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

Pelvic Inflammatory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391440
• Other study ID #: HS-10090-401
• Status: Recruiting
• Phase: Phase 4
• First received: November 28, 2017
• Last updated: December 29, 2017
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Shixuan Wang
• Phone: 02783663078
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 469
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• women between 18 and 65 years old

• patients with the diagnosis of PID:

1. sexually active women or women have the risk of sexually transmitted infections, and

2. lower abdominal pain symptoms, and

3. lower abdominal tenderness, and adnexal and cervical motion tenderness on bimanual vaginal examination, and

4. as well as at least one of the following signs:

1. pyrexia (axillary temperature > 37.8 °C)

2. mucopurulent cervical or vaginal discharge

3. an elevated vaginal discharge white blood cell count (WBC)

4. an elevated erythrocyte sedimentation rate

5. an elevated C-reactive protein

6. laboratory tests confirmed the presence of Chlamydia trachomatis infection in the cervix

7. WBC > 10*109/L on routine blood examination

5. 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

Related Conditions & MeSH terms

• Pelvic Inflammatory Disease

Intervention

Drug:
• morinidazole
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)

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure Rate	Clinical cure Rate (according to symptoms and signs) at 7-30 days post-therapy	7-30 days
Secondary	The incidence of AE	The incidence of adverse events	14 days
Secondary	Incidence of ADR	Incidence of adverse reactions	14 days
Secondary	Incidence of serious ADR	Incidence of serious adverse reactions	14 days
Secondary	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
Secondary	PPK parameters	Area under the plasma concentration versus time curve (AUC) of morinidazole	14 days