search
Back to results

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

Primary Purpose

Pelvic Inflammatory Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
morinidazole
Sponsored by
Jiangsu Hansoh Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Inflammatory Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

morinidazole

Arm Description

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)

Outcomes

Primary Outcome Measures

Clinical cure Rate
Clinical cure Rate （according to symptoms and signs） at 7-30 days post-therapy

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2017
Last Updated
December 29, 2017
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03391440
Brief Title
A Trial to Assess the Efficacy and Safety of Morinidazole in Women With Pelvic Inflammatory Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
469 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
morinidazole
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
morinidazole
Intervention Description
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)
Primary Outcome Measure Information:
Title
Clinical cure Rate
Description
Clinical cure Rate （according to symptoms and signs） at 7-30 days post-therapy
Time Frame
7-30 days
Secondary Outcome Measure Information:
Title
The incidence of AE
Description
The incidence of adverse events
Time Frame
14 days
Title
Incidence of ADR
Description
Incidence of adverse reactions
Time Frame
14 days
Title
Incidence of serious ADR
Description
Incidence of serious adverse reactions
Time Frame
14 days
Title
Bacteriological response（Bacterial elimination rate）
Description
Bacteriological response (on the first day post-therapy, at 7-30 days post-therapy)
Time Frame
the first day and 7-30 days
Title
PPK parameters
Description
Area under the plasma concentration versus time curve (AUC) of morinidazole
Time Frame
14 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shixuan Wang
Phone
02783663078
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shixuan Wang
Phone
027-83663078

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs