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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Criteria

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