An International, Multicenter, Randomized, Double-blind, Double-dummy, Two-way, Parallel Group, Controlled Study to Compare the Efficacy and Safety of Intravenous and Oral Nemonoxacin Versus Tavanic® in Adult Patients With Community-acquired Pneumo

• Status: Completed
• Trial end date: 2017-12-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R-Pharm
• Collaborator: OCT Clinical Trials
• Treatments: Levofloxacin; Ofloxacin; Pharmaceutical Solutions

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 / cutaneous 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.

• 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.