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Table 3 Study timeline for control arm

From: Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial

  Screening Baseline
visita 		Treatment End of treatmentg
(End of study)
Weeks (w) –2 w ~ –1 day 0 1 w 2 w 4 w 8 w 12 w ~
(every 4w) 		52 w ~
(every 2 months) 		80 w ~
24 months
Visit window NA NA ± 4 days ± 4 days ± 1w ± 2w ± 2 w ± 2 w ± 2 w
Consent X         
Randomization   X        
Medical history X         
Physical exam X   X X X X X X X
Neurological exam X         
Sputum AFB smear X e X e X X X X X X X
TB culture (solid) X e X e X X X X X X X
TB culture (liquid) X e X e X X X X X X X
Genotypic DST If available
Phenotypic DSTb With first/reverted cultured Mycobacterium tuberculosis
CXR X e X e X h X h X X X X X
Chemistry, electrolytes X e X e X X X X X X X
Complete blood count X e X e X X X X X X X
ECG X e         
Urine HCGc X X        
HIV, HBVd   X e        
Optic test X         
Compliance of drug intake    X X X X X X X
Adverse drug reaction    X X X X X X X
Other medicationf X X X X X X X X X
  1. AFB acid-fast bacilli, CXR chest x-ray, DST drug susceptibility testing, ECG electrocardiogram, HBV hepatitis B virus, HCG human chorionic gonadotropin, HIV human immunodeficiency virus, NA not applicable, TB tuberculosis
  2. aAdministration of anti-TB regimen can begin at baseline visit since drug-resistant TB must be treated immediately
  3. bDrug susceptibility test for isoniazid, rifampicin, ethambutol, pyrazinamide, streptomycin, kanamycin, amikacin, capreomycin, ofloxacin, levofloxacin, moxifloxacin, prothionamide, cycloserine, and p-aminosalicylic acid (can be omitted for patients with results already provided)
  4. cOnly in females of childbearing potential (blood HCG test results are available)
  5. dStudy drugs can be administered before obtaining the results since eligibility is not determined by these results
  6. eCan be omitted if previous tests except ECG were done within 4 weeks. In case of ECG, within 1 week
  7. fCheck prohibited drugs for exclusion criteria at screening visit and check immunosuppressants including steroids after enrollment
  8. gEnd of treatment visit will be determined by the time of culture conversion
  9. hCan be omitted if previous test was done within 2 weeks
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Trials

ISSN: 1745-6215