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Table 4 Study timeline for investigational 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 treatment (EOT)g

EOT to end of study

Weeks (w)

–2 w ~  –1 d

0

1 w

2 w

4 w

8 w

12 w ~ (every 4w)

40 w ~  52 w

~  24 months (every 2 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 g

 

Neurological exam

X

 

X

X

X

X

X

X g

 

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

Resistance test

If needed (for linezolid, delamanid)

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 g

 

Complete blood count

X e

X e

X

X

X

X

X

X g

 

ECG

X e

X e

X

X

X

X

X

X g

 

Urine HCGc

X

X

X

X

X

X

X

X g

 

HIV, HBVd

 

X e

       

Optic test

X

X

X

X

X

X

X

X g

 

Compliance of drug intake

  

X

X

X

X

X

X g

 

Adverse drug reaction

  

X

X

X

X

X

X g

 

Other medicationf

X

X

X

X

X

X

X

X g

 
  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 study visit will be determined by the time of culture conversion. Omit test after end of treatment visit
  9. hCan be omitted if previous test was done within 2 weeks
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Trials

ISSN: 1745-6215