CTRI/2011/11/002129已完成3 期
A phase III, open label, randomized, parallel group, multicentric trial comparing the safety and efficacy of fixed dose combination tablets of arterolane maleate and piperaquine phosphate (PQP) with chloroquine tablets in patients with acute uncomplicated Plasmodium vivax malaria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 316
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 <18 years, wherever feasible to the extent of the patient?s capabilities willing to provide informed assent and their parent/legal acceptable representative willing to provide informed consent.
- •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
排除标准
- •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:
- •?XSerum creatinine 1.5 ¡Ñ upper limit of normal (ULN)
- •?XAspartate transaminase 2.5 ¡Ñ ULN
- •?XAlanine transaminase 2.5 ¡Ñ ULN
- •?XSerum 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
研究者
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