LAssa Fever Adjunct Treatment With DEXamethasone
Safety and Tolerability of Adjunct Dexamethasone in Addition to Standard of Care Antiviral Therapy Compared to Standard of Care Antiviral Therapy Alone for the Treatment of Moderate to Severe Lassa Fever
Bernhard Nocht Institute for Tropical Medicine
42 participants
Feb 5, 2024
INTERVENTIONAL
Conditions
Summary
Dexamethasone is a corticosteroid which can modulate inflammatory-mediated tissue damage associated with a wide range of infectious diseases. Dexamethasone is routinely used for treatment of tuberculous meningitis and for pneumococcal meningitis in adults. In Coronavirus Disease 2019 (COVID-19) dexamethasone is also effectively preventing immune mediated damage of the lungs. There is also indication that dexamethasone may be promising in severe LF.
Eligibility
Inclusion Criteria11
- Age ≥ 18 years
- LF confirmed by RT-PCR (reverse-transcription polymerase chain reaction) with a cycle threshold (Ct) value < 30
- Signs of significant health impairment as evidenced by any of the following:
- Alert, confusion, voice, pain, unresponsive (ACVPU) other than A
- Systolic blood pressure < 90 mmHg
- Seizure(s), meningism, coma, focal neurological deficit
- AST (GOT) >3xULN
- ALT (GPT) > 3xULN
- KDIGO 2 or more severe based on serum creatinine only
- Active macroscopic bleeding
- O2 saturation < 92
Exclusion Criteria6
- Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- Lactation following live birth
- Known intolerance and contra-indications to ribavirin or dexamethasone
- Patients who already received a corticosteroid within the preceding 7 days
- Investigator's valuation that patient might be put to substantial risk by participating in this trial
- Patients receiving end-of-life care as judged by the investigator
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Dexamethasone will be administered for 10 days. For the first 48 hours, dexamethasone will be given iv. After 48 hours, a switch to oral dexamethasone (same dosage) is permitted at the discretion of the study physician.
Ribavirin treatment will be administered iv for 10 days, as recommended in the Nigeria Centre for Disease Control and Prevention National Guidelines for LF Case Management.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06222723