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

Department of Health Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•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.

•1. Severe ARDS with PaO2/FiO2of <100 mm Hg and need for mechanical ventilation at the time of enrolment,
•2. Chronic home oxygen therapy,
•3. Chronic Kidney Disease (e-GFR of <30ml/min), Chronic Liver Disease
•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

发起方

Department of Health Research