NCT01103063终止3 期
A Phase 3, Open Label, Randomized, Comparative Study To Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 2,891
- 试验地点
- 9
- 主要终点
- Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
研究概览
简要总结
The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
详细描述
After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by ultrasound).
- •Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age.
- •Subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Subjects who are available for follow up at delivery and on 28 days post delivery.
排除标准
- •Age <16 years old or >35 years old.
- •Multiple gestations as per the ultrasound at screening.
- •Clinical symptoms of malaria.
- •Hemoglobin < 8 g/dL (at enrollment).
- •Any condition requiring hospitalization at enrollment.
- •History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability.
- •Inability to tolerate oral treatment in tablet form.
- •Known allergy to the study drugs (azithromycin, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.
- •Requirement to use medication during the study that might interfere with the evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
- •Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
- •Known severe Sickle Cell (SS) disease or Sickle Hemoglobin C (SC) anemia.
- •Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death.
研究组 & 干预措施
AZCQ
Experimental
Azithromycin/chloroquine
干预措施: Azithromycin plus chloroquine (Drug)
SP
Active Comparator
sulfadoxine-pyrimethamine (Fansidar)
干预措施: sulfadoxine-pyrimethamine (Drug)
结局指标
主要结局
Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
时间窗: Approximately 40 weeks of gestational age
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (\<2,500 g), premature births (\<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (\>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
次要结局
- Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population(Approximately 40 weeks of gestational age)
- Percentage of Neonates With LBW (<2500 g) in ITT Population(Approximately 40 weeks of gestational age)
- Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population(Approximately 40 weeks of gestational age)
- Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation(At 36-38 weeks of gestation.)
- Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation(At 36-38 weeks of gestation.)
- Percentage of Participants With Placental Parasitemia at Delivery(Approximately 40 weeks of gestational age)
- Percentage of Participants With Placental Malaria at Delivery Based on Histology(Approximately 40 weeks of gestational age)
- Sexually Transmitted Infection (STI) Episodes Per Participant(Approximately 40 weeks of gestational age .)
- Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation(Approximately 40 weeks of gestational age.)
- Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.(Baseline, at 36-38 weeks of gestation.)
- Percentage of Perinatal or Neonatal Deaths(Day 28 after delivery.)
- Birth Weight of Live Borne Neonate(Approximately 40 weeks of gestational age.)
- Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation(At 36-38 weeks of gestation)
- Percentage of Participants With Peripheral Parasitemia at Delivery(Approximately 40 weeks of gestational age)
- Percentage of Participants With Cord Blood Parasitemia at Delivery(Approximately 40 weeks of gestational age)
- Percentage of Neonates With Congenital Abnormalities at Birth(Approximately 40 weeks of gestational age.)
- Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery(Approximately 40 weeks of gestational age)
- Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation(At 36-38 weeks of gestation)
- Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation(At 36-38 weeks of gestation)
- Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery(Approximately 40 weeks of gestational age)
- Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation(Upto 36-38 weeks of gestation)
- Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation(At 36-38 weeks of gestation)
- Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.(At 36-38 weeks of gestation)
- Percentage of Neonates With Ophthalmia Neonatorum at Birth Period(Approximately 40 weeks of gestational age)
- Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery(Up to approximately 40 weeks of gestational age)
- Percentage of Participants With Pre-eclampsia From Week 20 to Delivery(From Week 20 to approximately 40 weeks of gestational age)
- Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae(Visits 6 and 7)
- Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae(Visits 6 and 7)
- Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation(At 36-38 weeks of gestation)
研究者
研究点 (9)
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