Effectiveness and safety of Glutathione injection in new onset lung problem caused by scrub typhus bacteria

Evaluation of Safety and Efficacy of Injectable Glutathione as an adjuvant to Standard of Care in Scrub typhus induced Acute Respiratory Distress Syndrome (ARDS): A Phase II, Multi-centric, Open label, Randomized Controlled Trial. - GIST

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051678

Enrollment

488

Registered

2023-04-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: J158- Pneumonia due to other specified bacteria

Interventions

Intervention1: INTERVENTION ARM: Standard of Care + Injection Glutathione, 600 mg three times a day for three days, diluted in 250 ml of Normal saline and infused over 30 minutes Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18-60 years, of all gender with laboratory confirmed Scrub typhus which is evident by IgM Card test / Immunofluorescence Assay (IFA) 2. Presence of mild to moderate Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin definition: a) Bilateral infiltrates by chest radiograph b) Oxygen saturation of less than 94% at rest on room air or the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2 ratio) of less than 300 and more than 100, and less than 48 hours from their hospital admission. c) Absence of other clinical conditions that could present in a similar manner (cardiogenic pulmonary oedema, non-infectious pneumonitis) d) Absence of moribund state that would indicate imminent demise and poor chance of survival.

Exclusion criteria

Exclusion criteria: 1. Severe ARDS with PaO2/FiO2of 2. Chronic home oxygen therapy, 3. Chronic Kidney Disease (e-GFR of 4. Use of any other antioxidant supplement outside the protocol 5. Prior hypersensitivity to glutathione 6. Pregnancy and lactation. 7. Multi organ dysfunction syndrome on admission

Design outcomes

Primary

Measure	Time frame
1. Overall mortality in intervention and control armTimepoint: At 28 days of follow-up	—

Secondary

Measure	Time frame
1. Proportion of patients needing mechanical ventilation and ventilator-free days 2. Mean change of ARDS severity based on Berlin classification at 72 hours and 96 hours after intervention 3. Mean change of SOFA scores at baseline, 72 and 96h after intervention 4. Length of ICU stay 5. Length of stay at the hospital 6. Incidence of infusion-related adverse events. 7. For patients who died, the number of Ventilator-free days will be 0, and for patients who are alive, the days not requiring mechanical ventilation during the 28-days will be the ventilator-free days. Timepoint: At 28 days of follow-up	—

Measure

Time frame

1. Proportion of patients needing mechanical ventilation and ventilator-free days 2. Mean change of ARDS severity based on Berlin classification at 72 hours and 96 hours after intervention 3. Mean change of SOFA scores at baseline, 72 and 96h after intervention 4. Length of ICU stay 5. Length of stay at the hospital 6. Incidence of infusion-related adverse events. 7. For patients who died, the number of Ventilator-free days will be 0, and for patients who are alive, the days not requiring mechanical ventilation during the 28-days will be the ventilator-free days. Timepoint: At 28 days of follow-up

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Countries

India

Contacts

Public ContactProf Dr S Lokesh

ICMR- National Institute of Epidemiology

lokeshsdr@gmail.com8825481583

Outcome results

None listed

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