CTRI/2022/12/048283招募中3 期
A multi-center randomized controlled trial to compare the efficacy, safety, and tolerability of high dose, short course Primaquine–A pilot study
ICMR National Institute of Malaria Research0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
- •1.P. vivax (asexual) malaria monoinfection confirmed by microscopy on a thin and thick blood smear
- •2.Age 16 years and over of either gender.
- •3.Fever > 37.5°C axillary, or a history of fever within 48 hours
- •4.Female patients of child-bearing potential are included if they are non-lactating and willing to use contraceptive methods during the study period. Non-child bearing potential defined as:
- •4.1 post-menopausal (12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL), pre-menopausal and has had a hysterectomy or a bilateral oophorectomy (removal of the ovaries) or a bilateral tubal ligation with medical report verification or,
- •4.2 Child-bearing potential, has a negative urine pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 90 days after stopping study drug:
- •4.2.1 Use of oral contraceptive, either combined or progesterone alone (if no contraindications to oral contraceptives exist).
- •4.2.2 Barrier contraceptive if oral contraceptives are contraindicated
- •4.2.3 Use of an intrauterine device.
- •5.Willing to give informed consent.
- •6.Willing to comply with protocol instructions and duration of follow up.
- •7.Only patients living in and around the site facilities will be enrolled in the study to facilitate follow-up.
排除标准
- •1.Patients with G6PD activity less than 30% of the adjusted male median (AMM), tested by UV spectrophotometry.
- •2.Patients with mixed infection with P. vivax and P. falciparum (e.g. identified by Giemsa-stained smear or rapid diagnostic test).
- •3.Patient with body weight less than 40 kg.
- •4.Severe P. vivax malaria defined as per Indian National Guidelines criteria (Appendix I).
- •5.Haemoglobin <8 g/dl to be measured by Hb auto analyser.
- •6.Cannot tolerate oral treatment
- •7.History of haemolytic anaemia or methemoglobinemia or blood transfusion within 90 days
- •8.Pregnant and lactating females.
- •9.Known allergy to chloroquine, primaquine or any other related drugs.
- •10.Evidence of gastro-intestinal dysfunction that could alter absorption or motility (e.g., diarrhoea defined as >3 episodes of watery stools in the previous 24 h or patients who have had three episodes of vomiting within 24 h prior to screening).
- •11.Use of concomitant medications that could induce haemolysis or haemolytic anaemia or depressants of myeloid element of the bone marrow.
- •12.Any anti-malarial treatment taken 1 month prior to enrolment.
- •13.Ongoing prophylaxis with drugs having anti-malarial activity
- •14.Participation in any other investigational drug study of at least 3 months prior to screening
- •15.Any other underlying disease that could compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, HIV, Hepatitis, tuberculosis, Splenectomy conducted earlier as confirmed by history or clinical examination; evidence of clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine diseases, malignancy, or other abnormalities.
- •16.Retinal/visual field defects or auditory defects and history of psoriasis and porphyria.
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