Clinical trial: A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg (NCT01658020)

Eligibility criteria:
Inclusion Criteria:

          -  Adult male or female same or older than age of 40

          -  Severity of acute exacerbation of Chronic obstructive pulmonary disease(COPD) must
             suit oral administration treatment

          -  Diagnosed as COPD before receiving written informed consent and outcome measure of
             spirometry testing confirmed as [Ratio of Forced Expiratory Volume in 1 second(FEV1)
             to Forced Vital Capacity(FVC)](FEV1/FVC) < 0.7

          -  Subject showing following signs and symptoms:

             (i)Purulent Sputum or Sputum level is increased (ii)Difficulty in breathing is
             increased

          -  Female subjects who might be pregnant must do pregnancy test and results should be
             negative before randomization is done. She must receive written informed consent form
             (NOTE: Subject who has used single hormone contraception for pregnancy control or has
             not been more than 1 year after Tubule ligation and menopause are excluded from the
             study)

          -  Subject who can agree and sign written informed consent form approved by Institutional
             Review Board(IRB) before participating in study and follow study requirements

        Exclusion Criteria:

          -  Subject who administered excess daily dose of antimicrobial/antibiotics in past 72
             hours before receiving written consent

          -  Diagnosed to have pneumonia by taking chest X-ray in past 48 hours before receiving
             written consent

          -  Diagnosed to have infectious diseases or such diseases results in complications before
             receiving written consent (NOTE: Septic shock, Bronchiectasis, Lung abscess,
             Pneumonia, Active tuberculosis, Pulmonary malignancy, Cystic fibrosis, Empyema,
             Asthma)

          -  Have kidney or liver diseases who correspond following criteria:

             (i) Creatinine Clearance(CCr) < 50 mL/min (ii) Blood Urea Nitrogen(BUN) ≥ 30 mg/dl
             (iii) Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 3 x Upper
             Limit Normal(ULN) (iv) Total bilirubin > 2 x ULN (v) Alkaline Phosphatase(ALP) > 2 x
             ULN.

          -  Organic gastrointestinal disorder having abnormal absorption problem condition in past
             6 months before receiving written consent (NOTE: Active Crohn's disease, active
             ulcerative colitis)

          -  Diagnosed to have neutropenia where absolute neutrophil count is < 1,000cells/mm3
             (NOTE: Even though subject neutrophil count is < 1,000cells/mm3, if it is acute
             infection, subject maybe possible to participate)

          -  Chronic Hepatitis B carrier

          -  Have proof that subject is Hepatitis C carrier or have Hepatitis C antibody

          -  Immunodeficiency diseases such as HIV positive, AIDS, Bone marrow transplant or
             leukemia

          -  Have medical history of hypersensitive reaction to antibiotics of fluoroquinolones

          -  Have medical history of seizure or administration of anti-seizure drug in past 1 year
             before receiving written consent (NOTE: Epilepsy, Convulsions, Myasthenia gravis)

          -  Medical history of ventricular arrhythmia

          -  Medical history of QTc prolongation or currently administering drug that delays QTc
             interval (NOTE: QTc prolongation means QTc interval > 450 msec)

          -  Complex infections or diseases that can effect study assessment or need long-term
             antibiotic treatment exceeding 7 days

          -  Subject who has participated in Clinical trials or Bioequivalence test in past 30 days
             before receiving written consent

          -  Clinically significant by observations considered as unsuitable based on medical
             judgement by investigators where current condition can effect quality of safety or
             data
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction