Table 1 Opti-Q study participant inclusion and exclusion criteria
Randomization inclusion criteria |
1. Patients with pulmonary TB |
2. Sputum that is isoniazid and rifampin-resistant by MTBDRplus and fluoroquinolone = susceptible by MTBDRsl |
3. HIV seropositive or seronegative but not unknown HIV serostatus. If the last documented negative HIV test was more than 3 months prior to randomization the current serostatus must be assessed |
4. Age ≥18 years |
5. Weight ≥40 kg |
6. Karnofsky score ≥60 at screening and randomization |
7. Willingness by the patient to attend scheduled follow up visits and undergo study assessments. |
8. Women with child-bearing potential must agree to practice adequate birth control or to abstain from heterosexual intercourse during study regimen |
9. Laboratory parameters (performed within 14 days prior to randomization): |
• Estimated Serum creatinine clearance should be ≥ 50, using nomogram |
• Hemoglobin concentration ≥ 9.0 g/dL |
• Platelet count ≥80,000/mm3 |
• Absolute neutrophil count (ANC) >1000/mm3 |
• Negative pregnancy test (for women of childbearing potential) during randomization/baseline |
• CD4 count if HIV infected (within 6 months) |
• Serum ALT and total bilirubin <3 times upper limit of normal |
10. Able to provide informed consent |
Randomization 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 TB |
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 https://crediblemeds.org/ |
7. Poorly controlled diabetes mellitus, defined as HgB A1c >9% |
8. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency |
9. Use of quinolone for 7 days within past 30 days |
10. QTc interval (Fridericia corrected) >450 msec for men and women at screening and randomization |