: Day 1, 3, 5, 10 and 14
Rate of change in sputum CFU counts (bactericidal activity) during the first 2 days of study drug administration (traditional EBA; EBA0-2)
Measured: Day 0 to Day 2
Rate of change in sputum CFU counts (bactericidal activity) during the first 2 to 14 days of study drug administration (traditional EBA; EBA2-14)
Measured: Day 2 to Day 14
The change in time after inoculation until culture detection (time to detection; TTD) in MGIT enriched liquid culture media over the period Day 0 to Day 2
Measured: Day 0 to Day 2
The change in time after inoculation until culture detection (time to detection; TTD) in MGIT enriched liquid culture media over the period Day 2 to Day 14
Measured: Day 2 to Day 14
The change in time after inoculation until culture detection (time to detection; TTD) in Mycobacterial Growth Indicator Tube (MGIT) enriched liquid culture media over the period Day 0 to Day 14
Measured: Day 0 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study start5 Dec 2012
- Primary completion12 Dec 2013
- Study completion24 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516203
- Sponsor's protocol ID
- 11-0006
- Status last verified
- 19 Mar 2014
- First submitted
- 19 Jan 2012
- Last updated
- 15 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Alsultan A, Furin JJ, Du Bois J, van Brakel E, Chheng P, Venter A, Thiel B, Debanne SA, Boom WH, Diacon AH, Johnson JL, Peloquin CA. Population Pharmacokinetics of AZD-5847 in Adults with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e01066-17. doi: 10.1128/AAC.01066-17. Print 2017 Oct.
PubMed 28739794Furin JJ, Du Bois J, van Brakel E, Chheng P, Venter A, Peloquin CA, Alsultan A, Thiel BA, Debanne SM, Boom WH, Diacon AH, Johnson JL. Early Bactericidal Activity of AZD5847 in Patients with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6591-6599. doi: 10.1128/AAC.01163-16. Print 2016 Nov.
PubMed 27550361
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Multiple Dose Phase 2a Study of the Early Bactericidal Activity of AZD5847 in Adults With Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT01516203
- Acronym / sponsor ID
- 11-0006
- Conditions
- Tuberculosis
- Keywords
- AZD5847, dose-ranging, Mycobacterium tuberculosis, Rifafour, tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 5 Dec 2012 (actual)
- Primary completion
- 12 Dec 2013 (actual)
- Study completion
- 24 Dec 2013 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the early bacterial activity (EBA) from day 0 to day 14 of Astra Zeneca Drug (AZD5847) at four different doses and schedules (500 mg once daily, 500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with newly-diagnosed sputum smear positive pulmonary TB. A total of 75 subjects will be enrolled, with 15 randomized to each AZD5847 study arm or standard treatment with Rifafour. Duration of drug treatment is 14 days.
Detailed description
This is a study of early bactericidal activity (EBA) in treatment-naïve patients with active pulmonary tuberculosis. This prospective, randomized, open-label study that will compare the effect of monotherapy with each of four dose levels of AZD5847 to that of an active control (Rifafour administered orally once daily) on the concentration of Mycobacterium tuberculosis (M. tb) in expectorated sputum (colony-forming units per mL of sputum). Daily quantitative sputum cultures will be performed during treatment and analyzed by investigators who will be blinded to the assigned treatment. The duration of therapy will be 14 days in order to support an assessment of early bactericidal activity (days 0-2) and sterilizing activity (days 3-14). Because of the risk of emergence of drug resistance in TB patients treated with a single active drug, regulatory and ethical requirements restrict monotherapy to a maximum duration of 14 days (EMEA Draft TB Guidance 2008). The study will utilize a standard design and will thus support comparison with other marketed and investigational antimycobacterial agents (Donald and Diacon 2008). The primary aim of the study is to assess the EBA 0-14 of AZD5847 at four different doses and schedules (500 mg once daily, 500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with newly-diagnosed sputum smear positive pulmonary TB. The secondary aim is to assess the EBA 0-2 and EBA 2-14 of AZD5847 at the above doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AZD5847AZD5847 500 mg orally once daily given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis |
| Arm 2 | Experimental | Drug: AZD5847AZD5847 500 mg orally twice daily given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis |
| Arm 3 | Experimental | Drug: AZD5847AZD5847 1200 mg orally once daily given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis |
| Arm 4 | Experimental | Drug: AZD5847AZD5847 800 mg orally twice daily given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis |
| Arm 5 | Active comparator | Drug: Ethambutol, isoniazid, pyrazinamide, rifampinRifafour e-275 mg tablets given to 15 male and female subjects aged 18 to 65 years with newly diagnosed sputum smear positive pulmonary tuberculosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults, male or female, age 18 to 65 years - Post-menopausal women under the age of 65 years will be included in the study. Women of childbearing potential must be using or agree to use an adequate method of birth control through the end of study follow up. These methods include: total sexual abstinence; a single male partner who has been vasectomized combined with use of a condom; a combination of two effective birth control methods from the following list: a. an intrauterine device plus a condom; b. a tubal ligation (tubes tied) plus a condom; c. Depo-provera injections plus a condom; d. Intravaginal ring plus a condom - Newly diagnosed sputum smear-positive pulmonary tuberculosis as confirmed by at least one sputum AFB + smear (at least grade 1+ using the WHO/IUATLD grading scale) - Willing and able to provide informed consent - Hemoglobin >/= 8 gm/dL - Serum creatinine < 2 mg/dL (<176.8 umol/L) - Serum AST < 3.0 times the upper limit of normal for the testing laboratory and total bilirubin < 1.3 mg/dL - Random blood glucose < 150 mg/dL (< 8.32 mmol/L) - If HIV-positive, not currently on ART, CD4 count> 350 muL^-1 and/or no need to start ART in the opinion of the local investigator - Cough productive of at least 10 ml (two teaspoons) of sputum daily per patient report over the week prior to enrollment. - Chest radiograph compatible with pulmonary TB. - Negative sputum Xpert™ MTB/RIF test for rifampin resistance. - Negative urine pregnancy test
Key exclusion criteria (1 listed)
- HIV infection with CD4 count of </=350muL^-1 and/or the need to start ART in the opinion of the local investigator. - Weight less than 40 kg or greater than 90 kg - Presence of hemoptysis. Subjects who cough up frank blood (more than blood streaked sputum) will not be eligible for enrollment. - Subjects with rifampin resistance as determined by the Xpert test as screening. - Pregnant or breastfeeding women - Presence of pneumothorax on pretreatment chest radiograph - Clinical suspicion of disseminated tuberculosis or tuberculous meningitis or pulmonary TB requiring immediate start of standard chemotherapy in the opinion of the local investigator - Presence of serious underlying medical illness, such as liver failure, renal failure,any diabetes mellitus, chronic alcoholism (> 3 alcoholic drinks per day), decompensated heart failure, cardiac arrhythmias, hematologic malignancy or subjects receiving myelosuppressive chemotherapy. - Allergy or contraindication to study drugs - Prior treatment for TB with antituberculous medications (isoniazid, rifampin, pyrazinamide, ethambutol or streptomycin or those treated with other antibiotics with known activity against MTB during the preceding 6 months (for example aminoglycosides, fluoroquinolones, carbapenems and linezolid) - Subjects taking monoamine oxidase (MAO) inhibitors or selective serotonin release inhibitor (SSRI) medications - Total white blood cell count less than 3000/mm^3 - Platelet count less than 150,000/mm^3 - Subjects with QTcF> 450 msec, QTcF < 340 msec, and/or family history of long QT syndrome - Subjects unlikely in the opinion of the local investigator to be able to comply with the requirements of the study protocol - Subjects whose urine tests positive for INH metabolites, indicating they are already receiving anti-TB treatment. - History of tuberculosis less than 5 years ago, history of more than one episode of tuberculosis, history of drug resistant tuberculosis, or household contact with an individual who has confirmed drug-resistant tuberculosis. - Known arrhythmias or other cardiac conditions - Active severe dermatologic disease (Grade 3 or Grade 4 per DMID Adult Toxicity Table) - Immunosuppressive conditions or receiving immunosuppressive medications - A history of optic neuritis. - Subjects on antiretroviral therapy for HIV (including AZT, 3TC, FTC, D4T, ddI, ddC, tenofovir, abacavir, nevirapine, efavirenz, ritonavir, lopinavir, atazanavir, saquinavir, darunavir, indinavir, raltegravir) - Subjects taking drugs capable of prolonging the QTc interval, such as type Ia and III anti-arrhythmics - Random urine toxicology screen positive for cocaine or methamphetamines.
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 |
|---|---|---|
| AZD5847Eligible subjects will be randomly assigned to receive monotherapy with one of four doses of oral AZD5847 for 14 days: 500 mg orally once daily, 500 mg orally twice daily, 1200 mg orally once daily, or 800 mg orally twice daily. | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| Ethambutol, isoniazid, pyrazinamide, rifampinEligible subjects will be randomly assigned to receive treatment with standard 4 drug anti-tuberculosis regimen: Rifafour e-275 mg tablets (75 mg isoniazid/150 mg Rifampin/275 mg Ethambutol/400 mg Pyrazinamide) orally, dosed by body weight for 14 days. | Drug | Arm 5 |
Primary outcome
Early Bactericidal Activity: Rate of change in sputum colony forming unit (CFU) counts (bactericidal activity) during the entire 14 days of study drug administration (EBA0-14)
Time frame: Day 0 to Day 14
9 secondary outcomes
Adverse event collection: Complete blood count, coagulation panels, liver function tests, Creatine phosphokinase, urinalysis and 12-lead electrocardiograms as well as unsolicited events (adverse events, serious adverse events).
Time frame: Day 0 to Day 28
Change in Mycobacterium tuberculosis (MTB) mRNA in sputum by RT-PCR for fbpB, hspX, icl1, rrnA-p1 and other specific mycobacterial mRNA targets of interest over the periods (baseline and Days 2, 4, 8, 14)
Time frame: Baseline and Days 2, 4, 8, 14
Change in urine, sputum, and serum metabolomic biomarkers over the periods (baseline and Days 8, 14)
Time frame: Baseline and Days 8, 14
Pharmacokinetic and pharmacodynamic parameters Tmax, Cmax, half life, AUC, AUC/MIC, Cmax, Cmax/MIC, time > MIC using non-compartmental analysis, compartmental and population models
Time frame: Day 1, 3, 5, 10 and 14
Rate of change in sputum CFU counts (bactericidal activity) during the first 2 days of study drug administration (traditional EBA; EBA0-2)
Time frame: Day 0 to Day 2
Rate of change in sputum CFU counts (bactericidal activity) during the first 2 to 14 days of study drug administration (traditional EBA; EBA2-14)
Time frame: Day 2 to Day 14
The change in time after inoculation until culture detection (time to detection; TTD) in MGIT enriched liquid culture media over the period Day 0 to Day 2
Time frame: Day 0 to Day 2
The change in time after inoculation until culture detection (time to detection; TTD) in MGIT enriched liquid culture media over the period Day 2 to Day 14
Time frame: Day 2 to Day 14
The change in time after inoculation until culture detection (time to detection; TTD) in Mycobacterial Growth Indicator Tube (MGIT) enriched liquid culture media over the period Day 0 to Day 14
Time frame: Day 0 to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Results publication: PubMed 28739794Alsultan A, Furin JJ, Du Bois J, van Brakel E, Chheng P, Venter A, Thiel B, Debanne SA, Boom WH, Diacon AH, Johnson JL, Peloquin CA. Population Pharmacokinetics of AZD-5847 in Adults with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e01066-17. doi: 10.1128/AAC.01066-17. Print 2017 Oct.
- Results publication: PubMed 27550361Furin JJ, Du Bois J, van Brakel E, Chheng P, Venter A, Peloquin CA, Alsultan A, Thiel BA, Debanne SM, Boom WH, Diacon AH, Johnson JL. Early Bactericidal Activity of AZD5847 in Patients with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6591-6599. doi: 10.1128/AAC.01163-16. Print 2016 Nov.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD5847 and Ethambutol, isoniazid, pyrazinamide, rifampin in people with Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 1 inclusion and 1 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 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Rate of change in sputum colony forming unit (CFU) counts (bactericidal activity) during the entire 14 days of study drug administration (EBA0-14) (time frame: Day 0 to Day 14). 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 NCT01516203, which also lists 2 linked publications.
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 15 Oct 2018.