Gynecological pelvic inflammatory diseases (including endometritis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, pelvic peritonitis, parauterine connective tissue inflammation and others)
Conditions
Interventions
Test Group 1:Levornidazole Disodium Phosphate for Injection, intravenous drip, each 1g (4 tubes) of the test drug will bedissolved in 100mL of 0.9% sodium chloride injection. The first daily administr
the second administration is given with 100mL of 0.9% sodium chloride injection, each bottle drip time of 30-60 minutes, continuous administration for 7 days, each two infusions interval of 12 hours.
Test Group 2:Levornidazole Disodium Phosphate for Injection, intravenous drip, dissolved in 100mL of 0.9% sodium chloride injection per 1g (4 tubes) of the test drug. The first daily administration of
the second administration of 4 vials (dissolved in 100mL of 0.9% sodium chloride injection), each bottle drip time of 30-60 minutes, continuous administration for 7 days, each two infusions interval o
Control group:Levornidazole and Sodium Chloride Injection, intravenous drip, the first daily administration of 0.5g (100mL) is given, and another 100mL of 0.9% sodium chloride injection is given once
the second administration is given 0.5 g (100 mL) with a drip time of 30-60 minutes per vial for 7 consecutive days with an interval of 12 hours.
Sponsors
The First Affiliated Hospital With Nanjing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1)Female patients aged 18 to 65 (including patients aged 18 and 65); 2)Participants have not used effective anti-anaerobic drugs 72 hours before enrollment 3)Patients with gynecological pelvic infections caused by anaerobic bacteria that the investigators believe need to be treated with injection: sexually active women and STI (sexually transmitted infections) patients who meet the following conditions and have no other causes: a) uterine tenderness or adnexal tenderness or cervical motion tenderness; b) At least one of the following additional conditions is met: body temperature (axillary temperature) = 37.8°C, purulent cervical or vaginal discharge, leukocytosis detected by microscopic examination of vaginal discharge (15 per high-power white blood cell count =), Complete Blood Count white blood cell count = 10X10^9/L; C-reactive protein is elevated. 4) The subjects volunteered to be tested and signed the informed consent form, and the process of signing the informed consent form met the requirements of GCP.
Exclusion criteria
Exclusion criteria: 1) Patients who have known or suspected allergy to Nitroimidazoles; 2) Patients who have received clinical trials of other drugs within 3 months before screening or enrollment; 3) Patients who are taking other drugs or may interfere with the evaluation of drug safety or efficacy due to other diseases, or patients who are at risk of serious drug interactions due to concomitant medication (such as Warfarin, other antibiotics being effective against anaerobic bacteria, Levornidazole has contraindications to Furbencillin sodium, Nafcillin, Omeprazole, Omeprazolum, Potassium Sodium Dehydroandrograpolide Succinate for Injection, Azlocillin Sodium and others); 4) Patients who are considered by the investigator to have poor compliance and cannot complete the expected course of treatment and follow-up; 5) Abnormal liver function (ALT or AST > 1.5 times the upper limit of the reference value); abnormal renal function (serum creatinine exceeds the upper limit of the normal reference value); 6) The subject has severe cardiovascular and hematopoietic system diseases (such as heart failure, leukemia and others); 7) Pregnant and lactating women, (premenopausal) women of childbearing age with positive pregnancy test results before the test; female participants who did not have effective contraception or planned to conceive within 3 months; 8) Other patients deemed by the investigator to be unsuitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy after 14 days of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological efficacy and comprehensive efficacy after 14 days of treatment;Clinical efficacy, microbiological efficacy, and comprehensive efficacy of 7-day treatment; | — |
Countries
China
Contacts
Public ContactYilin Zheng
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed