Clinical trial NCT03380793: A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis
Official title: An Open-Lable Multicenter Prospective Non-Randomized Trial to Assess the Efficacy and Safety of Morinidazole With Surgery in Patients With Suppurative or Gangrenous Appendicitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Appendicitis
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-12-21
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Acute appendicitis is among the most common cause of acute abdominal pain. In patients with complicated acute appendicitis, postoperative, broad-spectrum antibiotics are always recommended. 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 pelvic inflammatory disease or appendicitis cases had been approved by CFDA in 2014. This phase 4 study is to assess the efficacy, safety, tissue distribution of target organ and Population Pharmacokinetic (PPK) of morinidazole in patients with suppurative or gangrenous appendicitis.

Eligibility criteria: Inclusion Criteria:

* 18 and 65 years old
* A diagnosis of suppurative or gangrenous appendicitis based on:

  1. metastatic right lower abdominal pain
  2. lower abdominal tenderness and/or rebound tenderness
  3. pyrexia (axillary temperature ≥ 37.5 °C), a WBC \> 10\*109/L on routine blood examination
  4. Voluntary signing of written informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical cure Rate
timeFrame: 5-10 days
Secondary outcomes:
measure: Bacteriological response（Bacterial elimination rate）
timeFrame: 5-10 days
measure: Clinical cure Rate on the first day
timeFrame: the first day
measure: Tissue distribution
timeFrame: 5-10 days
measure: PPK parameters
timeFrame: 5-10 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA General Hospital
Study officials:
References: