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

NCT03391440 | Unknown Phase 4

• 1 other identifier: HS-10090-401
• Study Type: interventional
• Target: 469
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Inflammatory Disease

Outcome Measures

Primary Outcomes (1)

• Clinical cure Rate

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

  7-30 days

Secondary Outcomes (5)

• The incidence of AE

  14 days

• Incidence of ADR

  14 days

• Incidence of serious ADR

  14 days

• Bacteriological response（Bacterial elimination rate）

  the first day and 7-30 days

• PPK parameters

  14 days

Study Arms (1)

morinidazole

EXPERIMENTAL

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

Interventions

morinidazole DRUG

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)

morinidazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Interventions

morinidazole

Condition Hierarchy (Ancestors)

Pelvic Infection; Infections; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Shixuan Wang

CONTACT

02783663078

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: January 5, 2018
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 5, 2018

Record last verified: 2017-11

Locations

CN (1)