Health Condition 1: B509- Plasmodium falciparum malaria, unspecified
Conditions
Interventions
Intervention1: Artesunate with Sulfadoxine and Pyrimethamine plus Curcumin (Biocurcumax capsule): Patients will receive Biocurcumax 2g (4 capsules of 500mg) twice a day for 3 days as add on to oral Ar
Sponsors
ICMR National Institute for Malaria Research
Ispat General Hospital
Shaheed Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition. Patients with negative test result for the Rapid Antigen Detection Test for COVID-19. Presence of clinical manifestation of acute malaria along with presence of fever (axillary temperature greater than or equal to 37.5 degree C or oral greater than or equal to 38 degree C) or a documented history of fever in the past 24 hours. Peripheral blood smear positive for asexual form of P. falciparum. Mono infection with P. falciparum. The peripheral parasitemia within 1,000 to 1,00,000 asexual P. falciparum parasites per µL of blood. Patient must understand and be able, willing and likely to fully comply with study procedures and restrictions. Patients ready to undergo a follow-up of 28 days. Patient must have given written, personally signed and dated, informed consent to participate in the study, in accordance with the current applicable regulations, International Conference on Harmonization (ICH), Good Clinical Practice (GCP) Guidelines, before completing any study related procedures. (In case of illiterate patients, patient’s thumb impression and signature of impartial witness is necessary on informed consent).
Exclusion criteria
Exclusion criteria: Patients with severe malaria as per WHO criteria. Mixed infection with another Plasmodium species at the time of presentation (including P. vivax, P. ovale and P. malariae). Patients with clinically relevant bradycardia or with chronic cardiac disease, chronic kidney or liver disease. Patients with diarrhea defined as greater than 3 episodes of watery stools in the previous 24 hours or patients who have had 3 episodes of vomiting within 24 hours prior to screening. Any other underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis, bacterial infection; cardiac or pulmonary disease) Patients with known significant renal or hepatic impairment (Serum creatinine greater than 1.5 x upper limit of normal (ULN), Aspartate transaminase >2.5xULN, Alanine transaminase greater than 2.5xULN, Serum bilirubin greater than 3 mg per dl). Patients with history of human immunodeficiency virus (HIV) infection or other immunosuppressive disorders, evidence of clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, endocrine diseases, and malignant disorders that may interfere with evaluations of this study. Patients with hemoglobin (Hb) level of less than 8 gm per dl. Patients with severe hypertension SBP greater than 180 and or DBP greater than 110 mm Hg. Patients who had taken any antimalarials in the previous 1 month. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole etc. Known allergy to artesunate, artemether or any other artemisinin derived products, Sulphadoxine-Pyrimethamine or any other related drugs. Patients with history of drug dependence, other substance abuse or excessive alcohol intake on habitual basis of more than two units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of study. Patients who have used another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment. Pregnant or lactating women. Women of childbearing potential not practicing contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28. Safety parameters will be incidence of adverse events and its severity, clinically significant changes in laboratory parameters from baseline to end of therapy evaluations and vital signs and abnormalities observed during physical examination.Timepoint: Day 0, 1, 2, 3, 7, 14, 21, 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| PCR Uncorrected ACPR at Day 28 Kaplan Meier analysis for recrudescence and new infections Proportion of patients with early and late treatment failure (ETF upto day 3 and LTF at Days 28 ) Proportion of aparasitemic patients on day 1, day 2 and day 3 Parasite clearance time. Fever clearance time. Gametocyte clearance time. Changes in level of cytokines (IL-2,IL-6,IL-10 and IFN ?)Timepoint: Day 0, 1, 2, 3, 7, 14, 21, 28 | — |
Countries
India
Contacts
Public ContactDr Praveen K Bharti
ICMR - National Institute of Malaria Research
Outcome results
None listed