Pulmonary TuberculosisPhase 2NCT00567840
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
A Phase 2 study testing PA-824 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 PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- PA-824
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Aug 2007to Dec 2007
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- informed consent
- M/F 18-64 yo
- newly diagnosed pulmonary TB
- sputum positive
- adequate contraception
Who cannot join
- poor health
- rifampicin resistance
- treatment with other anti TB agents in last 3 mos.
- extrapulmonary TB
- COPD
- neuropathy
Show all 14Show fewer
- ECG wih QRS prolongation ove 120 msec
- CV disorder
- diabetes requiring insulin
- Metabolic disease
- drug/alcohol abuse
- pregnancy
- use of substances that are strong inhibitors/inducers of CYP450
- use of ARV
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Tiervlei Trials Center, Stellenbosch University
Cape Town, Cape Province, 8000
University of Cape Town Lung Institute
Cape Town, Cape Province
About this study
Official title: A Phase IIa Trial to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of 14 Days' Treatment With Four Oral Doses of PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- PA-824
- Keywords
- Early Bactericidal Activity, EBA, pulmonary tuberculosis, PA-824, Pretomanid, CL-007
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA-824Drug
Also called Rifafour e-275
200 mg, 600 mg, 100 mg, 1200 mg qd
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PA-824 200 mg/qd Receives: Drug: PA-824 |
| 2 | Experimental | PA-824 600 mg/qd Receives: Drug: PA-824 |
| 3 | Experimental | PA-824 1000 mg/qd Receives: Drug: PA-824 |
| 4 | Experimental | PA-824 1200 mg/qd Receives: Drug: PA-824 |
| 5 | Active comparator | Rifafour e-275 mg Receives: Drug: PA-824 |
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: Day 0 and Day 14
Secondary outcomes (5)
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 0-2).
Measured: Day 0 and Day 2
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 2-14).
Measured: Day 2 and Day 14
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)
Measured: Day 0 and Day 14
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2)
Measured: Day 0 and Day 2
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified]
Measured: Day 2 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionDec 2007
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Alliance for TB Drug Development
- Sponsor type
- University, hospital or other
- Investigators
- Rodney Dawson, MD, Principal investigator, UCT Lung InstituteAndreas Diacon, MD, Principal investigator, Tiervlei Trial Center, Stelennbosch University, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567840
- Sponsor's protocol ID
- PA-824-CL-007
- Status last verified
- Jan 2017
- First submitted
- 4 Dec 2007
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Trial to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of 14 Days' Treatment With Four Oral Doses of PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT00567840
- Acronym / sponsor ID
- PA-824-CL-007
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Early Bactericidal Activity, EBA, pulmonary tuberculosis, PA-824, Pretomanid, CL-007
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Global Alliance for TB Drug DevelopmentUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Posted 4 Apr 2017
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 PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PA-824PA-824 200 mg/qd |
| 2 | Experimental | Drug: PA-824PA-824 600 mg/qd |
| 3 | Experimental | Drug: PA-824PA-824 1000 mg/qd |
| 4 | Experimental | Drug: PA-824PA-824 1200 mg/qd |
| 5 | Active comparator | Drug: PA-824Rifafour e-275 mg |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- informed consent
- M/F 18-64 yo
- newly diagnosed pulmonary TB
- sputum positive
- adequate contraception
Key exclusion criteria (14 listed)
- poor health
- rifampicin resistance
- treatment with other anti TB agents in last 3 mos.
- extrapulmonary TB
- COPD
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 |
|---|---|---|
| PA-824Also: Rifafour e-275200 mg, 600 mg, 100 mg, 1200 mg qd | Drug | 1, 2, 3, 4, 5 |
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: Day 0 and Day 14
5 secondary outcomes
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 0-2).
Time frame: Day 0 and Day 2
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 2-14).
Time frame: Day 2 and Day 14
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)
Time frame: Day 0 and Day 14
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2)
Time frame: Day 0 and Day 2
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified]
Time frame: Day 2 and Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Rodney Dawson, MD principal investigator
UCT Lung Institute
Andreas Diacon, MD principal investigator
Tiervlei Trial Center, Stelennbosch University, 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 PA-824 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 5 inclusion and 14 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 May 2017. 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 4 Apr 2017). 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: Day 0 and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2017.