Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia
Condition: Pneumonia, Bacterial
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Nemonoxacin; Nemonoxacin; Tavanic; Tavanic; Placebo (250 ml); Placebo (100 ml)
Intervention description: Solution for infusion, 500 mg (250 ml); Capsules, 250 mg; Solution for infusion, 500 mg (100 ml); Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg; 0.9% NaCl (250 ml), solution for infusion; 0.9% NaCl (100 ml), solution for infusion
Intervention MeSH terms: Levofloxacin; Ofloxacin; Nemonoxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All eligible patients will be randomized to receive either treatment with Nemonoxacin or Tavanic® in a ratio of 1:1.
Masking: Double (Participant, Investigator)
Enrollment: 342.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: nemonoxacin; community-acquired pneumonia; quinolones

Summary:

      The primary objective of this study was to evaluate the clinical efficacy of treatment with
      Nemonoxacin compared with Tavanic® in patients with community-acquired pneumonia (CAP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained from the patient.

          -  Patients with moderate to severe community-acquired pneumonia who need inpatient
             treatment but do not need intensive care unit treatment.

          -  The presence of at least 3 of the following symptoms / signs:

               1. cough;

               2. purulent sputum production;

               3. tachypnea (respiratory rate > 24 breathes/minute);

               4. chills;

               5. fever (rectal / tympanic temperature ≥ 38.5°C or axillary / oral / skin
                  temperature ≥ 38.5°C);

               6. white blood cells (WBC) count of ≥ 10.0 x 10^9/L or ≥ 15% immature neutrophils
                  (bands; regardless of peripheral WBC count).

          -  Radiological evidence of (a) new infiltrate(s) consistent with bacterial pneumonia at
             baseline.

          -  Treatment-naive patients or patients who have received single dose of a short-acting
             antibacterial drug within 24 hours of enrollment or patients with treatment failure
             who have received antibiotics (with the exception of quinolones or fluoroquinolones)
             for less than 72 hours.

          -  Consent to use contraception during participation in the study (for women of
             childbearing potential and men).

        Exclusion Criteria:

          -  Known hypersensitivity to quinolones, fluoroquinolones or any of the excipients.

          -  Female patients who are pregnant or nursing.

          -  History of tendon disease / disorder related to quinolone treatment.

          -  Known congenital or documented-acquired QT / QTc(F) prolongation on ECG (QTc(F)
             interval more than 450 ms); concomitant use of drugs, reported to increase the QT
             interval; uncorrected hypokalaemia and uncorrected hypomagnesemia; clinically relevant
             bradycardia; clinically relevant heart failure with reduced left-ventricular ejection
             fraction; previous history of symptomatic arrhythmias.

          -  History of bronchiectasis, cystic fibrosis, bronchial obstructions excluding chronic
             obstructive pulmonary disease.

          -  History of epilepsy and/or history of psychotic disorder.

          -  Patients with history of myasthenia gravis.

          -  Patients with diabetes mellitus.

          -  Known glucose-6-phosphate dehydrogenase deficiency.

          -  Active hepatitis or decompensated cirrhosis.

          -  Alanine transaminase or aspartate transaminase increase > 3 fold upper limit of normal
             (ULN).

          -  Patients with creatinine ≥ 1.1 fold ULN.

          -  Patients requiring concomitant systemic or inhaled antibiotics (e.g., tobramycin).

          -  Known or suspected active tuberculosis or endemic fungal infection.

          -  Concomitant immunosuppressive therapy including a long-term (more than 2 weeks)
             treatment with oral or intravenous glucocorticoids at doses of 20 mg and higher of
             prednisone daily or an equivalent dose of other glucocorticoids.

          -  Patients known to have HIV-positive status or AIDS or known to have other disease that
             seriously affects the immune system such as active haematological or solid organ
             malignancy, or splenectomy.

          -  History of drug or alcohol abuse.

          -  Patients have received quinolones or fluoroquinolones within 14 days before
             enrollment.

          -  Previous enrolment in this study or participation in another study within the previous
             4 weeks.

          -  Patients with any severe medical condition as determined by medical history that, in
             the opinion of the investigator, does not allow the patient to carry out all planned
             procedure of the protocol.