NCT03551210 is a Phase 3 clinical trial of Nemonoxacin in Pneumonia, Bacterial, sponsored by R-Pharm.

Who is sponsoring NCT03551210?

NCT03551210 is sponsored by R-Pharm.

What drugs are being tested in NCT03551210?

Interventions in NCT03551210: Nemonoxacin, Nemonoxacin, Tavanic, Tavanic, Placebo (250 ml), Placebo (100 ml).

What condition does NCT03551210 study?

NCT03551210 studies Pneumonia, Bacterial.

Is NCT03551210 still recruiting?

NCT03551210 is currently completed. Last updated 16 February 2023.

Are results published for NCT03551210?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-02-16 · How we verify

NCT03551210

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 16 February 2023

What this trial tests

Phase 3 trial testing Nemonoxacin in Pneumonia, Bacterial in 342 participants. Completed in 26 December 2017.

Timeline

4 May 2016

Primary endpoint
13 December 2017

26 December 2017

Quick facts

Lead sponsor	R-Pharm
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	342
Start date	4 May 2016
Primary completion	13 December 2017
Estimated completion	26 December 2017
Sites	25 locations across Russia

Drugs / interventions tested

Nemonoxacin (NEMONOXACIN) — full drug profile →
Nemonoxacin (NEMONOXACIN) — full drug profile →
Tavanic — full drug profile →
Tavanic — full drug profile →
Placebo (250 ml) — full drug profile →
Placebo (100 ml) — full drug profile →

Conditions studied

Pneumonia, Bacterial — all drugs for Pneumonia, Bacterial →

Sponsor

R-Pharm — full company profile →

Who can join

Adults 18 to 70, any sex, with Pneumonia, Bacterial. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Clinical Success as Judged by the Investigator Primary · Visit 4 (within 7-9 days after last dose)

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

Group	Value	95% CI
Nemonoxacin	158
Tavanic®	145
Nemonoxacin	6
Tavanic®	8
Nemonoxacin	5
Tavanic®	13

Number of Patients With Clinical Success as Judged by the Investigator Secondary · Visit 2(day 4/8 ot treatment), Visit 3 (within 1-2 days after last dose)

Visit 2

Group	Value	95% CI
Nemonoxacin	164
Tavanic®	154
Nemonoxacin	4
Tavanic®	5
Nemonoxacin	1
Tavanic®	7

Visit 3

Group	Value	95% CI
Nemonoxacin	160
Tavanic®	151
Nemonoxacin	6
Tavanic®	7
Nemonoxacin	3
Tavanic®	8

Number of Patients With Infection Relapse Secondary · Visit 5 (within 21-23 days after last dose)

Group	Value	95% CI
Nemonoxacin	0
Tavanic®	2

Time to Switch Therapy From Intravenous to Oral Therapy Secondary · Up to Visit 2 (day 4/8 ot treatment)

Group	Value	95% CI
Nemonoxacin	4	3 – 5
Tavanic®	4	3 – 5

Number of Patients Required for Other Antibiotic Treatment Secondary · Up to 21-23 days after last dose

Group	Value	95% CI
Nemonoxacin	2
Tavanic®	5

Number of Patients With Microbiological Success Secondary · Visit 2 (day 4/8 ot treatment), 3 (within 1-2 days after last dose), 4 (within 7-9 days after last dose)

Microbiological response is evaluated as microbiological success if culture study demonstrates eradication of pathogen or no material available for culture because of clinical success

Visit 2

Group	Value	95% CI
Nemonoxacin	17
Tavanic®	16

Visit 3

Group	Value	95% CI
Nemonoxacin	19
Tavanic®	16

Visit 4

Group	Value	95% CI
Nemonoxacin	19
Tavanic®	16

Nemnoxacin Concentration Changes Secondary · 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

Cmax - The peak Nemonoxacin concentration at Day 1-2 of treatment C-22.5hours - 22.5-h drug concentration of Nemonoxacin

Cmax

Group	Value	95% CI
Nemonoxacin	8163.84	± 2936.57

C-22.5hours

Group	Value	95% CI
Nemonoxacin	359.63	± 255.88

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

AUC (0-22.5) - Area under the concentration-time curve from 0 to 22.5 hours of Nemonoxacin AUC(0-∞) - Areas under the concentration-time curve from 0 h to infinity of Nemonoxacin

AUC (0-22.5)

Group	Value	95% CI
Nemonoxacin	34372.69	± 12881.56

AUC(0-∞)

Group	Value	95% CI
Nemonoxacin	38560.90	± 15872.29

Сlearance (CL) of Nemonoxacin Secondary · 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

Total systemic clearance of Nemonoxacin

Group	Value	95% CI
Nemonoxacin	247.32	± 86.92

Volume of Distribution at Steady State (Vss) of Nemonoxacin Secondary · 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

Volume of distribution at steady state of Nemonoxacin

Group	Value	95% CI
Nemonoxacin	123.76	± 39.15

Terminal Elimination Half-life (T1/2) of Nemonoxacin Secondary · 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

Terminal elimination half-life of Nemonoxacin

Group	Value	95% CI
Nemonoxacin	7.04	± 1.98

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 23 Days after the last dose of treatment. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nemonoxacin

Serious: 0/171 (0%)

Deaths: 0/171

Tavanic®

Serious: 2/169 (1%)

Deaths: 0/169

Serious adverse events (2 terms)

Reaction	System	Nemonoxacin	Tavanic®
Pneumonia	Infections and infestations	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (32 terms — click to expand)

Reaction	System	Nemonoxacin	Tavanic®
Alanine aminotransferase increased	Investigations	—	—
Platelet count increased	Investigations	—	—
Gamma-glutamyltransferase increased	Investigations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Eosinophilia	Blood and lymphatic system disorders	—	—
Blood creatinine increased	Investigations	—	—
Red blood cell sedimentation rate increased	Investigations	—	—
Injection site pain	General disorders	—	—
Blood glucose increased	Investigations	—	—
Eosinophil count increased	Investigations	—	—
Transaminases increased	Investigations	—	—
Injection site erythema	General disorders	—	—
Injection site reaction	General disorders	—	—
HIV infection	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Blood alkaline phosphatase increased	Investigations	—	—
Blood potassium increased	Investigations	—	—
Blood creatine phosphokinase increased	Investigations	—	—
Electrocardiogram QT prolonged	Investigations	—	—
Injection site hypoaesthesia	General disorders	—	—
Lung infiltration	Respiratory, thoracic and mediastinal disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Pleurisy	Respiratory, thoracic and mediastinal disorders	—	—
Throat irritation	Respiratory, thoracic and mediastinal disorders	—	—
Pneumonia	Infections and infestations	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—
Tachycardia	Cardiac disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Leukocyturia	Renal and urinary disorders	—	—
Hypertension	Vascular disorders	—	—

Most-reported serious reactions: Pneumonia, Respiratory failure.

Data from ClinicalTrials.gov NCT03551210 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacotherapy of Lower Respiratory Tract Infections in Elderly-Focused on Antibiotics.
Liu Y, Zhang Y, Zhao W, Liu X, et al · · 2019 · cited 12× · PMID 31736751 · DOI 10.3389/fphar.2019.01237

Verify or expand the search:

Other trials of Nemonoxacin

Trials testing the same drug.

NCT05133752 — Oral Nemonoxacin in Treating Elderly Patients With CAP · Phase 4 · completed
NCT02604498 — Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function · Phase 1 · completed

Other recruiting trials for Pneumonia, Bacterial

Currently open trials in the same condition.

NCT07428759 — Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years · Phase 1 · recruiting
NCT07105722 — A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years o · Phase 1 · active not recruiting
NCT06238297 — Rapid De-escalation of Anti-MRSA Therapy Guided by S. Aureus Nares Screening in Case of Pneumonia · NA · recruiting
NCT05776004 — Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia · Phase 2 · active not recruiting

Other R-Pharm trials

Trials by the same sponsor.

NCT07386938 — A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetax · Phase 3 · active not recruiting
NCT07435324 — A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck · Phase 3 · active not recruiting
NCT05773170 — Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxys · completed
NCT04684446 — Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19 · Phase 1, PHASE2 · completed
NCT05196477 — Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03551210 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by R-Pharm
Last refreshed: 16 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03551210.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing