Health Condition 1: null- Acute uncomplicated P.vivax malaria in pediatric patients
Conditions
Interventions
Intervention1: FDC of arterolane maleate and piperaquine phosphate dispersible oral formulation: The study drug FDC of arterolane maleate 37.5 mg + Piperaquine phosphate 187.5 mg dispersible tablet wi
2 years to 6 years: 2 tabs
6 years to 12 years: 3 tabs
Intervention2: Primaquine dispersible tablets: Dispersible tablets of primaquine phosphate equivalent to 2.5 mg base for oral administration shall be provided to the study
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients must fulfil the following inclusion criteria to be eligible for enrolment into the study: 1. Children of either sex (male or female) aged between 6 months to 12 years (both inclusive). 2. Parent/Guardian/LAR willing to undergo audio visual recording of the consent process and provide a written informed consent by parent/guardian/LAR. If parent/guardian/LAR is unable to provide informed consent in writing, a thumbprint on informed consent document to indicate consent in the presence of at least one witness is acceptable. 3. Minimum body weight of 5 kg. 4. Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. vivax parasites >=250/ µL of blood. 5. Absence of acute severe malnutrition (defined as weight-for-height below -3 standard deviation of WHO normalized reference values and mid-upper arm circumference 6. Able to take drugs under study by the oral route 7. Minimum Haemoglobin (Hb) level of >8 gm/dL. 8. Presence of fever (axillary temperature >=37.5 °C or oral >=38 °C) or a history of fever in the past 24 hours. 9. Willingness and ability to comply with the study protocol for the duration of the study.
Exclusion criteria
Exclusion criteria: If any of the following conditions apply, the patient should not be enrolled in the study. 1. Known allergy to arterolane maleate, artesunate, artemisinin derived products, piperaquine, chloroquine, primaquine, excipients of these drugs or any other related drugs. 2. Patients with severe malaria as per WHO criteria. 3. Presence of general danger signs of severe malaria among children 5 years old (as per WHO) 4. Mixed infection with another Plasmodium species at the time of presentation (including P. falciparum, P. ovale and P. malariae). 5. Infants with a history of hyperbilirubinemia during the neonatal period. 6. Patients with history of hemolytic anaemia or methemoglobinemia. 7. Use of concomitant medications that may induce haemolysis or haemolytic anaemia or depressants of myeloid element of the bone marrow. 8. Any antimalarial treatment during 1 month prior to screening, as assessed by medical history. 9. Gastrointestinal dysfunction that could alter absorption or motility (e.g., diarrhea 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). 10. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole, doxycycline & malarone. 11. Patients with significant disease(s), disorder(s) other than malaria that in the opinion of the Investigator may (i) put the patient at risk because of participation in the study or (ii) interfere with the study evaluations or (iii) cause concern regarding patientsâ?? ability to participate in the study. 12. Electrocardiogram (ECG) abnormalities with clinical significance or relevance that require urgent management, including QTc interval 450 msec at screening and cardiac conduction disorders, with the exception of right bundle branch block. 13. Patients with known significant renal or hepatic impairment or electrolyte imbalance indicated by any of the following laboratory evaluations at screening: • Serum creatinine 1.5 Ã? upper limit of normal (ULN) • Aspartate transaminase 2.5 Ã? ULN • Alanine transaminase 2.5 Ã? ULN • Serum bilirubin 3 mg/dL • Serum potassium Lower limit of Normal (LLN) • Serum Sodium LLN 14. Patients who have had a splenectomy as confirmed by history or clinical examination. 15. Patients who are G6PD deficient indicated by laboratory investigation at screening. 16. Patients with history of any retinal/ visual field defects or auditory defects of any etiology assessed on the basis of history. 17. Patients with psoriasis and porphyria assessed on the basis of history. 18. Patients taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (flecainide, metoprolol, imipramine, amitriptyline, clomipramine, etc) 19. Participation in any investigational drug study at least 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of aparasitemic and afebrile patients at 72 hoursTimepoint: Proportion of aparasitemic and afebrile patients at 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Cure rate on Day 28 Parasite Clearance Time (PCT) Fever Clearance Time (FCT) Cure rate at Day 42 Safety endpoints: Incidence of adverse events or clinically significant changes in laboratory parameters, physical examination, ECG, vital signsTimepoint: Parasitology and body temperature at screening, predose day 0 and at 6 hour intervals, 72 hours, Day of Discharge (if patient is discharged â?¥ 6 hr post 72 hr time point), 7(±1), 14(±1), 28(±1) and 42(±1) / end of study. Laboratory assessment at Screening, Day 2, 7(±1), 28(±1) and 42(±1). ECG at screening, between 2 and 4 hours after the 3rd dose. Vitals at screening, days 1, 2, 3, 7(±1), 14(±1), 28(±1) and 42(±1). | — |
Countries
India
Contacts
Public ContactDr Amit Nasa
Sun Pharmaceutical Industries Ltd
Outcome results
None listed