Pelvic Inflammatory DiseasePhase 4NCT03391440
A Trial to Assess the Efficacy and Safety of Morinidazole in Women With Pelvic Inflammatory Disease
A Phase 4 study testing morinidazole in people with Pelvic Inflammatory Disease, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- morinidazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Shixuan Wang contact
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Shixuan Wang, 027-83663078
About this study
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
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
Read the 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.
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- morinidazole
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morinidazoleDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: morinidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure Rate
Clinical cure Rate （according to symptoms and signs） at 7-30 days post-therapy
Measured: 7-30 days
Secondary outcomes (5)
The incidence of AE
The incidence of adverse events
Measured: 14 days
Incidence of ADR
Incidence of adverse reactions
Measured: 14 days
Incidence of serious ADR
Incidence of serious adverse reactions
Measured: 14 days
Bacteriological response（Bacterial elimination rate）
Bacteriological response (on the first day post-therapy, at 7-30 days post-therapy)
Measured: the first day and 7-30 days
PPK parameters
Area under the plasma concentration versus time curve (AUC) of morinidazole
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study startSep 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 469 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391440
- Sponsor's protocol ID
- HS-10090-401
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03391440
- Acronym / sponsor ID
- HS-10090-401
- Conditions
- Pelvic Inflammatory Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 469 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| morinidazole | Experimental | Drug: morinidazolemorinidazole 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- women between 18 and 65 years old
- patients with the diagnosis of PID:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morinidazolemorinidazole 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 |
Primary outcome
Clinical cure Rate
Time frame: 7-30 days
Clinical cure Rate （according to symptoms and signs） at 7-30 days post-therapy
5 secondary outcomes
The incidence of AE
Time frame: 14 days
Incidence of ADR
Time frame: 14 days
Incidence of serious ADR
Time frame: 14 days
Bacteriological response（Bacterial elimination rate）
Time frame: the first day and 7-30 days
PPK parameters
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
Related trials for Pelvic Inflammatory Disease
Not yet recruitingPhase 4
ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery
Ulcerative Colitis (UC), Pouchitis
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Cervical Carcinoma, Endometrial Carcinoma
RecruitingPhase 1/2
Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Endometriosis, Adenomyosis
Not yet recruiting
Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
Cesarean Section, Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shixuan Wang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing morinidazole in people with Pelvic Inflammatory Disease, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shixuan Wang (02783663078), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure Rate (time frame: 7-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.