A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP
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|ClinicalTrials.gov Identifier: NCT02205112|
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : November 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Community-acquired Pneumonia||Drug: Nemonoxacin Drug: Levofloxacin||Phase 3|
Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and developed countries. In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor.
This study will evaluate the clinical efficacy, microbiological efficacy and safety of Intravenous nemonoxacin compared with Intravenous levofloxacin in adult patients with community-acquired pneumonia.
Besides, the populationpharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||598 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multi-center, Randomized, Double-Blind, Parallel Comparative, Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin Versus Levofloxain in Treating Adult Patients With CAP|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||May 4, 2017|
|Actual Study Completion Date :||May 15, 2017|
Experimental: Nemonoxacin 500 mg
Nemonoxacin 500mg/250mL, intravenous administration, once daily for 7~14 days
Active Comparator: Levofloxacin 500mg
Levofloxacin: 500mg/100mL, intravenous administration, once daily for 7~14 days
- Per subject clinical cure rate [ Time Frame: end of treatment and 7 to 14 days after the end of treatment ]The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray
- Per subject microbiological cure rate [ Time Frame: end of treatment and 7 to 14 days after the end of treatment ]The microbiological cure rate will be evaluated according to the microbiological identification results of the central laboratory
- Per subject overall cure rate [ Time Frame: end of treatment and 7 to 14 days after the end of treatment ]Evaluate the overall efficacy after a comprehensive consideration of the clinical results and the bacteriological results.
- Safety evaluation [ Time Frame: duration of trial ]Incidence and severity of AE and changes in safety parameters from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205112
|Institute of Antibiotics, Huashan Hospital, Fundan University|
|Shanghai, China, 200040|