Health Condition 1: B519- Plasmodium vivax malaria without complication
Conditions
Interventions
Intervention1: Zintrodiazine: Dose : 900 mg
Route: Oral
Frequency : Single Dose
Duration: Single Dose
Control Intervention1: Lariago-DS: Dose : 500 mg
Route: Oral
Frequency :two tablets followed by tw
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Ability to swallow oral medication. 2)Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study and that all questions by the participant have been sufficiently answered. 3)Participants who are willing to and are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 4)Microscopic confirmation of P. vivax by thin and thick blood smear with parasite density of greater than 250 parasites per microL 5)Axillary temperature greater than equal to 37.5 C or history of fever within 24 h of screening. 6)Age greater than 18 years and body weight greater than 45 kg 7)Hemoglobin greater than 9 gram per dL
Exclusion criteria
Exclusion criteria: 1)Mixed Plasmodium infection. 2)Signs and symptoms of severe malaria (WHO 2015 criteria ). 3)History of having received any antimalarial treatment (alone or in combination) during the following periods before screening: a)Piperaquine, mefloquine, naphthoquine, or sulfadoxine-pyrimethamine within 6 weeks prior to screening b)Amodiaquine and chloroquine within 4 weeks prior to screening c)Any artemisinin derivative (artesunate, artemether, or dihydroartemisinin), quinine, lumefantrine, or any other antimalarial treatment or antibiotic with antimalarial ac-tivity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within 14 days prior to screening 4)Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstances within 3 months of screening. 5)Known allergy to the study drugs (pyronaridine derivatives/artemisinin derivatives/lumefan-trine/chloroquine) and its excipients. 6)Patients who have recently received quinacrine or concurrently receiving other potentially hemolytic drugs or depressants of myeloid elements of the bone marrow. 7)Pregnant or nursing (lactating) women. 8)Sexually active participants not willing to take effective contraception measures; for female participants, oral or injectable contraceptive pills, intrauterine device (IUD), intrauterine hor-mone-releasing system (IUS), bilateral tubal occlusion, or vasectomized partner. 9)All male participants not intend to use either true abstinence, barrier method, or other effec-tive means of contraception. 10)Participation in other clinical studies within 90 days before first IMP administration and/or during study participation. 11)Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the investiga-tor, would make the participant inappropriate for entry into this study. Examples would in-clude but not limited to: a)Known Tuberculosis b)Concurrent febrile illness, e.g., Typhoid fever or known or suspected COVID-19 in-fection c)Immunological disorders (including known or suspected seropositive HIV antibody) d)Severe psychiatric disorders (active depression, recent history of depression, gener-alised anxiety, psychosis, schizophrenia, or other major psychiatric disorders) and major medical disorders related to cardiovascular, respiratory, renal, gastrointestinal, endocrine, infectious, malignancy, neurological (including auditory) and history of convulsions or other abnormality e)Clinical signs or symptoms of hepatic injury (such as abdominal pain associated with jaundice) or known severe liver disease (i.e., decompensated cirrhosis, Child-Pugh stage 3 or 4), history of hepatitis B or C, hepatitis B or A vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis f)History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia, or severe heart disease. Use of agents known to prolong the QT interval unless it can be permanently discontinued for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Zintrodiazine as measured by ACPRTimepoint: ACPR at Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Zintrodiazine as measured by ACPRTimepoint: on Day 14;To evaluate the safety and tolerability of Zintrodiazine in Indian adults with uncomplicated P. vivax malaria.Timepoint: at Days 14 and 28.;To evaluate fever clearance.Timepoint: Baseline to EOS;Parasite clearance time (PCT).Timepoint: Baseline to Parasite clearance time. | — |
Countries
India
Contacts
Public ContactDr Kevinkumar Kansagra
Zydus Lifesciences Ltd
Outcome results
None listed