ADEX (LAssa fever adjunct treatment with DEXamethasone)
- Conditions
- Lassa fever
- Registration Number
- PACTR202402557039838
- Lead Sponsor
- Bernhard Nocht Institute for Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
Age = 18 years
-LF confirmed by RT-PCR with a Ct value < 30
-Signs of significant health impairment as evidenced by any of the following:
oACVPU other than A
oSystolic blood pressure < 90 mmHg
oSeizure(s), meningism, coma, focal neurological deficit
oAST (GOT) >3xULN
oALT (GPT) > 3xULN
oKDIGO 2 or more severe based on serum creatinine only (where preceding value of creatinine is not available, the upper limit of the normal range should be used as reference)
oActive macroscopic bleeding
oO2 saturation < 92
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method