Health Condition 1: null- Acute uncomplicated Plasmodium vivax malaria
Conditions
Interventions
Intervention1: Fixed Dose Combination(FDC) tablets of arterolane
maleate 150 mg and PQP 750 mg of Ranbaxy
Laboratories Limited, India
: Total 3 doses to be given to patients. Single tablet of FDC of
Second dose and Third dose to be given 24(+/- 4)hrs and 48(+/- 4)hrs respectively with respect to the First dose administration
To be administered by Oral route over 3 consecutive days
Control Intervention1: Chloroquine tablets of Bayer: Total 4 doses to be administered to a single patient. A total dose of 2.5 g chloroquine ph
each tablet containing 250 mg of chloroquine phosphate USP, equivalent to 150 mg of chloroquine base
Second dose, Third dose and Fourth dose to be administered at 6(+2), 24(+/-4) and 48(+/-4)hrs respectively with respect to First dose administration.
To be administered by oral route over 3 consecuti
Sponsors
Ranbaxy Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients must fulfill the following inclusion criteria to be eligible for enrollment into the study: 1. Body weight must be > 40 kg at screening. 2. Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. vivax parasites only. 3. Parasite density appropriate for inclusion will be > 250/ µL of blood. 4. Presence of fever (axillary temperature ≥ 37.5 °C or oral ≥ 38 °C) or history of fever in the past 48 hours. 5. Female patients, if of child-bearing potential must be non-lactating and willing to use contraceptive methods during the study period. 6. Patients willing to give informed consent. Patients 7. Willingness and ability to comply with the study protocol for the duration of the study. 8. 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. Patients with severe malaria as per WHO criteria 1, 17 (Appendix B). 2. Mixed infection with another Plasmodium species at the time of presentation (including P. falciparum, P. ovale and P. malariae). 3. Hemoglobin (Hb) level of 8 gm/dL. 4. Past history of hemolytic anaemia or methemoglobinemia. 5. A female patient who is lactating or pregnant at screening. 6. Known allergy to artesunate, artemisinin derived products, piperaquine, chloroquine, primaquine or any other related drugs. 7. 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). 8. Use of concomitant medications that may induce haemolysis or haemolytic anaemia or depressants of myeloid element of the bone marrow. 9. Any antimalarial treatment during 1 month prior to screening, as assessed by medical history. 10. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole. 11. Participation in any investigational drug study at least 3 months prior to screening. 12. 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). 13. 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. 14. Patients with known significant renal or hepatic impairment indicated by the following laboratory evaluations at screening: ?X Serum creatinine 1.5 ¡Ñ upper limit of normal (ULN) ?X Aspartate transaminase 2.5 ¡Ñ ULN ?X Alanine transaminase 2.5 ¡Ñ ULN ?X 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) that may compromise the diagnosis and the evaluation of the response to the study medication. 18. Patients who have epilepsy or a history of convulsions. 19. Patients who are G6PD deficient indicated by laboratory investigation at screening. 20. Any retinal/ visual field defects or auditory defects, of any etiology assessed on the basis of history. . 21. Patients with psoriasis and porphyria assessed on the basis of history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of aparasitemic and afebrile patients at 72 hoursTimepoint: 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Cure rateTimepoint: Day 28;Fever clearance time (FCT)Timepoint: Hours;Parasite clearance time (PCT)Timepoint: Hours | — |
Countries
India
Contacts
Public ContactSanjukta Bhattacharyya
Ranbaxy Laboratories Limited
Outcome results
None listed