ISRCTN45944555进行中（未招募）3 期
Evaluation of point of care digital molecular diagnostic tool in malaria chemoprevention in pregnant women in the context of parasite resistance to sulphadoxine-pyrimethamine in a malaria high transmission area of Nchelenge in Zambia
Tropical Diseases Research Centre0 个研究点目标入组 254 人开始时间: 2024年4月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 254
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
- 性别
- Female
入选标准
- •1. Gestational age of 16 to 26 weeks at enrolment
- •2. Asymptomatic* on presentation
- •3. Hb = 7 g/dL
- •4. HIV negative at enrolment
- •5. No history of IPTp-SP or antimalarial drug use during the current pregnancy
- •6. At least 15 years old
- •7. Residence within the health facility catchment area
- •8. Willing to deliver at the health facility
- •9. Willing to adhere to the study requirements (HIV voluntary counseling and testing (VCT included)
- •10. Ability to provide written informed consent; if the woman is a minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law
- •(* Asymptomatic defined as the absence of fever (temperature <37.5 °C) at baseline; less than three of the following symptoms: fever in the past 24 h, weakness/fatigue; muscle and/or joint aches, headache. An assent will also be obtained from the participant).
排除标准
- •1. HIV positive or unknown at enrolment
- •2. Hb<7 g/dl
- •3. History of allergic reactions to the study drugs
- •4. History of known pregnancy complications or bad obstetric history including pre-existing illness likely to cause complication of pregnancy such as repeated abortions, stillbirths or eclampsia
- •5. History or presence of major illnesses likely to influence pregnancy outcome including hypertension, diabetes mellitus, asthma, epilepsy, renal disease, liver disease, fistula repair, heart disease, or active tuberculosis
- •6. Current cotrimoxazole prophylaxis or ARV treatment
- •7. Any significant illness at the time of screening that requires hospitalization, including severe malaria
- •8. Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment area
- •9. Prior enrolment in the study or concurrent enrolment in another study
- •10. Unable to take oral medication
- •11. Clear evidence of recent (2 weeks) treatment with antimicrobials with antimalarial activity (clindamycin, azithromycin, clarithromycin, levofloxacin etc.)
- •12. On at least one of the following drugs: Pentamidine, Antiarrhythmic agents (e.g., amiodarone, sotalol), Antihistamines (e.g., promethazine), Antifungals (systemic): ketoconazole, fluconazole, itraconazole, Diuretics (e.g., hydrochlorothiazide, furosemide), Antipsychotics (neuroleptics): haloperidol, thioridazine, Antidepressants: imipramine, citalopram, escitalopram, Antiemetics: domperidone, chlorpromazine, ondansetron
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