Community-acquired PneumoniaPhase 3NCT06263881
Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia
A Phase 3 study testing Raphamin in people with Community-acquired Pneumonia and Pneumonia, run by Materia Medica Holding at 38 sites in Russia.
Trial summary
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Community-acquired Pneumonia, Pneumonia
- What is being tested?
- Raphamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 38 sitesRussia
- Study dates
- 1 Dec 2023to 19 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18-65 years.
- The diagnosis of community-acquired pneumonia presupposes that the patient has focal infiltration of the lung tissue, confirmed by imaging (X-ray/CT), and the presence of at least two clinical symptoms:
- а) acute fever at the onset of the disease (axillary temperature ≥ 38.0°C); b) wet cough; c) physical signs (crepitus/wheezing, bronchial breathing sounds, local dullness to percussion); d) leukocytosis >10×10^9/L and/or shift of band neutrophils (>10%).
- SpO2 ≥95% according to pulse oximetry.
- Overall CRB-65 score "0" points.
- Patients willing to use reliable methods of contraception during the study (men and women of reproductive potential).
- Patients who have signed the patient information sheet and informed consent.
Who cannot join
- Any indications for patient hospitalization.
- Suspected infiltrative pulmonary tuberculosis.
- Medical history of/suspected malignant neoplasm of any location, including primary lung cancer and metastases to the lung parenchyma.
- Suspected pulmonary embolism and pulmonary infarction.
- Medical history of chronic obstructive pulmonary disease, bronchial asthma, chronic respiratory failure.
- Medical history of immune system diseases: systemic vasculitis, lupus pneumonitis, allergic bronchopulmonary aspergillosis, obliterating bronchiolitis, idiopathic pulmonary fibrosis, eosinophilic pneumonia, bronchocentric granulomatosis.
Show all 23Show fewer
- Chronic heart failure III or IV FC (according to the New York Heart Association classification, 1964).
- Suspicion of drug-induced (toxic) pneumopathy, aspiration of foreign body, sarcoidosis, pulmonary alveolar proteinosis, lipoid pneumonia, rounded atelectasis.
- Exacerbated or decompensated chronic diseases, including diabetes mellitus, affecting a patient's ability to participate in the clinical trial.
- Prior diagnosis of immunodeficiency of any etiology.
- Patients having unstable angina pectoris or myocardial infarction in the previous 6 months.
- Prior history of chronic kidney disease (categories С3-5 А3).
- Prior history of hepatic failure (Child-Pugh class C).
- Any surgery within the previous 3 months.
- Patients who received any medicine specified in the section "Prohibited concomitant treatment" within 3 months preceding the inclusion in this study or who require the use of medicines that are prohibited within this trial.
- Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.
- Hypersensitivity to any of the components of medications used in the treatment.
- Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
- Patients who, from the investigator's point of view, will not comply with study monitoring requirements or with study drug administration requirements.
- Prior history of a psychiatric disorder, alcoholism or drug abuse, which in the opinion of the investigator may compromise compliance with the study protocol.
- Participation in other clinical studies within 3 month prior to enrollment in the study.
- Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parents, children, or siblings, regardless of whether they are natural or adopted.
- Patients who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract employees, persons designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Russia38 sites
Aramil city hospital
Aramil, 624002
Northern Medical Clinical Center named after N.A. Semashko Federal Medical and Biological Agency
Arkhangelsk, 163000
Gatchina Clinical Interdistrict Hospital
Gatchina, 188300
Ivanovo Clinical Hospital named after Kuvayevs
Ivanovo, 153025
City Clinical Hospital # 9 of the Ministry of Health of the Udmurt Republic
Izhevsk, 426063
Central City Clinical Hospital
Kaliningrad, 236005
Kazan State Medical University/Department of Infectious Diseases
Kazan', 420012
Kazan State Medical University
Kazan', 420012
Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology
Krasnodar, 350063
Central Research Institute of Epidemiology
Moscow, 111123
First Moscow State Medical University named after I.M. Sechenov
Moscow, 119991
Moscow Regional Research Clinical Institute named after. M.F. Vladimirsky
Moscow, 129110
Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
Nizhny Novgorod, 603093
LLC "Persona group of companies"
Nizhny Novgorod, 603155
Clinical Hospital # 4
Penza, 440067
LLC "Professor's clinic"
Perm, 614070
Nikolaevskaya hospital
Petergof, 198510
LLC "4D Ultrasound Clinic"
Pyatigorsk, 357502
Rostov Central District Hospital
Rostov-on-Don, 152155
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, 191036
LLC "Energy of Health"
Saint Petersburg, 194156
LLC "Medical center "Reavita Med SPb"
Saint Petersburg, 194354
LLC "Medical Clinic"
Saint Petersburg, 194356
City Polyclinic # 112
Saint Petersburg, 195427
LLC "Zvezdnaya Clinic"
Saint Petersburg, 196158
City Pokrovskaya Hospital
Saint Petersburg, 199106
City Polyclinic # 4
Saint Petersburg, 199178
LLC "Meili"
Saint Petersburg, 199406
Medical University "Reaviz"
Samara, 443001
Samara State Medical University/Department of General and Clinical Microbiology, Immunology and Allergology
Samara, 443099
Smolensk State Medical University
Smolensk, 214019
LLC "Scientific Medical Center of General Therapy and Pharmacology"
Stavropol, 355000
Bashkir State Medical University/Department of Internal Medicine
Ufa, 450008
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432017
Regional Clinic Hospital
Vladimir, 600023
Voronezh Regional Clinical Hospital # 1
Voronezh, 394066
Clinical Hospital # 2
Yaroslavl, 150030
LLC "Medical Center for Diagnostics and Prevention Plus"
Yaroslavl, 150040
About this study
Official title: Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.
Read the detailed description
Design: a multicenter, double-blind, placebo-controlled, randomized in parallel-group trial.
The study enrolls male and female outpatients aged 18 to 65 years with typical symptoms of community-acquired pneumonia (CAP): axillary body temperature ≥38.00C, acute cough, shortness of breath (dyspnea), chest pain when breathing, fatigue, night sweats. Symptoms are associated with previous upper respiratory tract infection or acute bronchitis. The investigator assesses a prognosis and determines where the patient will receive treatment using the CRB-65 score which includes estimation of Confusion, Respiratory rate, Blood pressure, and Age (≥ 65 years) (min "0", max "4" points; only estimation "0" points is indication for outpatient treatment).
At the first visit (day 1), after signing the patient information sheet and informed consent form for participation in a clinical trial, the investigator collects complaints and medical history, conducts a physical examination and assessment of vital signs, and measures capillary blood oxygen saturation (SpO2), records comorbidities and concomitant therapies, collects blood samples for laboratory tests, and orders a dual-view chest X-ray or chest CT scan. If X-ray/CT shows no changes in the lungs or changes that are not typical for pneumonia, the patient is not included in the clinical trial. The investigator determines a therapeutic approach in compliance with the current standards.
At the first visit (day 1), patients are randomized to one of two treatment groups: patients in Group 1 receive Amoxicillin + Clavulanic acid (Amoxiclav) and Rafamine for 7 days; patients in Group 2 take Amoxiclav and Placebo for 7 days. All patients are provided with the drug Amoxiclav. In addition, all patients are provided with the antipyretic drug Paracetamol and a classic mercury-free thermometer to measure axillary temperature.
A second visit (3/4 days) is carried out 48-72 hours after the start of treatment to assess the effectiveness and safety of the initial course of antibiotic therapy. The investigator collects complaints, performs physical examination, and evaluates the vital signs and SpO2 level. If there is no response to initial antibiotic therapy, the decision about the therapeutic approach is made by the investigator. If hospitalization occurs, the patient ends participation in the study because he or she has reached the study endpoint.
If antibiotic therapy is effective, it is continued for 7 days. After 7 days of treatment, a third visit is carried out (day 8), at which the researcher collects the patient's complaints, conducts a physical examination and assessment of vital signs, measures SpO2 and prescribes a clinical blood test. If the patient meets the criteria for sufficiency of antibiotic therapy, the investigator stops prescribing the antibiotic.
If a positive response to the first course of antibiotic therapy is achieved, the patient continues to participate in the study. The patient is observed for 7 days. On day 15±1, the fourth visit is carried out, during which the researcher collects the patient's complaints, conducts a physical examination and assesses vital signs, measures SpO2 and prescribes a follow-up X-ray/CT scan. The patient returns the study drug and the investigator performs a compliance calculation. In total, patients are observed for 15 days.
The study uses an electronic patient diary (EPD) to record axillary temperature daily in the morning and evening. All temperature measurements during the study should be made with the same thermometer. The patient should bring the thermometer used for measurements to the health center visit. In addition, the patient should also use the EPD to record symptoms, if any, time of administration of the antipyretic dose, and any worsening of his/her condition (if applicable) to assess safety and record adverse events.
The investigator teaches the patient how to complete the diary at Visit 1. The EPD is available for completion throughout the patient's participation in the study.
An unscheduled visit may be made during the study if the patient's condition worsens or at the discretion of the investigator.
If clinical cure is not achieved by 15±1 days, the patient ends participation in the study because he or she has reached the study endpoint. The researcher determines the approach to further observation and treatment of the patient in accordance with current recommendations.
Subjects are permitted to take medications for concomitant medical conditions during the study, with the exception of medications listed in the Prohibited Concomitant Treatments section.
- Conditions
- Community-acquired Pneumonia, Pneumonia
- Being tested
- Raphamin, Placebo
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaphaminDrug
Also called MMH-407
Tablet for oral use.
PlaceboDrug
Tablet for oral use.
| Study group | Role | What they receive |
|---|---|---|
| Raphamin | Experimental | Oral administration, without food. The tablet should be held in the mouth until complete dissolution.
On the first day 8 tablets are administered using the following scheme: 1 tablet every 30 minutes in the first 2 hours (5 tablets in total within 2 hours), followed by three more tablets at regular intervals during the rest of the day. From day 2 onwards, 1 tablet taken 3 times daily. The treatment period is 7 days. Receives: Drug: Raphamin |
| Placebo | Placebo comparator | Oral administration, without food. The tablet should be held in the mouth until complete dissolution.
Placebo is administered according to the Raphamin regimen for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinical cure at the test of cure (TOC) visit
Percentage of patients with clinical cure at the TOC visit (on day 8 after randomization based on the physician's assessment of clinical symptoms).
Measured: On 8 days
Secondary outcomes (1)
Average duration of antibacterial therapy
Average duration of antibacterial therapy in two groups
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Dec 2023
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263881
- Sponsor's protocol ID
- MMH-407-009
- Status last verified
- Apr 2025
- First submitted
- 9 Feb 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT06263881
- Acronym / sponsor ID
- MMH-407-009
- Conditions
- Community-acquired Pneumonia, Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.
Detailed description
Design: a multicenter, double-blind, placebo-controlled, randomized in parallel-group trial.
The study enrolls male and female outpatients aged 18 to 65 years with typical symptoms of community-acquired pneumonia (CAP): axillary body temperature ≥38.00C, acute cough, shortness of breath (dyspnea), chest pain when breathing, fatigue, night sweats. Symptoms are associated with previous upper respiratory tract infection or acute bronchitis. The investigator assesses a prognosis and determines where the patient will receive treatment using the CRB-65 score which includes estimation of Confusion, Respiratory rate, Blood pressure, and Age (≥ 65 years) (min "0", max "4" points; only estimation "0" points is indication for outpatient treatment).
At the first visit (day 1), after signing the patient information sheet and informed consent form for participation in a clinical trial, the investigator collects complaints and medical history, conducts a physical examination and assessment of vital signs, and measures capillary blood oxygen saturation (SpO2), records comorbidities and concomitant therapies, collects blood samples for laboratory tests, and orders a dual-view chest X-ray or chest CT scan. If X-ray/CT shows no changes in the lungs or changes that are not typical for pneumonia, the patient is not included in the clinical trial. The investigator determines a therapeutic approach in compliance with the current standards.
At the first visit (day 1), patients are randomized to one of two treatment groups: patients in Group 1 receive Amoxicillin + Clavulanic acid (Amoxiclav) and Rafamine for 7 days; patients in Group 2 take Amoxiclav and Placebo for 7 days. All patients are provided with the drug Amoxiclav. In addition, all patients are provided with the antipyretic drug Paracetamol and a classic mercury-free thermometer to measure axillary temperature.
A second visit (3/4 days) is carried out 48-72 hours after the start of treatment to assess the effectiveness and safety of the initial course of antibiotic therapy. The investigator collects complaints, performs physical examination, and evaluates the vital signs and SpO2 level. If there is no response to initial antibiotic therapy, the decision about the therapeutic approach is made by the investigator. If hospitalization occurs, the patient ends participation in the study because he or she has reached the study endpoint.
If antibiotic therapy is effective, it is continued for 7 days. After 7 days of treatment, a third visit is carried out (day 8), at which the researcher collects the patient's complaints, conducts a physical examination and assessment of vital signs, measures SpO2 and prescribes a clinical blood test. If the patient meets the criteria for sufficiency of antibiotic therapy, the investigator stops prescribing the antibiotic.
If a positive response to the first course of antibiotic therapy is achieved, the patient continues to participate in the study. The patient is observed for 7 days. On day 15±1, the fourth visit is carried out, during which the researcher collects the patient's complaints, conducts a physical examination and assesses vital signs, measures SpO2 and prescribes a follow-up X-ray/CT scan. The patient returns the study drug and the investigator performs a compliance calculation. In total, patients are observed for 15 days.
The study uses an electronic patient diary (EPD) to record axillary temperature daily in the morning and evening. All temperature measurements during the study should be made with the same thermometer. The patient should bring the thermometer used for measurements to the health center visit. In addition, the patient should also use the EPD to record symptoms, if any, time of administration of the antipyretic dose, and any worsening of his/her condition (if applicable) to assess safety and record adverse events.
The investigator teaches the patient how to complete the diary at Visit 1. The EPD is available for completion throughout the patient's participation in the study.
An unscheduled visit may be made during the study if the patient's condition worsens or at the discretion of the investigator.
If clinical cure is not achieved by 15±1 days, the patient ends participation in the study because he or she has reached the study endpoint. The researcher determines the approach to further observation and treatment of the patient in accordance with current recommendations.
Subjects are permitted to take medications for concomitant medical conditions during the study, with the exception of medications listed in the Prohibited Concomitant Treatments section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raphamin | Experimental | Drug: RaphaminOral administration, without food. The tablet should be held in the mouth until complete dissolution. On the first day 8 tablets are administered using the following scheme: 1 tablet every 30 minutes in the first 2 hours (5 tablets in total within 2 hours), followed by three more tablets at regular intervals during the rest of the day. From day 2 onwards, 1 tablet taken 3 times daily. The treatment period is 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboOral administration, without food. The tablet should be held in the mouth until complete dissolution. Placebo is administered according to the Raphamin regimen for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients aged 18-65 years.
- The diagnosis of community-acquired pneumonia presupposes that the patient has focal infiltration of the lung tissue, confirmed by imaging (X-ray/CT), and the presence of at least two clinical symptoms:
- а) acute fever at the onset of the disease (axillary temperature ≥ 38.0°C); b) wet cough; c) physical signs (crepitus/wheezing, bronchial breathing sounds, local dullness to percussion); d) leukocytosis >10×10^9/L and/or shift of band neutrophils (>10%).
- SpO2 ≥95% according to pulse oximetry.
- Overall CRB-65 score "0" points.
Key exclusion criteria (23 listed)
- Any indications for patient hospitalization.
- Suspected infiltrative pulmonary tuberculosis.
- Medical history of/suspected malignant neoplasm of any location, including primary lung cancer and metastases to the lung parenchyma.
- Suspected pulmonary embolism and pulmonary infarction.
- Medical history of chronic obstructive pulmonary disease, bronchial asthma, chronic respiratory failure.
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 |
|---|---|---|
| RaphaminAlso: MMH-407Tablet for oral use. | Drug | Raphamin |
| PlaceboTablet for oral use. | Drug | Placebo |
Primary outcome
Percentage of patients with clinical cure at the test of cure (TOC) visit
Time frame: On 8 days
Percentage of patients with clinical cure at the TOC visit (on day 8 after randomization based on the physician's assessment of clinical symptoms).
1 secondary outcome
Average duration of antibacterial therapy
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
38 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 Raphamin in people with Community-acquired Pneumonia and Pneumonia, run by Materia Medica Holding at 38 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 7 inclusion and 23 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 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients with clinical cure at the test of cure (TOC) visit (time frame: On 8 days). 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 4 Apr 2025.