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