JPRN-jRCTs071210114招募中2 期
Phase II clinical study for high-risk patients with chorioamnionitis using the integrated treatment of antibiotics
Miyamoto Shingo0 个研究点目标入组 24 人开始时间: 2022年1月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
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
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1) Patients diagnosed with preterm labor less than 34 weeks gestation.
- •2) Patients without obvious premature rupture of membrane.
- •3) Patients with sufficient major organ capacity.
- •4) The test value shall be within three months before the registration date.
- •(1) White blood cell count > 3,000 /mcl or neutrophil count > 1,000 /mcl
- •(2) Platelet count > 100,000 /mcl
- •(3) Hemoglobin > 8.0 g/dl
- •(4) AST, ALT < 100 IU/ml
- •(5) Serum creatinine < 1.0 mg/dl
- •(6) Serum bilirubin < 1.0 mg/dl
- •(7) Cardiac function (ECG) Patients without heart disease requiring treatment.
- •(8) Chest X-ray examination Patients without lung disease requiring treatment.
- •(9) D-Dimer < 4.0 mg/dl or Patients without obvious thrombus in deep veins in the leg by ultrasound test (> 4.0 mg/dl).
- •(10) PT < 15 sec.
- •(11) APTT 24-38 sec.
- •5) Patients aged 18 years or older at the time of consent acquisition.
- •6) Vaginal microbiome analysis: Patients diagnosed positive with a PCAM score or modified PCAM score (modified scoring method by self-learning) by rapid next-generation sequencing.
- •7) Patients with 16S rDNA levels not exceeding 10e-6 copies/ml in amniotic fluid.
排除标准
- •1) Patients with body temperature of 38 degree celsius or higher at rest.
- •2) Patients with a heart rate of 120 /min or higher and a white blood cell count of 20,000 /mcl or higher.
- •3) Patients diagnosed with clinical chorioamnionitis according to the diagnostic criteria of Lencki et al.
- •4) When there is maternal fever (> 38 degree celsius) (1) Maternal tachycardia (> 100 bpm) (2) Uterine tenderness (3) Vaginal discharge / amniotic fluid malodor (4) Leukocytosis (> 15,000 /mcl), there must be at least one item in four items (1-4). Alternatively, there must be all four items from (1) to (4) if there is no maternal fever (> 38 degree celsius).
- •5) Patients with psychiatric disorders requiring treatment.
- •6) Patients with uncontrolled diabetes.
- •7) Patients with active or uncontrollable infections.
- •8) Patients with a history of severe drug hypersensitivity.
- •9) Patients with malignant tumors requiring treatment and with a history of malignant tumors within five years (excluding intraepithelial neoplasia).
- •10) Patients with cancer or receiving chemotherapy, radiation therapy, or other cancer therapies.
- •11) Patients with serious complications (heart disease, lung disease, liver disease, renal disease, bleeding tendency, sepsis, uncontrolled diabetes, uncontrolled hypertension, preeclampsia, etc.)
- •12) Infectious disease (hepatitis B, hepatitis C, HIV, syphilis) positive and active patients.
- •13) Patients with a history of drug hypersensitivity to azithromycin or meropenem.
- •14) Patients encountered when rapid next-generation sequence analysis or droplet digital PCR does not work (sometimes excluded after enrollment).
- •15) Other, patients who the principal investigator or coordinator deems inappropriate.
研究者
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