A Trial to Assess the Efficacy and Safety of Morinidazole in Women With Pelvic Inflammatory Disease

Study Overview
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Brief Summary
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To assess the efficacy, safety and Population Pharmacokinetic (PPK) of morinidazole and sodium chloride injection with levofloxacin hydrochloride and sodium chloride injection sequential of levofloxacin hydrochloride tablets in women with pelvic inflammatory disease: An Open-Lable Multicenter Prospective Non-Randomized Trial

Detailed Description
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Pelvic inflammatory disease (PID) is a spectrum of upper genital tract inflammations comprising endometritis, salpingitis, parametritis, oophoritis, tubo-ovarian abscess and/or pelvic peritonitis. The objectives of administering antimicrobial therapy in patients with PID are to control the symptoms and to prevent the late sequelae of the disease. Because anaerobe infections (e.g., Bacteroides fragilis infections) are associated with tubal and epithelial damage, anaerobic coverage is routinely recommended in women with pelvic infection. Guidelines have been developed in both the USA and Europe with regard to PID management. Metronidazole, a member of the nitroimidazole drug class, is included in the regimens recommended for improving anaerobic bacteria coverage. The sideeffects of metronidazole include a metallic taste, nausea, transient neutropenia, and peripheral neuropathy. Antimicrobial resistance to metronidazole has emerged after several decades of worldwide use of the drug. Morinidazole, a National Class I Antimicrobial, is a new type of third-generation nitroimidazole antimicrobial that is used for treating amoebiasis, trichomoniasis, and anaerobic bacterial infections, and which exhibits greater activity and less toxicity than metronidazole. Morinidazole and Sodium Chloride Injection used in PID or appendicitis cases had been approved by CFDA in 2014. This phase 4 study is to assess the efficacy, safety and Population Pharmacokinetic (PPK) of morinidazole in PID.

Official Title
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An Open-Lable Multicenter Prospective Non-Randomized Trial to Assess the Efficacy and Safety of Morinidazole With Levofloxacin and Sequential of Levofloxacin in Women With Pelvic Inflammatory Disease

Conditions
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Pelvic Inflammatory Disease

Intervention / Treatment
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* Drug: morinidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women between 18 and 65 years old patients with the diagnosis of PID: sexually active women or women have the risk of sexually transmitted infections, and lower abdominal pain symptoms, and lower abdominal tenderness, and adnexal and cervical motion tenderness on bimanual vaginal examination, and as well as at least one of the following signs: pyrexia (axillary temperature > 37.8 °C) mucopurulent cervical or vaginal discharge an elevated vaginal discharge white blood cell count (WBC) an elevated erythrocyte sedimentation rate an elevated C-reactive protein laboratory tests confirmed the presence of Chlamydia trachomatis infection in the cervix WBC > 10*109/L on routine blood examination Voluntary signing of written informed consent Exclusion Criteria: patients with a history of antibiotic therapy for more than 3 days patients with any condition likely to require surgery Cervical / vaginal discharge examination found Gonorrhea gonorrhea patients with an allergy to nitroimidazole or quinolones patients with brain and spinal cord lesions, epilepsy and various organ sclerosis patients who received an abortion or surgery of uterus, cervix, abdomen within 1 month serious chronic liver disease (Child-Pugh graded C-class) patients with hematopoietic dysfunction or chronic alcoholism any factors that increase the risk of QTc prolongation or arrhythmia ALT and / or AST ≥ 2 times the ULN serum creatinine ≥ 1.5 times the ULN total bilirubin ≥ 1.5 times the ULN ECG QTc interval> 470ms any clinically significant abnormalities in rhythms, conduction or morphology of resting ECGs Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: morinidazole<br>morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 14 days) with levofloxacin hydrochloride and sodium chloride injection (500 mg intravenous, once daily for the first week) sequential of levofloxacin hydrochloride tablets (500 mg (500 mg orally, once daily for the second week) | Drug: morinidazole<br>* morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 14 days) with levofloxacin hydrochloride and sodium chloride injection (500 mg intravenous, once daily for the first week) sequential of levofloxacin hydrochloride tablets (500 mg (500 mg orally, once daily for the second week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure Rate | Clinical cure Rate （according to symptoms and signs） at 7-30 days post-therapy | 7-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of AE | The incidence of adverse events | 14 days | 
| Incidence of ADR | Incidence of adverse reactions | 14 days | 
| Incidence of serious ADR | Incidence of serious adverse reactions | 14 days | 
| Bacteriological response（Bacterial elimination rate） | Bacteriological response (on the first day post-therapy, at 7-30 days post-therapy) | the first day and 7-30 days | 
| PPK parameters | Area under the plasma concentration versus time curve (AUC) of morinidazole | 14 days |