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

NCT ID: NCT03551210

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-04
• Study Completion Date: 2017-12-26

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nemonoxacin

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).

Group Type: EXPERIMENTAL

Nemonoxacin

Intervention Type: DRUG

Solution for infusion, 500 mg (250 ml)

Nemonoxacin

Intervention Type: DRUG

Capsules, 250 mg

Placebo (100 ml)

Intervention Type: DRUG

0.9% NaCl (100 ml), solution for infusion

Tavanic®

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).

Group Type: ACTIVE_COMPARATOR

Tavanic

Intervention Type: DRUG

Solution for infusion, 500 mg (100 ml)

Tavanic

Intervention Type: DRUG

Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg

Placebo (250 ml)

Intervention Type: DRUG

0.9% NaCl (250 ml), solution for infusion

Interventions

Nemonoxacin

Solution for infusion, 500 mg (250 ml)

Intervention Type: DRUG

Nemonoxacin

Capsules, 250 mg

Intervention Type: DRUG

Tavanic

Solution for infusion, 500 mg (100 ml)

Intervention Type: DRUG

Tavanic

Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg

Intervention Type: DRUG

Placebo (250 ml)

0.9% NaCl (250 ml), solution for infusion

Intervention Type: DRUG

Placebo (100 ml)

0.9% NaCl (100 ml), solution for infusion

Intervention Type: DRUG

Other Intervention Names

Levofloxacin; Levofloxacin

Eligibility 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 / skin 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.
• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OCT Clinical Trials

OTHER

Sponsor Role: collaborator

R-Pharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikhail Samsonov

Role: STUDY_DIRECTOR

R-Pharm

Locations

Regional budget healthcare institution "Ivanovo regional clinical hospital"

Ivanovo, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

City Clinical Hospital #25

Novosibirsk, , Russia

City clinical hospital #2

Novosibirsk, , Russia

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

Novosibirsk, , Russia

Republic Hospital named after V.A. Baranov

Petrozavodsk, , Russia

Pskov regional clinical hospital

Pskov, , Russia

Baltic Medicine LLC

Saint Petersburg, , Russia

City Hospital #15

Saint Petersburg, , Russia

City Hospital #26

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Mariinsky City Hospital

Saint Petersburg, , Russia

Multidisciplinary City Hospital # 2

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Regional clinical hospital

Saratov, , Russia

Clinical hospital of emergency medical care

Smolensk, , Russia

Scientific Research Institute of Antimicrobial Therapy of Smolensk State Medical University

Smolensk, , Russia

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

Tomsk, , Russia

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, , Russia

Voronezh Regional Clinical Hospital #1

Voronezh, , Russia

Central city hospital #7

Yekaterinburg, , Russia

City clinical hospital #40

Yekaterinburg, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CJ01060044

Identifier Type: -

Identifier Source: org_study_id