A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control

Study Overview
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Brief Summary
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prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated lower urinary tract infection in chinese

Official Title
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A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control

Conditions
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Acute Lower Urinary Tract Infection

Intervention / Treatment
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* Drug: prulifloxacin
* Drug: Levofloxacin
* Drug: Prulifloxacin Placebo
* Drug: Levofloxacin Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18   65 years old; Presence at least two of the following clinical signs and symptoms of acute uncomplicated lower urinary tract infection: dysuria, frequency, urgency and suprapubic pain) with onset of symptoms ≤ 72 hours prior to study entry; With pyuria: WBC > 10/mm3 in unspun urine examined in a counting chamber or WBC > 5/hp [or the Upper laboratory Norm (UNL)] in the resuspended sediment of a centrifuged aliquot of urine (or the UNL); Patient is willing to participate in the study and gives the signature of informed consent form; Exclusion Criteria: Presence of clinical signs and symptoms suggestive of pyelonephritis or complicated urinary tract infection (e.g., fever > 37.5°C, chills, flank pain), or with factors associated with complicated urinary tract infections such as presence of an indwelling catheter or urologic abnormalities; Women who are pregnant, nursing or plan to become pregnant in the near future (i.e., in three months). Women of childbearing potential (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential) must have a negative serum pregnancy test at screening and must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable methods of contraception include tubal ligation, oral contraceptive, barrier methods (intra-uterine device, diaphragm, female condom, male condom); Three or more episodes of acute uncomplicated UTI in the past 12 months; Patients with overactive bladder; Patients are hypersensitive to quinolones or with allergic constitution; Administration of xanthines, fenbufen, antibiotics or antibacterials within the two previous weeks; Patients with severe condition which need combination with other antibacterial agents or corticosteroids during the study; Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, Inflammatory bowel disease, lactose intolerance, or malabsorption syndrome) Patients with severe liver or kidney disease, defined as serum ALT and AST ≥ 2.5 x ULN and creatinine ≥ 1.5 x ULN; Patients with severe heart disease or Q-T prolongation indicated by 12-lead ECG, or arrhythmia or acute myocardial ischemia; WBC < 3.6 × 109/L or neutrophil < 1.8 × 109/L, and/or platelets < 90 × 109/L at screening; Patients with central nervous system disease or convulsion history, and/or with mental status unable to coordinate; Patients with malignant tumor or other severe background disease; Patients with severe immunodeficiency; Patients with a history of tendinopathy or who are currently having the disease, including tendinitis and tendon rupture; Patients treated with experimental drugs in the previous 4 weeks or currently; Considered inappropriate for the study by investigators, including patients who are unable or unwilling to show compliance with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prulifloxacin<br>Prulifloxacin film-coated tablet : 600 mg/tablet, oral administration of a single tablet. Placebo of levofloxacin hydrochloride tablet without active components. | Drug: prulifloxacin<br> <br> Drug: Levofloxacin Placebo<br>* Placebo of levofloxacin hydrochloride tablet without active components.<br>|
| Active Comparator: Levofloxacin<br>Levofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days. Placebo of prulifloxacin film-coated tablet, without active components. | Drug: Levofloxacin<br>* Levofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days.<br>Drug: Prulifloxacin Placebo<br>* Placebo of prulifloxacin film-coated tablet without active components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of prulifloxacin film-coated tablet was meaured by the number of patient have been cured | 600mg single dose prolifloxacin is not inferior to Levoflxacin on low urine infection in Chinese | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of prulifloxacin film-coated tablet was measured by the number fo AE and SAE | The susceptibility of infecting strains to prulifloxacin; The rate of return to normal of WBC (white blood cell) in urine in treatment and control group The safety and tolerability of prulifloxacin in adult patients with acute lower urinary tract infection | 3 days and 28 days |