A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis

NCT03380793 | Unknown Phase 4

• 1 other identifier: HS-10090-402
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole and sodium chloride injection with surgery in patients with suppurative or gangrenous appendicitis

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• Clinical cure Rate

  Clinical cure Rate （according to symptoms and signs） at 5-10 days post-therapy

  5-10 days

Secondary Outcomes (4)

• Bacteriological response（Bacterial elimination rate）

  5-10 days

• Clinical cure Rate on the first day

  the first day

• Tissue distribution

  5-10 days

• PPK parameters

  5-10 days

Study Arms (1)

morinidazole

EXPERIMENTAL

morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.

Drug: morinidazole

Interventions

morinidazole DRUG

morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.

morinidazole

Eligibility Criteria

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

You may qualify if:

• and 65 years old
• A diagnosis of suppurative or gangrenous appendicitis based on:
• metastatic right lower abdominal pain
• lower abdominal tenderness and/or rebound tenderness
• pyrexia (axillary temperature ≥ 37.5 °C), a WBC \> 10\*109/L on routine blood examination
• Voluntary signing of written informed consent

You may not qualify if:

• patients with an allergy to nitroimidazole
• patients with a history of antibiotic therapy within the last 48 hours
• patients with any condition likely to require broad spectrum antibiotics
• patients who can not evaluate the efficacy or difficult to complete the desired course of treatment
• ALT and / or AST ≥ 1.5 times the ULN, and / or serum creatinine ≥ the ULN
• patients with severe systemic diseases likely to affect therapy (e.g., cardiovascular abnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy)
• patients with other diseases or use other drugs which may interfere with the efficacy or safety of the drug
• patients who participated other clinical trials within 6 months before the start of the trial
• Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

PLA General Hospital

Beijing, 100853, China

RECRUITING

MeSH Terms

Conditions

Appendicitis

Interventions

morinidazole

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Central Study Contacts

Yun Tang

CONTACT

13701393663

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: December 21, 2017
• Study Start: September 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 21, 2017

Record last verified: 2017-11

Locations

CN (1)