NCT06263881

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Materia Medica Holding · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Community-acquired Pneumonia
• Pneumonia

Interventions

Type	Name	Description
DRUG	Raphamin	Tablet for oral use.
DRUG	Placebo	Tablet for oral use.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-03-19
• Completion: 2025-03-19
• First posted: 2024-02-16
• Last updated: 2025-04-04

Locations

38 sites across 1 country: Russia