Pneumonia
Conditions
Interventions
This is a randomized phase 1/2 clinical study with dose escalation to evaluate the safety and efficacy of the drug BromAc, a nebulizer solution consisting of a combination of the herbal compound brome
D08.811.277.656.262.500.096
Sponsors
Universidade Federal de Minas Gerais
Hospital das Clínicas - Faculdade de Medicina - UFMG
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: The participant or responsible party understands the procedures and requirements and is willing, and capable of providing informed consent for full participation in the study. Adults, male or female. Aged between 18 and 85 years at the time of consent with community-acquired pneumonia under mechanical ventilation admitted to the ICU. SARS-CoV-2 positive by rapid antigen testing in the case of COVID patients. Reported symptoms of severe respiratory illness (including fever or history of fever). The responsible party agrees and can fulfill all study procedures, including availability and contact information for follow-up visits. Patients may be intubated for up to 48 hours. Additionally, patients must have a secretor profile with vigorous mucous production at a capacity of 2mL of mucous per aspiration
Exclusion criteria
Exclusion criteria: Contraindication, or known hypersensitivity reaction to any elements of the proposed therapy. Currently participating in another therapeutic trial. Pregnant women. Severe ventilatory and hemodynamic instability that precludes procedures for aspiration or administration of the study medication, as defined by the attending medical team. Severely immunocompromised patients: solid organ or bone marrow transplant recipients within the past year, HIV/AIDS with CD4+ or = 250 mg of methylprednisolone or equivalent) or with another potent immunosuppressant (e.g., cyclophosphamide) in the last 28 days. Moribund participants or patients without a therapeutic proposal, with a prospect of death within the next 24 hours, as defined by the attending medical team
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the study, various metrics related to the safety and efficacy of the treatment will be assessed. Firstly, the frequency and severity of unsolicited adverse events (AEs) up to day 28 after treatment initiation will be recorded. This will allow us to monitor any unforeseen occurrences and evaluate their intensity. Additionally, solicited local and systemic reactions during the five days of treatment will be observed. This detailed analysis will provide insights into how the body reacts to the medication at different levels, enabling adjustments and improvements in the administration protocol. Throughout the study period, the frequency and relationship of any serious adverse events (SAEs) will be closely monitored, ensuring a proactive approach to identifying and managing potential complications. A special focus will be placed on adverse events of special interest (AESIs) up to day 28 after treatment initiation. These events, due to their specific clinical relevance, will be carefully documented and analyzed to ensure the safety of the participants. Finally, an additional analysis will include the modification of the viscosity rate of the tracheal aspirate collected in a standardized manner. By comparing baseline values (day 0) with those recorded on days 2 and 5 for each therapeutic arm, we will be able to assess the impact of the treatment on participants' respiratory condition compared to the negative control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will evaluate the rate of respiratory progression in patients using mechanical ventilation, being evaluated by the reduction of ventilatory parameters such as PEEP, FiO2, change of ventilation mode from assisted-controlled to spontaneous, and by the increase in the PAO2/FiO2 ratio;Compare the plasma and local concentration (tracheal aspirate) at baseline (day 0) and on days D2 and D5 of cytokines (including the measurement of IL-1b, IL-6, CXCL8, TNF, IL-17 and others) in participants treated with BromAc® or control participants;Compare the number of days to extubation, ICU discharge and hospital discharge in participants treated with BromAc or control participants | — |
Countries
Brazil
Contacts
Public ContactJordana Coelho-dos-Reis
Universidade Federal de Minas Gerais
Outcome results
None listed