Dengue disease Infections and Infestations Dengue fever [classical dengue]
Conditions
Interventions
Current interventions as of 15/11/2012:
Patients will be assigned to one of two treatment arms:
Active Medicinal Product:
1. COHORT 1 - 40 mg lovastatin
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 2. Clinical suspicion of dengue 3. <72 hours of fever 4. Positive rapid test for dengue non-structural protein 1 5. Informed consent or assent to participate in the trial
Exclusion criteria
Exclusion criteria: Patients with one or more of the following criteria at enrolment will be excluded from the study: 1. Signs or symptoms suggestive of any other acute infectious disease 2. Alanine aminotransferase (ALT) >150 U/L 3. Creatine kinase (CK) >1000 U/L 4. Myopathy 5. Cirrhosis 6. Use of statins within 1 week 7. Chronic use of medication contraindicated for use with lovastatin (cholestyramine, isradipine, warfarin, amiodarone, azole antifungals, fibrates, colchicine, ciclosporin, danazol, macrolides, nefazodone, niacin (high doses), protease inhibitors, verapamil, diclofenac, doxycycline, imatinib, isoniazid, nicardipine, propofol, quinidine, and diltiazem) 8. Pregnancy and lactation (all females of childbearing potential must provide urine for a âHCG test) 9. Platelet levels below 50 x 10^9/L (added as of 15/11/2012)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of lovastatin in adult patients with dengue including rate of adverse events in each cohort | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease progression as defined by one or more of the following: 1.1. Admission to intensive care unit 1.2. Diagnosis of shock (see definition) 1.3. Development of severe bleeding (see definition) 1.4. CNS involvement 1.5. Death 2. Fever clearance time (defined as the time from enrolment to the first time the temperature falls to < 37.5 degree C and remains below this level for 48 hours) 3. Plasma viraemia - AUC day 3 - 6 (log10-transformed) Additional experimental endpoints include: 2. Haematological, biochemical and physiological abnormalities: 2.1. Platelet nadir between day 3 and 8 of illness 2.2. Maximum haematocrit between day 3 and 8 of illness 2.3. Percentage increase in haematocrit between day 3 and 8 of illness from baseline 2.4. Maximum alanine aminotransferase (ALT) and Creatine kinase (CK) recorded between day 3 and 8 of illness 2.5. Lowest oxygen saturation recorded between day 3 and 8 of illness 2.6. Number of patients in each group requiring colloid 3. Quality of life scores from visual analog scale during treatment (quantifiable self-measurement of quality of life in relation to personal health) 4. Virological safety parameters: 4.1. Duration from enrolment to the first undetectable viremia measurement 4.2. Duration from enrolment to first negative NS1 measurement | — |
Countries
Viet Nam
Outcome results
None listed