EUCTR2014-004906-14-Outside-EU/EEA进行中（未招募）不适用
An Open Label, Non-Comparative Study To Evaluate Parasitological Clearance Rates and Pharmacokinetics of Azithromycin and Chloroquine Following Administration of a Fixed Dose Combination of Azithromycin and Chloroquine (AZCQ) in Asymptomatic Pregnant Women With Plasmodium Falciparum Parasitemia in Sub-Saharan Africa
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Primigravidae and secundigravidae pregnant women at greater than or equal to (>=) 14 and less than or equal to (<=) 30 weeks of gestational age (confirmed by ultrasound examination).
- •2. Evidence of asymptomatic parasitemia with Plasmodium falciparum monoinfection (confirmed by microscopy) with parasite counts in the range of 80-100,000 per microliter on thick blood smears.
- •3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if a subject is less than [<] 18 years of age) has been informed of all pertinent aspects of the study and that all questions by the subject have been sufficiently answered. Assent will be obtained from subjects <18 years of age.
- •4. Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •5. Subjects supervised for treatment administration, and available for all follow up visits as per protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 168
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 127
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age <16 years old or greater than (>)35 years old.
- •2. Multiple gestations (more than one fetus) as per the ultrasound results at screening.
- •3. Clinical symptoms of malaria.
- •4. Hemoglobin <8 gram per deciliter (g/dL).
- •5. Any condition requiring hospitalization or evidence of severe concomitant infection at time of presentation.
- •6. Use of antimalarial drugs in previous 4 weeks.
- •7. History of convulsions, hypertension, diabetes or any other chronic illness that may
- •adversely affect fetal growth and viability.
- •8. Inability to tolerate oral treatment in tablet form.
- •9. Known allergy to the study drugs (Azithromycin [AZ], Chloroquine [CQ], and Sulfadoxine-pyrimethamine [SP]) or to any macrolides or sulphonamides.
- •10. Present history of smoking or alcohol or drug abuse since becoming pregnant.
- •11. Participation in other studies within 30 days before the current study begins and/or during study participation.
- •12. Inability to comprehend and/or unwillingness to follow the study protocol.
- •13. Concurrent participation in another investigational study.
- •14. Previously randomized in this study.
- •15. Requirement to use medication during the study that might interfere with the evaluation of the study drug (for example, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection) or is contra-indicated during pregnancy per package inserts.
- •16. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that increase the risk associated with study participation or investigational product administration or interfer with the interpretation of study results and, made the subject inappropriate for entry into this study
- •17. Evidence of current obstetric complications that adversely impacted the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
- •18. Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.
- •19. Known family history of prolonged QT syndrome, serious ventricular arrhythmia, or sudden cardiac death.
研究者
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