Health Condition 1: null- acute uncomplicated P.falciparum malaria in pediatric patients
Conditions
Interventions
Intervention1: FDC of arterolane maleate and piperaquine phosphate dispersible formulation: Arterolane maleate 37.5 mg and piperaquine phosphate 187.5 mg
Investigational drug product will be administ
2 yrs to 6yrs :2 tablets
6 yrs to â?¤12yrs:3 tablets
Control Intervention1: Coartem Dispersible tablets: Coartem® dispersible (artemether 20mg and lumefantrine 120mg)
A 3-day treatment schedule with a total of 6 oral doses
15 to 25kg : 2 tablets
25 to 35kg : 3 tablets
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients must fulfil the following inclusion criteria to be eligible for enrolment into the study: 1.Children of either gender (male or female) aged between 6 months to 12 years, both inclusive. 2.Minimum body weight of 5 kg. 3.Able to take drugs under study by the oral route 4.Absence of severe malnutrition (defined as a child who has symmetrical oedema involving at least the feet and whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/ WHO normalized reference values or mid-upper arm circumference 5.Minimum Hemoglobin (Hb) level of > 8 gm/dL. 6.Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum parasites only. 7.Initial parasite densities appropriate for inclusion will be between 1,000 and 100,000 asexual parasites/μL blood (both inclusive). 8.Presence of fever (axillary temperature >= 37.5 °C) or a history of fever in the past 24 hours. 9.Written informed consent, provided by parent/guardian. If parent/guardian is unable to provide informed consent in writing, a thumbprint to indicate consent in the presence of at least one witness is acceptable. 10.Willingness and ability to comply with the study protocol for the duration of the study. 11.Patient resides within a reasonable distance of the investigational site, so that attendance of all study visits and follow-up by medical staff are logistically feasible.
Exclusion criteria
Exclusion criteria: If any of the following conditions apply, the patient should not be enrolled in the study. 1.Known allergy to artesunate, artemether, artemisinin derived products, piperaquine or any other related drug. 2.Infants with a history of hyperbilirubinemia during the neonatal period. 3.Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the World Health Organization (WHO) list of essential drugs. 4.Evidence of any concomitant infection at the time of presentation (including P. vivax, P. ovale and P. malariae). 5.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). 6.Patients with severe malaria as per WHO criteria. 7.Presence of general danger signs of severe malaria among children 5 years old (as per WHO). 8.Female patients between the age group of 8 to 12 years (both inclusive) who are pregnant at screening. The selection of the candidate for pregnancy screening test would be as per the judgment of the Investigator. 9.Female patients between the age group of 8 to 12 years who are lactating at the time of screening. 10.Any antimalarial treatment during 1 month prior to screening, as assessed by medical history. 11.Participation in any investigational drug study during the 30 days prior to screening. 12.Electrocardiogram (ECG) abnormalities with clinical significance or relevance that require urgent management. These abnormalities include QTc interval 450 msec at screening and cardiac conduction disorders, with the exception of right bundle branch block. 13.Gastrointestinal dysfunction that could alter absorption or motility (e.g., diarrhoea defined as 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). 14.Patients with known significant renal or hepatic impairment indicated by the following laboratory evaluations at screening: Serum creatinine 1.5Ã?upper limit of normal (ULN). Aspartate transaminase 2.5 Ã? ULN. Alanine transaminase 2.5 Ã? ULN. Serum bilirubin 3 mg/dL. 15.Patients who have had a splenectomy as confirmed by history or clinical examination. 16.Patients with known history of human immunodeficiency virus (HIV) infection or other immunosuppressive disorders. 17.Evidence of clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied). 18.Patients taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (flecainide, metoprolol, imipramine, amitriptyline, clomipramine, etc) 19.With known disturbances of electrolyte balance at screening: Serum potassium LLN Serum Sodium LLN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 28 PCR corrected ACPRTimepoint: Day 28 PCR corrected ACPR | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Median parasite clearance time (time to reach 100% clearance) (PCT). â?¢Fever clearance time (FCT). â?¢Proportion of patients with PCR-uncorrected ACPR on Day 28 and Day 42. â?¢Safety endpoints: Incidence of adverse events or clinically significant changes in laboratory parameters, physical examination, ECG, or vital signs. Timepoint: parasitology and body temperature at 6 hour intervals, discharge/ Day 3, on follow-up Days 7 (±1), 14(±1), 28(±1) and 42(±1) Laboratory assessment Day 2, Day 28(±1) and Day 42(±1) ECG screening, and Day 2 between 2 and 4 hrs Vital signs Days 1, 2, 3, 7(±1), 14(±1), 28(±1) and 42(±1) | — |
Countries
Cote d'Ivoire, Democratic Republic of the Congo, India, Malawi, Mali, Mozambique, Rwanda, Senegal
Contacts
Public ContactDr Rajinder K Jalali
Sun Pharmaceutical Industries Ltd
Outcome results
None listed