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 Proportion of treatment emergent adverse events and treatment emergent serious adverse events.
- Secondary Outcome Measures
Name Time Method a)Safety and tolerability of ribavirin in moderate to severe LF<br>b)Unfavourable outcome (composite endpoint: AKI, ARDS, shock or encephalopathy or death)<br>c)Mean/median decline and AUC of AST, ALT, CK, LDH and CRP<br>d)Description of proinflammatory plasma cytokine levels (e.g. IFNa, TNFa, IL-6, IL-8) and lymphocyte phenotype under treatment<br>e)Description of evolution of viral loads and infectious titres over time until day 10.<br>f)Evolution of selected virus gene sequences under treatment <br>g)Population pharmacokinetics of ribavirin and dexamethasone<br>h)Time between treatment start and hospital discharge<br>i)Length of IMC/ICU stay<br>j)All-cause mortality on day of discharge