Treatment shortening of drug-sensitive pulmonary tuberculosis using high-dose rifampicin for 3 months after culture conversion (Hi-DoRi-3): a study protocol for an open-label randomized clinical trial

Table 4 Timeline for the investigational group

Type	Screening^a	Baseline^a	Treatment				End of treatment (EOT)^h	Follow-up				End of study (EOS)
Visit name	Screening	D0	W2	W4	W6	W8	W12 ~ (Every 4 W)	EOT + 3 M	EOT + 6 M	EOT + 9 M	EOT + 12Mⁱ	M18ⁱ
Weeks (w)	− 14 ~ 0 days	0	2 W	4 W	6 W	8 W	12 W/16 W/20 W/24 W /28 W/32 W	EOT + 13 W	EOT + 26 W	EOT + 39 W	EOT + 52 W	78 W
Visit window	n-a	n-a	± 4 days	± 4 days	± 4 days	± 4 days	± 2 weeks	± 6 weeks	± 6 weeks	± 6 weeks	± 6 weeks	± 6 weeks
Consent	O
Randomization		O
Medical history	O
Physical exam	O	O	O	O	O	O	O	O	O	O	O	O
Xpert MTB/RIF assay	O^e
Sputum AFB smear	O^e	O^e	O	O	O	O	O	O	O	O	O	O
TB culture (liquid)	O^e	O^e	O	O	O	O	O	O	O	O	O	O
DST^b	With first/reverted cultured MTB
Chest X-ray	O^e	O^e		O		O	O	O	O	O	O	O
Chemistry^c	O^e	O^e	O	O	O	O	O^h
Complete blood count	O^e	O^e	O	O	O	O	O^h
HIV	O^e
Urine (or blood) HCG^d	O	O	O	O	O	O	O^h
HBV/HCV^f		O^e
Compliance of drug intake			O	O	O	O	O^h
Adverse drug reaction			O	O	O	O	O^h	O
Other medication^g	O		O	O	O	O	O^h

^a It can be performed with the baseline visit if all screening results can be checked on the day
^b Drug susceptibility test for isoniazid, rifampicin, ethambutol, pyrazinamide, streptomycin, kanamycin, amikacin, capreomycin, ofloxacin, levofloxacin, moxifloxacin, prothionamide, cycloserine, rifabutin, and para-aminosalicylic acid (Omitted for the patients whose results are already reported)
^c Test items according to the standard treatment guidelines (refer to 6. Study procedures)
^d Performed for women of childbearing age tested within 7 days
^e The existing test results can be extracted and collected without additional testing if the previous test was performed within 4 weeks (based on the report day for the TB culture)
^f Since HBsAg and Anti-HCVAb are not excluded even if they are positive, drugs can be administered even before the results are reported
^g Confirmation of concomitant drugs, especially immunosuppressants including oral steroids
^h The date of the end of treatment is determined according to the time of culture conversion to negative. A visit every 4 weeks until EOT and every 3 months after EOT. The test is not performed after EOT
ⁱ If the 78-week visit (EOS) after randomization arrives earlier than the EOT + 12 M visit, the EOT + 12 M visit is omitted, and the EOS visit proceeds

ISSN: 1745-6215