A clinical trial to study safety and efficacy of AQCH tablets in adult patients with dengue fever

Phase 2

• Conditions: Health Condition 1: A90- Dengue fever [classical dengue]

• Registration Number: CTRI/2021/06/034040
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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/�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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Primary Safety Outcome measure: <br/ ><br>Proportion of patients who progress from uncomplicated DF to ââ?¬Ë?DF with warning signs and symptomsââ?¬â?¢ OR ââ?¬Ë?Severe Dengueââ?¬â?¢ <br/ ><br> <br/ ><br>Timepoint: From baseline till end of study <br/ ><br> <br/ ><br>