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PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis

Primary Purpose

Pulmonary Tuberculosis

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
PA-824
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 focused on measuring Early Bactericidal Activity, EBA, pulmonary tuberculosis, PA-824, Pretomanid, CL-007

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • informed consent
  • M/F 18-64 yo
  • newly diagnosed pulmonary TB
  • sputum positive
  • adequate contraception

Exclusion Criteria:

  • poor health
  • rifampicin resistance
  • treatment with other anti TB agents in last 3 mos.
  • extrapulmonary TB
  • COPD
  • neuropathy
  • 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

Sites / Locations

  • Tiervlei Trials Center, Stellenbosch University
  • University of Cape Town Lung Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

PA-824 200 mg/qd

PA-824 600 mg/qd

PA-824 1000 mg/qd

PA-824 1200 mg/qd

Rifafour e-275 mg

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2)
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified]

Full Information

First Posted
December 4, 2007
Last Updated
April 10, 2017
Sponsor
Global Alliance for TB Drug Development
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1. Study Identification

Unique Protocol Identification Number
NCT00567840
Brief Title
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Global Alliance for TB Drug Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis
Keywords
Early Bactericidal Activity, EBA, pulmonary tuberculosis, PA-824, Pretomanid, CL-007

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PA-824 200 mg/qd
Arm Title
2
Arm Type
Experimental
Arm Description
PA-824 600 mg/qd
Arm Title
3
Arm Type
Experimental
Arm Description
PA-824 1000 mg/qd
Arm Title
4
Arm Type
Experimental
Arm Description
PA-824 1200 mg/qd
Arm Title
5
Arm Type
Active Comparator
Arm Description
Rifafour e-275 mg
Intervention Type
Drug
Intervention Name(s)
PA-824
Other Intervention Name(s)
Rifafour e-275
Intervention Description
200 mg, 600 mg, 100 mg, 1200 mg qd
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: informed consent M/F 18-64 yo newly diagnosed pulmonary TB sputum positive adequate contraception Exclusion Criteria: poor health rifampicin resistance treatment with other anti TB agents in last 3 mos. extrapulmonary TB COPD neuropathy 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney Dawson, MD
Organizational Affiliation
UCT Lung Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Diacon, MD
Organizational Affiliation
Tiervlei Trial Center, Stelennbosch University, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tiervlei Trials Center, Stellenbosch University
City
Cape Town
State/Province
Cape Province
ZIP/Postal Code
8000
Country
South Africa
Facility Name
University of Cape Town Lung Institute
City
Cape Town
State/Province
Cape Province
Country
South Africa

12. IPD Sharing Statement

Links:
URL
http://www.tballiance.org
Description
Related Info

Learn more about this trial

PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis

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