Comparative Evaluation of Efficacy and Safety of Primaquine SR Tablets Vs Primaquine Conventional Tablets in the Prevention of Relapse of Plasmodium Vivax Malaria.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 10
- 主要终点
- No occurrence of microscopically proven P. vivax malaria (asexual forms) after treatment with primaquine.
研究概览
简要总结
This study is a randomized, double blind, parallel group, multicentre trial comparing the efficacy and safety of primaquine-Sr tablet and primaquine conventional release tablets in the preventiona of relapse P.vivax malaria in 360 patients that will be conducted at 7 centres in India. The primary efficacy outcome will be no occurenece of asexual forms of parasites in the blood 6 months after primaquine therapy. Secondary outcome will be occurence of parasites with syptoms of malaria after six months of primaquine therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
入选标准
- •1.Male and female patients aged 18 -65 years.2.Patients with confirmed cases of P.
- •vivax malaria (asexual forms) by microscopy on a thin and thick blood smear with parasite count of >/=1,000/µL of blood.3.Patients with axillary temperature >/= 37.5 °C and with clinical signs and symptoms of malaria.
- •Patients giving written informed consent to participate in this study.5.patients willing to undergo folloe-up for 2-6 months.
排除标准
- •Patients with Mixed malarial infection.
- •2.Patients with body weight 40 kg.
- •3.Patients with severe or complicated malaria.
- •4.Patients with glucose 6-phosphate dehydrogenase deficiency.
- •5.Patients with a history of dark urine or significant hemoglobinuria related to Primaquine treatment during the course of a pervious episode of malaria.
- •6.Patient with known history of methomoglobinemia.
- •7.Patients taking cardioactive drug or potentially hemolytic drugs.
- •8.Patients with concomitant illness (cardiac, hepatic or renal diseases-blood urea nitrogen (BUN) 20mg/dl or blood urea 40mg/dl, hepatic SGPT or SGOT 2.5 x ULN, serum bilirubin 2mg/dl and serum creatinine 1.5mg/dl)).
- •Patients previously treated with any other antimalarial therapy except chloroquine.
- •10.Patients showing any significant abnormality (clinical or laboratory) on pre-trial screening in the opinion of the investigator.
- •Patients with protracted vomiting and oliguria.
- •12.Patients with systolic BP 160 mm Hg and/or diastolic BP 110 mm Hg. 13.Patients with acute exacerbations of systemic diseases, having a tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus.
- •15.Patients with history of hypersensitivity to chloroquine, primaquine or aminoquinoline derivatives, or other similar drugs.
- •Patient having any concomitant medication which may interact with study drugs.
- •17.Patients on another investigational drug.
- •Patients unable to tolerate oral medication and known history of alcoholism.
- •19.Pregnant or lactating women.
结局指标
主要结局
No occurrence of microscopically proven P. vivax malaria (asexual forms) after treatment with primaquine.
时间窗: Parasite count will be measured every 12 hours during 3 days of chloroquine therapy untill negative and then on day 7, 14, 21, 28 and then monthly up to 6 months. After day 14 parasite count will be measured only if the clinical signs and syptoms of malaria are present.
次要结局
- Comparative safety(At the end of therapy on day 14)