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

NCT03551210 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2023-02-16

Study results available
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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).

Conditions

  • Pneumonia, Bacterial

Interventions

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

Sponsors & Collaborators

  • OCT Clinical Trials

    collaborator OTHER

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-04
Primary Completion
2017-12-13
Completion
2017-12-26

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03551210 on ClinicalTrials.gov