Corticosteroids for smear-positive HIV-negative pulmonary tuberculosis

Corticosteroids for smear-positive HIV-negative pulmonary tuberculosis - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031200344

Enrollment

Registered

2021-02-05

Start date

2021-07-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary tuberculosis pulmonary tuberculosis

Interventions

Prednisolone (20-30 mg/day based on patient's weight, oral, 21 days)

D005938

Corticosteroids

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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= 38.0 *Can be man or woman *Age of 20 years or more *Agreement of the patient

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Infectivity negative conversion	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactNobuyuki Horita

Yokohama City University Hospital

horitano@yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026