Clinical trial NCT00567840: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Tuberculosis
Keywords: Early Bactericidal Activity
EBA
pulmonary tuberculosis
PA-824
Pretomanid
CL-007
Lead sponsor: Global Alliance for TB Drug Development
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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).
timeFrame: Day 0 and Day 14
Secondary outcomes:
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 0-2).
timeFrame: Day 0 and Day 2
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 2-14).
timeFrame: Day 2 and Day 14
measure: EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)
timeFrame: Day 0 and Day 14
measure: EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2)
timeFrame: Day 0 and Day 2
measure: EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified]
timeFrame: Day 2 and Day 14
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Tiervlei Trials Center, Stellenbosch University
state: Cape Province
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute
state: Cape Province
Study officials:
affiliation: UCT Lung Institute
name: Rodney Dawson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tiervlei Trial Center, Stelennbosch University, South Africa
name: Andreas Diacon, MD
role: PRINCIPAL_INVESTIGATOR
References: