Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia

NCT06263881 | Completed Phase 3

• 1 other identifier: MMH-407-009
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 38

Brief Summary

Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.

Conditions

Community-acquired Pneumonia; Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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).

  On 8 days

Secondary Outcomes (1)

• Average duration of antibacterial therapy

  15 days

Other Outcomes (12)

• Proportions of patients with a positive response to the initial course of antibiotic therapy after 48-72 hours

  3 days

• Proportion of patients who discontinue antibiotic therapy after 7 days of treatment (based on physician assessment of clinical symptoms).

  7 days

• Proportion of patients who required a change in antibiotic 48-72 hours after initiation of therapy.

  3 days

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Raphamin DRUG

Tablet for oral use.

Also known as: MMH-407

Raphamin

Placebo DRUG

Tablet for oral use.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (38)

Aramil city hospital

Aramil, 624002, Russia

Location

Northern Medical Clinical Center named after N.A. Semashko Federal Medical and Biological Agency

Arkhangelsk, 163000, Russia

Location

Gatchina Clinical Interdistrict Hospital

Gatchina, 188300, Russia

Location

Ivanovo Clinical Hospital named after Kuvayevs

Ivanovo, 153025, Russia

Location

City Clinical Hospital # 9 of the Ministry of Health of the Udmurt Republic

Izhevsk, 426063, Russia

Location

Central City Clinical Hospital

Kaliningrad, 236005, Russia

Location

Kazan State Medical University/Department of Infectious Diseases

Kazan', 420012, Russia

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology

Krasnodar, 350063, Russia

Location

Central Research Institute of Epidemiology

Moscow, 111123, Russia

Location

First Moscow State Medical University named after I.M. Sechenov

Moscow, 119991, Russia

Location

Moscow Regional Research Clinical Institute named after. M.F. Vladimirsky

Moscow, 129110, Russia

Location

Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko

Nizhny Novgorod, 603093, Russia

Location

LLC "Persona group of companies"

Nizhny Novgorod, 603155, Russia

Location

Clinical Hospital # 4

Penza, 440067, Russia

Location

LLC "Professor's clinic"

Perm, 614070, Russia

Location

Nikolaevskaya hospital

Petergof, 198510, Russia

Location

LLC "4D Ultrasound Clinic"

Pyatigorsk, 357502, Russia

Location

Rostov Central District Hospital

Rostov, 152155, Russia

Location

St. Petersburg Research Institute of Phthisiopulmonology

Saint Petersburg, 191036, Russia

Location

LLC "Energy of Health"

Saint Petersburg, 194156, Russia

Location

LLC "Medical center "Reavita Med SPb"

Saint Petersburg, 194354, Russia

Location

LLC "Medical Clinic"

Saint Petersburg, 194356, Russia

Location

City Polyclinic # 112

Saint Petersburg, 195427, Russia

Location

LLC "Zvezdnaya Clinic"

Saint Petersburg, 196158, Russia

Location

City Pokrovskaya Hospital

Saint Petersburg, 199106, Russia

Location

City Polyclinic # 4

Saint Petersburg, 199178, Russia

Location

LLC "Meili"

Saint Petersburg, 199406, Russia

Location

Medical University "Reaviz"

Samara, 443001, Russia

Location

Samara State Medical University/Department of General and Clinical Microbiology, Immunology and Allergology

Samara, 443099, Russia

Location

Smolensk State Medical University

Smolensk, 214019, Russia

Location

LLC "Scientific Medical Center of General Therapy and Pharmacology"

Stavropol, 355000, Russia

Location

Bashkir State Medical University/Department of Internal Medicine

Ufa, 450008, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432017, Russia

Location

Regional Clinic Hospital

Vladimir, 600023, Russia

Location

Voronezh Regional Clinical Hospital # 1

Voronezh, 394066, Russia

Location

Clinical Hospital # 2

Yaroslavl, 150030, Russia

Location

LLC "Medical Center for Diagnostics and Prevention Plus"

Yaroslavl, 150040, Russia

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Study Design

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

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 16, 2024
• Study Start: December 1, 2023
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (38)