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The effect of moderate-dose and high-dose intravenous methylprednisolone combined with plasmapheresis versus plasmapheresis alone in improving clinical outcome of patients with leptospirosis pulmonary haemorrhage syndrome

A multicenter open-labelled randomized controlled trial to evaluate the effect of moderate-dose and high-dose intravenous methylprednisolone combined with plasmapheresis versus plasmapheresis alone in Leptospirosis pulmonary haemorrhage syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2024/037
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-12-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Leptospirosis pulmonary haemorrhage

Interventions

Study will be conducted at Colombo South Teaching Hospital, National Hospital of Sri Lanka Teaching Hospital Karapitiya and Colombo North Teaching Hospital* (*added on 14.08.2026) A balanced design w
IV Ceftriaxone 1g BD for 7 days, Renal replacement therapy for acute kidney injury, respiratory support for pulmonary haemorrhage and blood product transfusions for coagulopathy will be continued as p

Sponsors

University of Sri Jayewardenepura
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Suspected leptospirosis patients with evidence of leptospirosis pulmonary haemorrhage syndrome (defined as the presence of one or more of haemoptysis, arterial hypoxemia, haemoglobin reduction >10% from baseline with radiographic evidence of pulmonary haemorrhage) - Males and females

Exclusion criteria

Exclusion criteria: - Patients <18 years of age - Pregnancy - Patients on long-term glucocorticoids - Patients with active co-infections on recruitment (eg: dengue, sepsis, tuberculosis, systemic fungal infections) - Patients with underlying bleeding disorders - Patients with pre-existing lung diseases interfering with chest radiograph interpretation (eg: interstitial lung disease, bronchiectasis)

Design outcomes

Primary

MeasureTime frame
All cause in-hospital mortality [At hospital discharge or death]

Secondary

MeasureTime frame
- Development of hospital-acquired infections Criteria for hospital-acquired infections: -Ventilator-associated pneumonia defined as having new or progressive infiltrates in chest radiograph with clinical/laboratory features suggestive of infection (leucocytosis, elevated C reactive protein, fever) in a patient on mechanical ventilator - Urosepsis: Clinical/laboratory features of new infection with positive urine culture or suggestive urinalysis - Catheter-related blood stream infections: Clinical/laboratory features of new infection with positive catheter and blood culture positivity from the same micro-organism - Cannula-site infection: Clinically apparent cannula site infection (local redness, warmth in a site of cannula placement [At hospital discharge or death] Duration of respiratory support (length of mechanical ventilation, duration of HFNO/NIV therapy) [ At hospital discharge or death] Duration of ICU stay [ At hospital discharge or death] Duration of hospital stay [ At hospital discharge or death] Side effects of steroid therapy (hyperglycaemia, high blood pressure, hyponatraemia, peptic ulcer disease) [ At hospital discharge or death]

Countries

Sri Lanka

Contacts

Public ContactDr Nilanka Perera

Senior Lecturer

nilanka@sjp.ac.lk+94112758000 (4300)

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Sep 19, 2026