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

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: 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: Control arm: Standard of Care CONDITION: Health Condition 1: J158‐ Pneumonia due to other specified bacteria PRIMARY OUTCOME: 1. Overall mortality in intervention and control armTimepoint: At 28 days of follow‐up SECONDARY OUTCOME: 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 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.
Epistemonikos ID: a93cfebe1a8ad2d84b1cb45c105662f568ed990f
First added on: Feb 20, 2024