nctId: NCT06263881 id: MMH-407-009 briefTitle: Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia overallStatus: RECRUITING date: 2023-12-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-16 date: 2024-04-19 name: Materia Medica Holding class: INDUSTRY briefSummary: Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial. conditions: Community-acquired Pneumonia conditions: Pneumonia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 370 type: ESTIMATED name: Raphamin name: Placebo measure: Percentage of patients with clinical cure at the test of cure (TOC) visit measure: Average duration of antibacterial therapy measure: Proportions of patients with a positive response to the initial course of antibiotic therapy after 48-72 hours measure: Proportion of patients who discontinue antibiotic therapy after 7 days of treatment (based on physician assessment of clinical symptoms). measure: Proportion of patients who required a change in antibiotic 48-72 hours after initiation of therapy. measure: Time until a persistent decrease in body temperature ≤37.2ºС (according to the patient's diary). measure: Proportion of patients who required a second course of antibiotic therapy. measure: Proportion of patients who required hospitalization during 15 days of follow-up. measure: Number of antipyretic drug doses taken during 7 days of the initial course of antibacterial therapy (per patient). measure: Proportion of patients without infiltration on x-ray/CT 14 days after randomization. measure: The Presence of Adverse Events (AEs). measure: Changes in Vital Signs (Blood Pressure measured in mm Hg) measure: Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute) measure: Changes in Vital Signs (Respiratory Rate (Breathing Rate) measured in breaths per minute) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Medical Clinical Center named after N.A. Semashko Federal Medical and Biological Agency status: RECRUITING city: Arkhangelsk zip: 163000 country: Russian Federation name: Vadim Arkhipovsky, PhD, MD role: CONTACT name: Vadim Arkhipovsky, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 64.5401 lon: 40.5433 facility: Regional Clinical Hospital # 3 status: WITHDRAWN city: Chelyabinsk zip: 454018 country: Russian Federation lat: 55.15402 lon: 61.42915 facility: Ivanovo Clinical Hospital named after Kuvayevs status: RECRUITING city: Ivanovo zip: 153025 country: Russian Federation name: Svetlana Ushakova, PhD, MD role: CONTACT name: Svetlana Ushakova, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 56.99719 lon: 40.97139 facility: Central City Clinical Hospital status: RECRUITING city: Kaliningrad zip: 236005 country: Russian Federation name: Vladimir Rafalsky, Prof. role: CONTACT name: Vladimir Rafalsky, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.70649 lon: 20.51095 facility: Kazan State Medical University/Department of Infectious Diseases status: RECRUITING city: Kazan zip: 420012 country: Russian Federation name: Irina Kravchenko, MD, PhD role: CONTACT name: Irina Kravchenko, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.78874 lon: 49.12214 facility: Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology status: RECRUITING city: Krasnodar zip: 350063 country: Russian Federation name: Marina Avdeeva, Prof. role: CONTACT name: Marina Avdeeva, Prof. role: PRINCIPAL_INVESTIGATOR lat: 45.04484 lon: 38.97603 facility: Lomonosov Interdistrict Hospital named after. I.N. Yudchenko status: RECRUITING city: Lomonosov zip: 188531 country: Russian Federation name: Svetlana Mosolova, MD role: CONTACT name: Svetlana Mosolova, MD role: PRINCIPAL_INVESTIGATOR lat: 59.90612 lon: 29.77253 facility: Central Research Institute of Epidemiology status: RECRUITING city: Moscow zip: 111123 country: Russian Federation name: Antonina Ploskireva, PhD, MD role: CONTACT name: Antonina Ploskireva, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Moscow Regional Research Clinical Institute named after. M.F. Vladimirsky status: RECRUITING city: Moscow zip: 129110 country: Russian Federation name: Svetlana Erofeeva, MD, PhD role: CONTACT name: Svetlana Erofeeva, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko status: RECRUITING city: Nizhny Novgorod zip: 603093 country: Russian Federation name: Vladimir Nosov, MD, PhD role: CONTACT name: Vladimir Nosov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 56.32867 lon: 44.00205 facility: LLC "Persona group of companies" status: RECRUITING city: Nizhny Novgorod zip: 603155 country: Russian Federation name: Natalya Eremina, MD, PhD role: CONTACT name: Natalya Eremina, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 56.32867 lon: 44.00205 facility: LLC "Professor's clinic" status: RECRUITING city: Perm zip: 614070 country: Russian Federation name: Svetlana Teplykh, MD, PhD role: CONTACT name: Svetlana Teplykh, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.01046 lon: 56.25017 facility: LLC "4D Ultrasound Clinic" status: RECRUITING city: Pyatigorsk zip: 357502 country: Russian Federation name: Daria Saenko, MD role: CONTACT name: MD role: CONTACT name: Daria Saenko role: PRINCIPAL_INVESTIGATOR lat: 44.04861 lon: 43.05944 facility: St. Petersburg Research Institute of Phthisiopulmonology status: RECRUITING city: Saint Petersburg zip: 191036 country: Russian Federation name: Yana Startseva, MD role: CONTACT name: Yana Startseva, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Energy of Health" status: RECRUITING city: Saint Petersburg zip: 194156 country: Russian Federation name: Natalya Egorova, MD role: CONTACT name: Natalya Egorova, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Multidisciplinary Hospital # 2 status: WITHDRAWN city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: LLC "Medical Clinic" status: RECRUITING city: Saint Petersburg zip: 194356 country: Russian Federation name: Maxim Bushara, MD role: CONTACT name: Maxim Bushara, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Research Center Eco-Safety" status: WITHDRAWN city: Saint Petersburg zip: 196143 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: LLC "Zvezdnaya Clinic" status: RECRUITING city: Saint Petersburg zip: 196158 country: Russian Federation name: Artem Sergeenko, MD role: CONTACT name: Artem Sergeenko, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Pokrovskaya Hospital status: RECRUITING city: Saint Petersburg zip: 199106 country: Russian Federation name: Oleg Khmelnitsky, PhD, MD role: CONTACT name: Oleg Khmelnitsky, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Meili" status: RECRUITING city: Saint Petersburg zip: 199406 country: Russian Federation name: Irina Nesterovich, PhD, MD role: CONTACT name: Irina Nesterovich, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Samara State Medical University/Department of General and Clinical Microbiology, Immunology and Allergology status: RECRUITING city: Samara zip: 443099 country: Russian Federation name: Alexander Zhestkov, Prof. role: CONTACT name: Alexander Zhestkov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 53.20007 lon: 50.15 facility: Smolensk State Medical University status: RECRUITING city: Smolensk zip: 214019 country: Russian Federation name: Roman Kozlov, Prof. role: CONTACT name: Roman Kozlov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.7818 lon: 32.0401 facility: LLC "Scientific Medical Center of General Therapy and Pharmacology" status: RECRUITING city: Stavropol zip: 355000 country: Russian Federation name: Olga Ukhanova, Prof. role: CONTACT name: Olga Ukhanova, Prof. role: PRINCIPAL_INVESTIGATOR lat: 45.0428 lon: 41.9734 facility: Bashkir State Medical University/Department of Internal Medicine status: RECRUITING city: Ufa zip: 450008 country: Russian Federation name: Khalida Gantseva, Prof. role: CONTACT name: Khalida Gantseva, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.74306 lon: 55.96779 facility: Regional Clinic Hospital status: RECRUITING city: Vladimir zip: 600023 country: Russian Federation name: Mikhail Smirnov, MD role: CONTACT name: Mikhail Smirnov, MD role: PRINCIPAL_INVESTIGATOR lat: 56.13655 lon: 40.39658 facility: Voronezh Regional Clinical Hospital # 1 status: RECRUITING city: Voronezh zip: 394066 country: Russian Federation name: Natalya Kostina, PhD, MD role: CONTACT name: Natalya Kostina, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 51.67204 lon: 39.1843 facility: Clinical Hospital # 2 status: RECRUITING city: Yaroslavl zip: 150030 country: Russian Federation name: Andrey Arshinov, Prof. role: CONTACT name: Andrey Arshinov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: LLC "Medical Center for Diagnostics and Prevention Plus" status: RECRUITING city: Yaroslavl zip: 150040 country: Russian Federation name: Ekaterina Melnikova, MD, PhD role: CONTACT name: Ekaterina Melnikova, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 hasResults: False