Status:
COMPLETED
PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay
Lead Sponsor:
Sequella, Inc.
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
PNU-100480 is being developed for the treatment of both drug resistant and sensitive tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480 when given for 14 days ...
Eligibility Criteria
Inclusion
- Adult males or females between 18 and 65 years; women of childbearing potential must be willing to adhere to lifestyle requirements regarding contraception/pregnancy prevention.
- Newly diagnosed sputum smear-positive pulmonary TB confirmed with acid-fast bacillus (AFB) smear and chest x-ray. Patients with TB more than 5 years ago who completed treatment, are healthy, and meet other inclusion criteria may be included.
- 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
- HIV infection with helper/inducer T-lymphocytes (CD4 cell) count of \<=350x10-6/L.
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01225640
Start Date
August 1 2011
End Date
December 1 2011
Last Update
January 14 2016
Active Locations (2)
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1
Pfizer Investigational Site
Bellville, Cape Town, South Africa, 7530
2
Pfizer Investigational Site
Cape Town, South Africa, 7700