Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: study protocol for a prospective, multicenter, randomized, open-label, phase II trial

Table 2 Study timeline

Visit	Screening	Baseline visit^a	Treatment
Visit number	1	2	3	4	5	6	7	8	9	10
Weeks (w)	−2 w to −1 d	0	1 w	2 w	4 w	8 w	12 w	16 w	20 w	24 w
Visit window	NA	NA	±4 d	±4 d	±1 w	±2 w	±2 w	±2 w	±2 w	±2 w
Consent	X
Randomization		X
Medical history	X
Physical examination	X		X	X	X	X	X	X	X	X
Neurologic examination	X		X	X	X	X	X	X	X	X
Xpert MTB/RIF® assay	X
Sputum AFB smear	X	X^d	X	X	X	X	X	X	X	X
TB culture (solid)	X	X^d	X	X	X	X	X	X	X	X
TB culture (liquid)	X	X^d	X	X	X	X	X	X	X	X
DST^b	With first cultured Mycobacterium tuberculosis
CXR	X	X^d			X	X	X	X	X	X
HIV, HBV	X
Total bilirubin, AST/ALT, creatinine	X	X^d	X	X	X	X	X	X	X	X
Complete blood count	X	X^d	X	X	X	X	X	X	X	X
Optic test		X	X	X	X	X
Urine HCG^c	X
Compliance of drug intake			X	X	X	X	X	X	X	X
Adverse drug reaction			X	X	X	X	X	X	X	X
Other medications^e		X	X	X	X	X	X	X	X	X

w weeks, d days, NA not applicable, AFB acid-fast bacilli, TB tuberculosis, DST drug susceptibility test, CXR simple chest radiography, HIV human immunodeficiency virus, HBV hepatitis B virus, AST aspartate transaminase, ALT alanine transaminase, HCG human chorionic gonadotropin
^aTreatment will be initiated at the baseline visit, as TB treatment should be started promptly following diagnosis
^bDrug susceptibility test for isoniazid, rifampicin, ethambutol, pyrazinamide, streptomycin, kanamycin, amikacin, capreomycin, ofloxacin, levofloxacin, moxifloxacin, prothionamide, cycloserine, and para-aminosalicylic acid
^cOnly in females of childbearing potential
^dCan be omitted if the results of previous tests within the prior 4 weeks are available
^eIn particular, immunosuppressive agents (including corticosteroids)

ISSN: 1745-6215