Clinical trial NCT03675841: Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
Official title: A Phase I，Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Suppurative Otitis Media
Keywords: Pazufloxacin Mesilate ear drops
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.

Detailed description: The test group was completed in sequence from low to high concentrations, and safety tolerance was assessed after administration in one concentration group to determine whether to conduct follow-up group studies and, if necessary, adjust sampling time points according to pre-experimental results.

Eligibility criteria: Inclusion Criteria:

1. Age is 18-65 years old. Men and women are not restricted.
2. Clinical diagnosis of simple chronic suppurative otitis media with ear effusion secretion, tympanic membrane perforation about 2 mm, the need for local use of antibiotics in patients.
3. Voluntarily sign written informed consent.
4. Non-breast-feeding women volunteered to take appropriate contraceptive measures (including abstinence, intrauterine devices, diaphragms and spermicides) during the study period (screening period to one week after administration). Men are willing to use approved contraceptive methods (including the use of condoms and spermicides or the use of oral, implantable or injectable contraceptives by their partners, intrauterine devices, diaphragms and spermicides) or sexual partner infertility.

Exclusion Criteria:

1. Quinolone antibiotics allergy and severe allergic constitution.
2. During the study, ear fluid could not be collected.
3. Patients with severe need for systemic use of antibiotics.
4. Infections caused by pathogens such as fungi and viruses (bullous tympanitis).
5. Patients with cholesteatoma.
6. Complicated with symptoms of extraaural infection (such as periaural cellulitis, mumps) or intracranial and extracranial complications (such as meningitis, brain abscess, thrombophlebitis of sigmoid sinus, subperiosteal abscess of the ear, Bezold's abscess of the neck).
7. Suffer from severe brain, heart, lung, liver, kidney and blood diseases.
8. People suffering from severe diseases that affect their survival, such as malignant tumors or AIDS, etc.
9. Abnormal liver and kidney function (ALT, Angiotensin sensitivity test(AST) ≥ 1.5 times the upper limit of normal value), creatinine clearance rate \< 60ml/min).
10. Use any local or systemic antibiotics in the first 3 days of the admission.
11. Use any quinolones within the first 7 days of admission.
12. There were smokers who smoked more than 5 cigarettes a day within one year.
13. There was a history of alcoholism and drug abuse within one year.
14. Diagnosis of diabetes or poor blood glucose control.
15. Those who are unable to cooperate or unwilling to cooperate with neuropsychiatric disorders.
16. Pregnant or lactating women, those who do not use contraceptive measures as required, or those who are unwilling to take contraceptive measures.
17. Patients who took part in other clinical trials in the first 3 months.
18. Blood donation within three months before admission, or intended during or three months after the end of the trial or blood components.
19. Researchers believe that patients who are not fit to participate in this clinical trial.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Within two days after administration
Secondary outcomes:
measure: Cmax
timeFrame: Within two days after administration
measure: Tmax
timeFrame: Within two days after administration
measure: Area under concentration time curve
timeFrame: Within two days after administration
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province People's Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu Province People's Hospital
name: lei chen, PHD
role: STUDY_DIRECTOR
References: