Dengue
Conditions
Interventions
Study setting: The study will be conducted at the National Institute of Infectious Diseases (NIID), Angoda. Patients who visit the OPD of the NIID and diagnosed with dengue, confirmed by a positive NS
Sponsors
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Eligibility
Inclusion criteria
Inclusion criteria: • Laboratory evidence of Dengue: All Patients with confirmed dengue infection by a positive dengue NS1 antigen detection test and confirmed by PCR test. The dengue NS1 antigen will be done by rapid immunochromatographic assays (rapid strip tests at the OPD). Those who provides informed written consent and who fulfil all of the following criteria will be recruited. • Age: between 18-70 * Both male and female • Duration of illness: Equal or less than 48 hours of the onset of fever
Exclusion criteria
Exclusion criteria: Those who already have evidence of fluid leakage. • Fever for more than 48 hours • Pregnant women • Those who have known allergies to ingredients of LNS. • Those who are unable to take the drugs orally. • Those who have known hepatic impairment defined as following: All of the 3 following criteria should be present. • Presence of any previously known liver disease • A prolonged prothrombin time of 4-6 seconds or more • An INR of >1.5 • Those with known renal impairment. They will be defined as those who fulfil either of the following criteria regardless of age, hypertension and diabetes. Patients will be inquired regarding presence of diabetes and hypertension and any pre-existing renal disease . They would have renal impairment if they have any of the following. - Predicted GFR <60 ml/min per 1.73 m2 - Hereditary kidney disease - Recurrent or extensive nephrolithiasis (renal calculi)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of dengue patients who progress into critical phase. Evidence of plasma leakage will be considered as: detection of free fluid in the abdomen or by the presence of a pleural effusion by an ultrasound (US) scan or by the presence of a rise in haematocrit of >20% of the baseline. [FBC will be done twice daily, Clinical assessments will be carried out at least 3 times a day until discharge] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Average Duration of the illness: The first day of the illness will be defined as the day in which the patient developed fever. The day of recovery will be defined when all three following criteria are fulfilled: 1.a Improvement in clinical status (general well-being, appetite, haemodynamic status, urine output, no respiratory distress determined by a medical investigator at NIID who is blinded to the investigation arm of the patient (placebo or IMP). Further the recruited OPD patients will be advised to come to the OPD for daily assessment as per usual practice at NIID and at the OPD medical investigator at NIID will assess the criterion. He/she is blinded to the investigation arm of the patient (placebo or IMP). 1.b Increasing trend in the platelet count as measured by a minimum of 2 readings 1.c Stable haematocrit without intravenous fluids [Baseline and FBC will be done twice daily after intervention, Clinical assessments will be carried out at least 3 times a day until discharge.FBC and clinical assessment will be carried out daily in the outpatient setting until recovery ] 2. Change of liver enzymes (AST and ALT), prothrombin time and serum creatinine from baseline to day 10. [Baseline to day 5 & 10 from intervention] c) Change of cumulative symptom score from baseline to day 10. The 15 symptoms assessed would be fever, headache, joint pain, muscle pain, rashes, nausea, vomiting, loss of appetite, sleep disturbances, malaise (lack of wellbeing), fatigue (extreme tiredness), abdominal pain, restlessness, sweating, dizziness. Each symptom will be scored daily by the patient as absent (score 0), mild (1), moderate (2) or severe (3). [ Baseline and daily unitl? [for OPD?]] d) Average fatigability score at day 15, 30, 45 and 60 assessed using using validated Chalder Fatigue questionnaire [at day 15, 30, 45 and 60 [from what?]] b) Change of liver enzymes (AST and ALT), prothrombin time and serum creatinine . [ Baseline, Day 5 and day 10 [?]] c) | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Jennifer Perera,
Emeritus Professor, University of Colombo
Outcome results
None listed