Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.
- EligibilityCriteria: Inclusion Criteria:  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.  Exclusion Criteria:  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. 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). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult