Health Condition 1: null- Acute Uncomplicated Plasmodium falciparum malaria
Conditions
Interventions
Intervention1: Fixed dose combination (FDC) tablets of arterolane maleate 150 mg and PQP 750 mg of Ranbaxy Laboratories Limited, India for oral administration: once daily for three days
Control Interv
Sponsors
Ranbaxy Laboratories Ltd
Department of Science and Tecnology Govt Of India
Eligibility
Inclusion criteria
Inclusion criteria: Patients must fulfill the following inclusion criteria to be eligible for enrollment into the study: 1. M/F patients b/w age of 12 to 65 (Both incusive) 2. B/w more than or equal to 35 kg at screening 3. presence of acute symptomatic uncomplicated malaria with confirmed diagnosis by blood smear with asexual forms of P. falciparum parasites only. 4. asexual parasites/µL in blood in patients b/w 1,000 and 100,000 (both inclusive) 5. presence of fever (axillary temperature &#8805; 37.5 °C or oral &#8805; 38 °C) or a documented history of fever in the past 24 hours 6. Female patients, if of child-bearing potential must be non-lactating and willing to use contraceptive methods during the study period 7. Written informed consent, provided by patient in accordance with local practice. If a patient is unable to provide informed consent in writing, a thumbprint to indicate consent in the presence of at least one witness is acceptable. For adolescents written informed consent, in accordance with local practice, provided by parent/guardian. If the parent/guardian is unable to write, thumb print witnessed consent is permitted. For patients < 18 yrs, wherever feasible, assent will also be obtained
Exclusion criteria
Exclusion criteria: If any of the following conditions apply, the patient should not be enrolled in the study. 1. Patients with severe malaria as per WHO criteria1 (Appendix B). 2. Mixed infection with another Plasmodium species at the time of presentation (including P. vivax, P. ovale and P. malariae). 3. Hemoglobin (Hb) level of 8 gm/dL. 4. A female patient who is lactating or pregnant at screening. 5. Known allergy to artesunate, artemether, artemisinin derived products, lumefanterine, piperaquine or any other related drug. 6. 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). 7. Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the World Health Organization (WHO) list of essential drugs. 8. Any antimalarial treatment during 1 month prior to screening, as assessed by medical history. 9. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocystis carini pneumonia in children born to HIV+ women. 10. Participation in any investigational drug study during the 30 days prior to screening. 11. 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). 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. Patients with known significant renal or hepatic impairment indicated by 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 14. Patients who have had a splenectomy as confirmed by history or clinical examination. 15. Patients with known history of human immunodeficiency virus (HIV) infection or other immunosuppressive disorders. 16. Evidence of clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied) that may compromise the diagnosis and the evaluation of the response to the study medication. 17. Patients who have epilepsy or a history of convulsions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with PCR corrected ACPRTimepoint: On Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Fever Clearance Time (FCT)Timepoint: time from first dosing to first normal reading of temperature (37.5 C) for 2 consecutive normal temperature readings and a confirmed normal temperature 24 hours after the first normal body temperature reading;Number of gametocytesTimepoint: Days 0,1,2,3,7,14,21,28,35 and 42;Parasite Clearance Time (PCT)Timepoint: Time in hours from initiation of therapy until first of the two consecutive negative smears are obtained;Pk parameters: Cmax, Tmax, AUC, CL/F, Vd/F, t1/2 and additional PK model dependant parameterTimepoint: Days 0,1,2,7,14,21,28,35 and 42;Proportion of aparasitemic patientsTimepoint: Days 1, 2 and 3;Proportion of patients with PCR corrected ACPRTimepoint: Day 42;Proportion of patients with PCR-uncorrected ACPRTimepoint: Day 28;Proportion of patients with PCR-uncorrected ACPRTimepoint: Day 42;safety endpoints: Incidence of adverse events, lab parameters, physical examination, ECG or vitalsTimepoint: Days 0,1,2,3,7,14,21,28,35 and 42 | — |
Countries
Cote d'Ivoire, Democratic Republic of the Congo, India, Mali, Mozambique, Senegal, Thailand
Contacts
Public ContactDr Nilanjan Saha
Ranbaxy Laboratories Limited
Outcome results
None listed