Corticosteroids for smear-positive HIV-negative pulmonary tuberculosis

JRCT ID: jRCT1031200344

Registered date:05/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pulmonary tuberculosis
• Date of first enrollment: 12/07/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Prednisolone (20-30 mg/day based on patient's weight, oral, 21 days)

Outcome(s)

• Primary Outcome: Infectivity negative conversion

Secondary Outcome

The secondary endpoints will be evaluated after propensity score matching.
1) In-hospital mortality within 4 weeks
2) Time to infectivity negative conversion
3) Change of BT and P/F ratio during the first 3 days.
4) Change of CRP, transferrin, pre-albumin, retinol binding protein, and lymphocyte count during the first 7 days.
5) change of albumin and hemoglobin during the first 21 days.
6) Culture negative conversion during the first 4 weeks.
7) Treatment discontinuation due to drug-induced rash during the first 4 weeks.
8) Infectivity negative conversion rate alive.
9) Exploratory biomarkers measurements.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

A patient should satisfy all of below.
*Anti-TB treatment has not been started for the episode.
*Smear positive
*PCR or LAMP proved.
*Planned to be treated by HRZE or HRE
*None-HIV
*Satisfying 1 or more of the followings: SpO2<94%, serum alb < 3.5 g/dL, BT >= 38.0
*Can be man or woman
*Age of 20 years or more
*Agreement of the patient

Exclude criteria

*Not being able to be treated with oral HRZE or HRE
*HbA1c >10
*History of GI bleeding
*Estimated life prognosis less than 1 months due to non-tuberculosis disease
*Currently pregnant, potentially pregnant, or breast feeding.(If a patient who denies the possibility of pregnancy on admission is found to be pregnant during hospitalization, the steroid will be promptly tapered off and the patient will be dropped off from the study. No contraceptive guidance is given during the treatment and the postobservation period, as no new pregnancies are expected to occur during this period of hospitalization)
*Treated by desmopression.
*History of tuberculosis treatment
*Having stayed outside of Japan for mothe than 1 months during the last half year.
*Traveler from other countries.
*Other medical reason judged by a physician.

Related Information

• Primary Sponsor: Horita Nobuyuki
• Source(s) of Monetary Support: DAIICHI SANKYO Co., Ltd.