NCT00567840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

April 4, 2017

Completed
Last Updated

May 15, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

December 4, 2007

Results QC Date

February 15, 2017

Last Update Submit

April 10, 2017

Conditions

Pulmonary Tuberculosis

Keywords

Early Bactericidal ActivityEBApulmonary tuberculosisPA-824PretomanidCL-007

Outcome Measures

Primary Outcomes (1)

  • 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).

    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).

    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).

    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)

    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)

    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]

    Day 2 and Day 14

Study Arms (5)

1

EXPERIMENTAL

PA-824 200 mg/qd

Drug: PA-824

2

EXPERIMENTAL

PA-824 600 mg/qd

Drug: PA-824

3

EXPERIMENTAL

PA-824 1000 mg/qd

Drug: PA-824

4

EXPERIMENTAL

PA-824 1200 mg/qd

Drug: PA-824

5

ACTIVE COMPARATOR

Rifafour e-275 mg

Drug: PA-824

Interventions

PA-824DRUG

200 mg, 600 mg, 100 mg, 1200 mg qd

Also known as: Rifafour e-275
12345

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tiervlei Trials Center, Stellenbosch University

Cape Town, Cape Province, 8000, South Africa

Location

University of Cape Town Lung Institute

Cape Town, Cape Province, South Africa

Location

Related Links

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

pretomanid

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Daniel E. Everitt, MD, Vice President and Senior Medical Officer
Organization
Global Alliance for TB Drug Development
Dan.Everitt@tballiance.org
212-227-7540

Study Officials

  • Rodney Dawson, MD

    UCT Lung Institute

    PRINCIPAL INVESTIGATOR

  • Andreas Diacon, MD

    Tiervlei Trial Center, Stelennbosch University, South Africa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 15, 2017

Results First Posted

April 4, 2017

Record last verified: 2017-01

Locations

ZA(2)