Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)
A Phase II Dose Ranging Trial to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
1 other identifier
interventional
69
0 countries
N/A
Brief Summary
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2009
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
March 9, 2016
CompletedSeptember 20, 2019
September 1, 2019
5 months
July 21, 2009
February 19, 2014
September 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).
14 consecutive days of treatment
Secondary Outcomes (10)
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).
Two consecutive days of treatment
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).
Days 2-14 of 14 consecutive days of treatment
Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14).
Fourteen consecutive days of treatment
Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2).
Two consecutive days of treatment
Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14).
Days 2-14 of 14 consecutive days of treatment
- +5 more secondary outcomes
Study Arms (5)
PA-824 50 mg/qd
EXPERIMENTALPA-824 100mg/qd
EXPERIMENTALPA-824 150mg/qd
EXPERIMENTALPA-824 200mg/qd
EXPERIMENTALRifafour e-275mg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Informed Consent
- Body weight between 40 and 90 kg, inclusive.
- Newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB.
- A chest X-ray compatible with TB.
- Sputum positive
- Adequate volume of sputum
- Female participants of childbearing potential negative serum pregnancy and agree to use birth control
- Male participants must agree to use contraception throughout participation in the trial and for 12 weeks after last dose.
You may not qualify if:
- Poor general condition
- Rifampicin-resistant and/or Isoniazid-resistant
- MTB Treatment received within the 3 months prior
- Allergy to the IMP or related substances
- Evidence of extrathoracic TB
- A history of previous TB
- Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease
- History of lens opacity or evidence of lens opacity on slit lamp ophthalmologic examination
- Any evidence of renal impairment
- For males, any evidence or history of abnormality in the reproductive system
- History and/or presence (or evidence) of neuropathy or epilepsy.
- Clinically relevant changes in the ECG
- A history of or current clinically relevant cardiovascular disorder
- Concomitant use of any drug known to prolong QTc interval
- Diabetics using insulin
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Diacon AH, Dawson R, du Bois J, Narunsky K, Venter A, Donald PR, van Niekerk C, Erondu N, Ginsberg AM, Becker P, Spigelman MK. Phase II dose-ranging trial of the early bactericidal activity of PA-824. Antimicrob Agents Chemother. 2012 Jun;56(6):3027-31. doi: 10.1128/AAC.06125-11. Epub 2012 Mar 19.
PMID: 22430968RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel E. Everitt, MD, Vice President and Senior Medical Officer
- Organization
- Global Alliance for TB Drug Development
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Diacon, MD
Karl Bremer Hospital
- PRINCIPAL INVESTIGATOR
Rodney Dawson, MD
University of Cape Town Lung Institute
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 22, 2009
Study Start
August 1, 2009
Primary Completion
January 1, 2010
Study Completion
May 1, 2010
Last Updated
September 20, 2019
Results First Posted
March 9, 2016
Record last verified: 2019-09