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Role of Additional steroids in lung disease due to scrub typhus

Role of Adjunctive corticoSTEROIDS on clinical outcomes in severe scrub typhus pneumonitis a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077709
Enrollment
440
Registered
2024-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: A753- Typhus fever due to Rickettsia tsutsugamushi

Interventions

Intervention1: Dexamethasone: Day 1 to 3 Dexamethasone 6 mg IV administered slow IV push day 4 Dexamethasone 6 mg IV administered once daily assessment on day 4 to see if steroids need to be continued

Sponsors

Christian Medical College CMC Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults with a diagnosis of severe scrub typhus pneumonitis as defined below SpO2 less than 90 on room air OR SpO2 less than 92 on greater than equal to 4 litres of O2 OR Pulmonary SOFA score of 2 or more OR Need for ventilatory support with or without another organ dysfunction Duration of symptoms 12 days Scrub typhus rapid test positivity Willingness to participate in the study and written informed consent Other organ dysfunction excluding the need for high dose inotropes defined as the organ specific Sequential Organ Failure Assessment score of 1 or more

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Treatment for more than 24 h with 6 mg of dexamethasone or equivalent dose of corticosteroids prior to enrollment Treatment will inhaled corticosteroids is not an exclusion Treatment with doxycycline and/or azithromycin for more than 48 h prior to enrollment Treatment with other antibiotics for longer duration is not an exclusion criterion Active tuberculosis HIV infection recent steroid use chemo other immunosuppressant therapy or herbal remedies containing steroids Allergies to the study drug Prolonged treatment outside more than 5 days due to increased infection risk If patients have another indication for the use of corticosteroids example shock requiring vasoactive agents anaphylaxis asthma flare etc

Design outcomes

Primary

MeasureTime frame
The primary outcome is a composite variable, considered a failure (coded as 0), if a patient within 28 days dies or remains intubated and awarded a VFD of 0 (i.e., patients who died are considered to have no VFDs). It is considered a success if a patient is extubated before 28 days, and alive at day 28, and defined as days between extubation and day 28Timepoint: at baseline, after 28 days

Secondary

MeasureTime frame
mortalityTimepoint: 28 days;Need for respiratory support, defined as the requirement of invasive mechanical ventilation and/or non-invasive ventilation (NIV) and/or high frequency nasal cannula (HFNC) use.Timepoint: 28 days;Duration of ventilationTimepoint: 28 days;Association between expression of ANA and steroid responsivenessTimepoint: not applicable;Association between CRP, IL-6 and Ferritin and illness severity and outcomesTimepoint: not applicable

Countries

India

Contacts

Public ContactPeter John Victor

Christian Medical College, Vellore

peterjohnvictor@yahoo.co.au9626793284

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026