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

NCT03551210 | Completed Phase 3 Results

• 1 other identifier: CJ01060044
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 25

Brief 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

Keywords

nemonoxacin; community-acquired pneumonia; quinolones

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Clinical Success as Judged by the Investigator

  Clinical response is evaluated as clinical success if: all signs and symptoms of pneumonia are resolved or improved with no worsening or appearance of new signs and symptoms of pneumonia; there is no requirement for additional antibiotic therapy; chest roentgenograms (CT scans) are cured or improved

  Visit 4 (within 7-9 days after last dose)

Secondary Outcomes (5)

• Number of Patients With Clinical Success as Judged by the Investigator

  Visit 2(day 4/8 ot treatment), Visit 3 (within 1-2 days after last dose)

• Number of Patients With Infection Relapse

  Visit 5 (within 21-23 days after last dose)

• Time to Switch Therapy From Intravenous to Oral Therapy

  Up to Visit 2 (day 4/8 ot treatment)

• Number of Patients Required for Other Antibiotic Treatment

  Up to 21-23 days after last dose

• Number of Patients With Microbiological Success

  Visit 2 (day 4/8 ot treatment), 3 (within 1-2 days after last dose), 4 (within 7-9 days after last dose)

Other Outcomes (5)

• Nemnoxacin Concentration Changes

  Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

• Area Under the Concentration-time Curve (AUC) of Nemonoxacin

  Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

• Сlearance (CL) of Nemonoxacin

  Day 1 pre-dose and 0, 0.5, 2.5, 4, 6, 12, 16 and 22.5 (= Day 2 pre-dose) hrs after the end of first infusion on Day 1 of treatment

Study Arms (2)

Nemonoxacin

EXPERIMENTAL

Nemonoxacin solution for infusion, 500 mg (250 ml), daily, as single intravenous infusion over 90-110 minutes followed by infusion of Placebo (100 ml), solution for infusion, over a minimum duration of 60 minutes. Then will be switched to oral therapy with Nemonoxacin capsules, 500 mg once daily (two 250 mg capsules).

Drug: Nemonoxacin; Drug: Placebo (100 ml)

Tavanic®

ACTIVE COMPARATOR

Tavanic® solution for infusion, 500 mg (100 ml), daily, as single intravenous infusion over a minimum duration of 60 minutes with previous infusion of Placebo (250 ml), solution for infusion, over 90-110 minutes. Then will be switched to oral therapy with Tavanic®, over-encapsulated film coated tablets, 500 mg once daily (two capsules each containing 250 mg film coated tablet).

Drug: Tavanic; Drug: Placebo (250 ml)

Interventions

Nemonoxacin DRUG

Solution for infusion, 500 mg (250 ml)

Nemonoxacin

Tavanic DRUG

Solution for infusion, 500 mg (100 ml)

Also known as: Levofloxacin

Tavanic®

Placebo (250 ml) DRUG

0.9% NaCl (250 ml), solution for infusion

Tavanic®

Placebo (100 ml) DRUG

0.9% NaCl (100 ml), solution for infusion

Nemonoxacin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• cough;
• purulent sputum production;
• tachypnea (respiratory rate \> 24 breathes/minute);
• chills;
• fever (rectal / tympanic temperature ≥ 38.5°C or axillary / oral / skin temperature ≥ 38.5°C);
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• R-Pharm: lead
• OCT Clinical Trials: collaborator

Study Sites (25)

Regional budget healthcare institution "Ivanovo regional clinical hospital"

Ivanovo, Russia

Location

City clinical hospital #1 n.a. N.I. Pirogov of Moscow Healthcare Department

Moscow, Russia

Location

City Clinical hospital n.a. V. V. Vinogradov

Moscow, Russia

Location

FSOE Main Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defence of the Russian Federation

Moscow, Russia

Location

SBHI Moscow City clinical hospital # 15 n.a. O.M. Filatov of Moscow Healthcare Department

Moscow, Russia

Location

City Clinical Hospital #25

Novosibirsk, Russia

Location

City clinical hospital #2

Novosibirsk, Russia

Location

SBHI of Novosibirsk region City Clinical Hospital of Emergency Medical Care №2

Novosibirsk, Russia

Location

Republic Hospital named after V.A. Baranov

Petrozavodsk, Russia

Location

Pskov regional clinical hospital

Pskov, Russia

Location

Baltic Medicine LLC

Saint Petersburg, Russia

Location

City Hospital #15

Saint Petersburg, Russia

Location

City Hospital #26

Saint Petersburg, Russia

Location

City hospital #38 n.a. N.A. Semashko

Saint Petersburg, Russia

Location

Mariinsky City Hospital

Saint Petersburg, Russia

Location

Multidisciplinary City Hospital # 2

Saint Petersburg, Russia

Location

Scientific Research Institute of Influenza of the Ministry of Healthcare of Russian Federation

Saint Petersburg, Russia

Location

Regional clinical hospital

Saratov, Russia

Location

Clinical hospital of emergency medical care

Smolensk, Russia

Location

Scientific Research Institute of Antimicrobial Therapy of Smolensk State Medical University

Smolensk, Russia

Location

Siberian State Medical University of the Ministry of Healthcare of Russian Federation

Tomsk, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Russia

Location

Voronezh Regional Clinical Hospital #1

Voronezh, Russia

Location

Central city hospital #7

Yekaterinburg, Russia

Location

City clinical hospital #40

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Pneumonia, Bacterial; Community-Acquired Pneumonia

Interventions

nemonoxacin; Ofloxacin; Levofloxacin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Aleksandr Chernavin, Regional Medical Director
• Organization: R-Pharm

chernavin@rpharm.ru

0074959567937

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All eligible patients will be randomized to receive either treatment with Nemonoxacin or Tavanic® in a ratio of 1:1.

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 11, 2018
• Study Start: May 4, 2016
• Primary Completion: December 13, 2017
• Study Completion: December 26, 2017
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2023-01

Locations

RU (25)