PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay
NCT ID: NCT01225640
Last Updated: 2016-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2011-08-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PNU-100480 600 mg BID
PNU-100480
600 mg twice daily (BID) for 14 days
PNU-100480 1200 mg QD
PNU-100480
1200 mg once daily (QD) for 14 days
RHZE
conjugated tablet with 4 drug combination of RHZE, Rifafour® e275 will be used in countries where can be sourced locally
RHZE
Combination tablet (RHZE) dosed by weight. Dosage strength per tablet is 150 mg Rifampicin (R)/75 mg Isoniazid (H)/400 mg Pyrazinamide (Z)/275 mg Ethambutol (E)
Interventions
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PNU-100480
600 mg twice daily (BID) for 14 days
PNU-100480
1200 mg once daily (QD) for 14 days
RHZE
Combination tablet (RHZE) dosed by weight. Dosage strength per tablet is 150 mg Rifampicin (R)/75 mg Isoniazid (H)/400 mg Pyrazinamide (Z)/275 mg Ethambutol (E)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight between 40 and 90 kg, inclusive (in light clothing, no shoes).
* Reasonably normal hemoglobin (\>=8 gm/dL), renal function (serum creatinine \<2 mg/dL), hepatic function (serum AST \<3xULN and total bilirubin \<1.3 mg/dL), and random glucose \<150 mg/dL.
Exclusion Criteria
* Presence of significant hemoptysis. Subjects who cough up frank blood (more than blood streaked sputum) will not be eligible.
* Pregnant or nursing females; females of childbearing potential unwilling or unable to adhere to contraception guidelines.
* Significant respiratory impairment (respiratory rate \>35/minute).
* Clinical suspicion of disseminated TB or tuberculosis meningitis.
* Subjects with diabetes mellitus on insulin and/or who have poorly controlled disease.
* Subjects with confirmed or suspected multi-drug resistant TB.
18 Years
65 Years
ALL
No
Sponsors
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Sequella, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Beth Ferstenberg, M.D.
Role: STUDY_DIRECTOR
Sequella, Inc.
Locations
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Pfizer Investigational Site
Bellville, Cape Town, South Africa
Pfizer Investigational Site
Cape Town, , South Africa
Countries
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References
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Wallis RS, Dawson R, Friedrich SO, Venter A, Paige D, Zhu T, Silvia A, Gobey J, Ellery C, Zhang Y, Eisenach K, Miller P, Diacon AH. Mycobactericidal activity of sutezolid (PNU-100480) in sputum (EBA) and blood (WBA) of patients with pulmonary tuberculosis. PLoS One. 2014 Apr 14;9(4):e94462. doi: 10.1371/journal.pone.0094462. eCollection 2014.
Other Identifiers
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B1171003
Identifier Type: -
Identifier Source: org_study_id
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