Comparative study of conventional and new treatments for patients with intrauterine infections

JRCT ID: jRCTs071210114

Registered date:19/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Preterm labor
• Date of first enrollment: 19/01/2022
• Target sample size: 24
• Study type: Interventional

Intervention(s)

1) AZM group: Azithromycin: 1 g / day (3 times every 7 days).
2) AZM + MEPM group: Azithromycin: 1 g / day (3 times every 7 days) and meropenem: 1 g x 3 / day - 14 days continuous administration.

Outcome(s)

• Primary Outcome: Amounts of bacteria in amniotic fluid (16S rDNA copy numbers per 1 mL of amniotic fluid)
• Secondary Outcome: Safety, Efficacy, Extended period of pregnancy, Inflammation findings of placenta, Changes in bacterial composition of vaginal bacterial flora, Genetic testing with NGS for MRSA in the maternal nasal cavity, Clinical prognosis of newborns

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Miyamoto Shingo