NCT03551210

Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia

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 Pneumonia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Treatment-naive patients with CAP and patients with treatment failure were screened and if met the eligible criteria were randomized to receive either treatment with investigational product or comparator. Patients started to receive intravenous therapy with Nemonoxacin or Tavanic® and then upon a decision of investigator patients were switched to oral therapy with the same product. Intravenous therapy included two consequence infusions (antibiotic solution and placebo solution) to maintain blinding. Intravenous therapy should have been given for at least 3 days and could have been prolonged by a decision of investigator up to 7 days. Then investigator switched a patient from intravenous to oral therapy on Day 4(8) of the study if the specific criteria of clinical stability were achieved. To maintain blinding during oral antibiotic therapy each Tavanic® tablet was placed into a capsule shell (over-encapsulated), that was identical in appearance to a Nemonoxacin-containing capsules. The average duration of treatment (including intravenous and oral therapy) for each patient was 7(14) days and during this period patients should have stayed at hospital. After completion of the treatment patients could have been discharged from the hospital and returned for examinations within 1-2 days after the last dose (end of treatment visit). Then the patients attended the investigational site within 7-9 days after the last dose (test of cure visit). Then the investigator contacted the patients by phone within 21-23 days after the last dose (long-term follow-up visit).

Conditions

• Pneumonia, Bacterial

Interventions

Type	Name	Description
DRUG	Nemonoxacin	Solution for infusion, 500 mg (250 ml)
DRUG	Nemonoxacin	Capsules, 250 mg
DRUG	Tavanic	Solution for infusion, 500 mg (100 ml)
DRUG	Tavanic	Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg
DRUG	Placebo (250 ml)	0.9% NaCl (250 ml), solution for infusion
DRUG	Placebo (100 ml)	0.9% NaCl (100 ml), solution for infusion

Timeline

• Start date: 2016-05-04
• Primary completion: 2017-12-13
• Completion: 2017-12-26
• First posted: 2018-06-11
• Last updated: 2023-02-16
• Results posted: 2023-02-16

Locations

25 sites across 1 country: Russia