PER-011-14RecruitingUnknown
PROSPECTIVE, RANDOMIZED, BLINDED PHASE 2 PHARMACOKINETIC/PHARMACODYNAMIC STUDY OF THE EFFICACY AND TOLERABILITY OF LEVOFLOXACIN IN COMBINATION WITH OPTIMIZED BACKGROUND REGIMEN (OBR) FOR THE TREATMENT OF MDR-TB
IVERSIDAD PERUANA CAYETANO HEREDIA,0 sites63 target enrollmentStarted: June 26, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 63
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65 (—)
- Sex
- All
Inclusion Criteria
- •1.Patients with smear-positive, culture positive* pulmonary TB
- •2.sputum contains isoniazid* and rifampin-resistant, Ofloxacin-susceptible MTB, all by MTBDR-sl
- •3.Previously treated or newly diagnosed with tuberculosis
- •4.Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 3 months prior to enrollment.
- •5.Age ≥ 18 years.
- •6.Weight > 40 Kg
- •7.Karnofsky score of > 60 (see section 18.1)
- •8.Willingness by the patient to attend scheduled follow-up visits and undergo study assessments.
- •9.Women with child-bearing potential must agree to practice an adequate barrier method of birth control or to abstain from heterosexual intercourse during study regimen.
- •10.Laboratory parameters (performed within 14 days prior to enrollment):
- •Estimated Serum creatinine clearance should be <50, using nomogram78
- •Hemoglobin concentration ≥ 9.0 g/dL
- •Platelet count of ≥ 80,000/mm3
- •Absolute neutrophil count (ANC) > 1000/ mm3
- •Negative pregnancy test (for women of childbearing potential) within 14 days of enrollment
- •HIV viral load and CD4 count if HIV infected (within 3 months)
- •Serum ALT and total bilirubin <3 times upper limit of normal
- •11.Able to provide informed consent
Exclusion Criteria
- •1.Currently breast-feeding or pregnant.
- •2.Known allergy or intolerance to or toxicity from fluoroquinolones or other medications utilized in this study.
- •3.In the judgment of the physician the patient is not expected to survive for 6 months
- •4.Anticipated surgical intervention for the treatment of pulmonary tuberculosis
- •5.Participation in another investigational drug trial within the past 30 days
- •6.Concurrent use of known QT-prolonging drugs: a list of such medications can be found at http://www.azcert.org/medical-pros/drug-lists/printable-drug-list.cfm
- •7.Poorly controlled diabetes
- •8.known g-6-phosphate dehydrogenase deficiency
- •9.Use of quinolone for 7 days within past 30 days
- •10.QTc interval greater than 450 msec for men or greater than 470 msec for women
Investigators
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