Pneumonia, BacterialPhase 3NCT03551210
Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia
A Phase 3 study testing Nemonoxacin and Tavanic in people with Pneumonia, Bacterial, run by R-Pharm at 25 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pneumonia, Bacterial
- What is being tested?
- Nemonoxacin and Tavanic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 25 sitesRussia
- Study dates
- 4 May 2016to 26 Dec 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 12Show fewer
- 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).
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Russia25 sites
Regional budget healthcare institution "Ivanovo regional clinical hospital"
Ivanovo
City clinical hospital #1 n.a. N.I. Pirogov of Moscow Healthcare Department
Moscow
City Clinical hospital n.a. V. V. Vinogradov
Moscow
FSOE Main Military Clinical Hospital n.a. academician N.N. Burdenko of the Ministry of Defence of the Russian Federation
Moscow
SBHI Moscow City clinical hospital # 15 n.a. O.M. Filatov of Moscow Healthcare Department
Moscow
City Clinical Hospital #25
Novosibirsk
City clinical hospital #2
Novosibirsk
SBHI of Novosibirsk region City Clinical Hospital of Emergency Medical Care №2
Novosibirsk
Republic Hospital named after V.A. Baranov
Petrozavodsk
Pskov regional clinical hospital
Pskov
Baltic Medicine LLC
Saint Petersburg
City Hospital #15
Saint Petersburg
City Hospital #26
Saint Petersburg
City hospital #38 n.a. N.A. Semashko
Saint Petersburg
Mariinsky City Hospital
Saint Petersburg
Multidisciplinary City Hospital # 2
Saint Petersburg
Scientific Research Institute of Influenza of the Ministry of Healthcare of Russian Federation
Saint Petersburg
Regional clinical hospital
Saratov
Clinical hospital of emergency medical care
Smolensk
Scientific Research Institute of Antimicrobial Therapy of Smolensk State Medical University
Smolensk
Siberian State Medical University of the Ministry of Healthcare of Russian Federation
Tomsk
Ulyanovsk Regional Clinical Hospital
Ulyanovsk
Voronezh Regional Clinical Hospital #1
Voronezh
Central city hospital #7
Yekaterinburg
City clinical hospital #40
Yekaterinburg
About this study
Official title: 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
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).
Read the 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
- Being tested
- Nemonoxacin, Tavanic, Placebo (250 ml), Placebo (100 ml)
- Keywords
- nemonoxacin, community-acquired pneumonia, quinolones
- Medical subject headings
- Pneumonia, Bacterial, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemonoxacinDrug
Solution for infusion, 500 mg (250 ml)
NemonoxacinDrug
Capsules, 250 mg
TavanicDrug
Also called Levofloxacin
Solution for infusion, 500 mg (100 ml)
TavanicDrug
Also called Levofloxacin
Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg
Placebo (250 ml)Drug
0.9% NaCl (250 ml), solution for infusion
Placebo (100 ml)Drug
0.9% NaCl (100 ml), solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Tavanic; Drug: Placebo (250 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visit 4 (within 7-9 days after last dose)
Secondary outcomes (5)
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
Measured: Visit 2(day 4/8 ot treatment), Visit 3 (within 1-2 days after last dose)
Number of Patients With Infection Relapse
Measured: Visit 5 (within 21-23 days after last dose)
Time to Switch Therapy From Intravenous to Oral Therapy
Measured: Up to Visit 2 (day 4/8 ot treatment)
Number of Patients Required for Other Antibiotic Treatment
Measured: Up to 21-23 days after last dose
Number of Patients With Microbiological Success
Microbiological response is evaluated as microbiological success if culture study demonstrates eradication of pathogen or no material available for culture because of clinical success
Measured: Visit 2 (day 4/8 ot treatment), 3 (within 1-2 days after last dose), 4 (within 7-9 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start4 May 2016
- Primary completion13 Dec 2017
- Study completion26 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All eligible patients will be randomized to receive either treatment with Nemonoxacin or Tavanic® in a ratio of 1:1.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OCT Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551210
- Sponsor's protocol ID
- CJ01060044
- Status last verified
- Jan 2023
- First submitted
- 28 May 2018
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03551210
- Acronym / sponsor ID
- CJ01060044
- Conditions
- Pneumonia, Bacterial
- Keywords
- nemonoxacin, community-acquired pneumonia, quinolones
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- OCT Clinical Trials
- Study start
- 4 May 2016 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 26 Dec 2017 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All eligible patients will be randomized to receive either treatment with Nemonoxacin or Tavanic® in a ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Nemonoxacin | Experimental | Drug: Nemonoxacin, Drug: Placebo (100 ml)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). |
| Tavanic® | Active comparator | Drug: Tavanic, Drug: Placebo (250 ml)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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NemonoxacinSolution for infusion, 500 mg (250 ml) | Drug | Nemonoxacin |
| NemonoxacinCapsules, 250 mg | Drug | Nemonoxacin |
| TavanicAlso: LevofloxacinSolution for infusion, 500 mg (100 ml) | Drug | Tavanic® |
| TavanicAlso: LevofloxacinFilm coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg | Drug | Tavanic® |
| Placebo (250 ml)0.9% NaCl (250 ml), solution for infusion | Drug | Tavanic® |
| Placebo (100 ml)0.9% NaCl (100 ml), solution for infusion | Drug | Nemonoxacin |
Primary outcome
Number of Patients With Clinical Success as Judged by the Investigator
Time frame: 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
5 secondary outcomes
Number of Patients With Clinical Success as Judged by the Investigator
Time frame: Visit 2(day 4/8 ot treatment), Visit 3 (within 1-2 days after last dose)
Number of Patients With Infection Relapse
Time frame: Visit 5 (within 21-23 days after last dose)
Time to Switch Therapy From Intravenous to Oral Therapy
Time frame: Up to Visit 2 (day 4/8 ot treatment)
Number of Patients Required for Other Antibiotic Treatment
Time frame: Up to 21-23 days after last dose
Number of Patients With Microbiological Success
Time frame: Visit 2 (day 4/8 ot treatment), 3 (within 1-2 days after last dose), 4 (within 7-9 days after last dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pneumonia, Bacterial
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Samsonov study director
R-Pharm
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nemonoxacin and Tavanic in people with Pneumonia, Bacterial, run by R-Pharm at 25 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Clinical Success as Judged by the Investigator (time frame: Visit 4 (within 7-9 days after last dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.