Health Condition 1: A90- Dengue fever [classical dengue]
Conditions
Interventions
Intervention1: AQCH and Standard Of Care: A. AQCH tablet 200 mg: It will be given as 200 mg (two tablets of 100 mg), thrice daily (every 8�±1 hours) at least 30 minutes before meals, for 7 days B. A
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willingness to provide written informed consent 2. Male or non-pregnant, non-lactating female aged greater than equal to 18 and less than equal to 65 years 3. Diagnosis of uncomplicated DF as defined by: a) Acute febrile illness (axillary greater than equal to 98.6�°F or oral greater than equal to 99.5�°F) with two or more of the following: a. headache b. retro-orbital pain c. myalgia d. arthralgia e. leukopenia f. thrombocytopenia g. no evidence of plasma leakage AND b) A positive result for Dengue infection on NS1 (Kit or ELISA) 4. Onset of fever less than or equal to 3 days before randomization 5. Platelet count greater than equal to 100,000/mm3
Exclusion criteria
Exclusion criteria: 1. Positive Rapid Diagnostic test for Malarial parasite antigen 2. Patients with DF with warning signs and symptoms -Compliant of Severe abdominal pain or tenderness -Persistent vomiting -Minor bleeding from different sites, scanty haemoptysis, haematemesis, haematuria, increase menstrual flow, gum bleeding,etc. -Palpitation, breathelessness -Hepatic dysfunction or hepatomegaly -Decrease urinary output as judged clinically -High haematocrit (greater than 45 percent) -Rapid fall in platelet count -Cold clammy extremities -Narrow pulse pressure (less than 20 mmHg) -Rapid pulse -Hypotension 3. Clinical suspicion of onset of Dengue Hemorrhagic Fever or Dengue Shock Syndrome 4. Patients with afebrile period without use of paracetamol for 24 hours preceding randomization 5. Laboratory abnormalities at Screening, including any of the following: -Haematocrit greater than 45 percent in males and greater than 40 percent in females -AST or ALT greater than 5 times ULN -SpO2 less than 90 percent -Absolute neutrophil count less than 1500/Ã?¼L -Serum Creatinine greater than 1.5 times ULN -Haemoglobin less than 11 g/dL for males and less than 10 g/dL for females -Total bilirubin greater than 2 times ULN 6. History of recent (less than 120 days of screening) transfusion of platelets or whole blood 7. Use of any anti-coagulant drugs or antiplatelet drugs including, but not limited to, warfarin, aspirin, clopidogrel, within the last 14 days prior to initiation of IMP 8. QTcF greater than 450 msec (males) or greater than 470 msec (females) or any other clinically significant ECG abnormality 9. Diagnosis of other infectious febrile illness e.g. Enteric fever, Pharyngitis, Tonsilitis, Influenza, Japanese encephalitis, Chikungunya etc. based on investigators clinical suspicion or if reports are available 10. Any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., peptic ulcer disease, coronary artery disease, COPD, asthma, immunocompromised patients etc.) that, in the opinion of the Investigator precludes the patientââ?¬•s participation in the study or interferes with the interpretation of the study results 11. History of serology positive for hepatitis B, hepatitis C, or human immunodeficiency virus 12. Woman of childbearing potential who doesnââ?¬•t agree to use a reliable method of contraception (e.g., total abstinence, intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study and for 4 weeks after the study. A sterile sexual partner is not considered an adequate form of birth control. Patients on hormonal contraceptives must have been on the same hormonal contraceptive for at least 3 months before screening and continue use throughout the duration of the study and for 4 weeks after the last study drug administration. (If a patient discontinues prematurely, the contraceptive method must be practiced for 4 weeks following final administration of IMP. Patients who are postmenopausal for at least 1 year (absence of menses for at least one year; a follicular stimulating hormone test may be performed to confirm menopause if the duration is l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary Safety Outcome measure: Proportion of patients who progress from uncomplicated DF to ââ?¬Ë?DF with warning signs and symptomsââ?¬â?¢ OR ââ?¬Ë?Severe Dengueââ?¬â?¢ Timepoint: From baseline till end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 6. Proportion of patients who develop severe thrombocytopenia defined as platelet count less than 20,000 /mm3 7. Proportion of patients with moderate bleeding 8. Proportion of patients with severe bleeding 9. Mean change in platelet count 10. Proportion of patients requiring transfusion of fluids 11. Virological parameters: a. Mean virological log reduction (VLR) b. Area under the log-transformed viremia curve (AUC) c. Time to NS1 clearanceTimepoint: 6. Baseline to end of study 7. Baseline to end of study 8. Baseline to end of study 9. Baseline to Day 7 10. Baseline to end of study 11. a) baseline (Day 1 pre-dose) to Day 3 and Day 5 11. b) baseline (Day 1 pre-dose) to Day 5 11. c) Baseline to end of study;Efficacy endpoints: 1. Proportion of patients clinically recovered by Test of Cure Visit on Day 8 2. Time from randomization to recovery 3. Time to fever clearance defined as afebrile period of 24 hours without paracetamol 4. Proportion of patients who develop shock defined as a pulse pressure of less than equal to 20 mmHg 5. Proportion of patients who develop moderate thrombocytopenia defined as a platelet count in the range of 50,000 to 20,000/mm3 Timepoint: 1. Test of Cure visit on Day 8 2. Randomization to recovery 3. Baseline to end of study 4. Baseline to end of study 5. Baseline to end of study;Safety endpoint: ââ?¬Â¢ Proportion of patients with Treatment Emergent Adverse Events (TEAEs)Timepoint: From baseline till end of study | — |
Countries
India
Contacts
Public ContactRajesh Gaikwad
Sun Pharma Laboratories Limited
Outcome results
None listed