Gram-Negative Bacterial Infections Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of the Drug Fluorothiazinone (Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on Mechanical Ventilation
This study is designed to evaluate the clinical and antibacterial efficacy, safety and pharmacokinetics of the drug Fluorothiazinone compared to placebo to prevent nosocomial gram-negative bacterial infections with participation of patients on mechanical ventilation. The main objectives of this study are: - Evaluation of the clinical and antibacterial efficacy of the drug Fluorothiazinone in combination with standard measures for the prevention of nosocomial infections compared to placebo in combination with standard measures for the prevention of nosocomial infections for the prevention of nosocomial infections caused by bacterial gram-negative flora in patients on mechanical ventilation. - Evaluation of the safety and tolerability of the drug Fluorothiazinone in patients on mechanical ventilation. - Evaluation of the pharmacokinetics (in whole blood) of the drug Fluorothiazinone with a single daily dose of 2400 mg/day. Researchers will compare results for the treatment and the placebo arms.
Status | Not yet recruiting |
Enrollment | 234 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patient's written consent to participate in the study in accordance with the current legislation or the decision of the board in case of absence of consciousness of the patient. 2. Patients are at least 18 years old, male and female. 3. Patients who are in the ICU (intensive care unit). 4. Patients with: 4.1. Laboratory confirmed SARS-CoV-2 (Severe acute respiratory syndrome-related coronavirus-2) on screening (a patient's coronavirus infection can be confirmed either before admission to the hospital (for outpatient treatment) or when admitted to the hospital) by RT-PCR (reverse transcription polymerase chain reaction) AND severe community-acquired pneumonia in ICU with evidence of viral lung injury and symptoms of respiratory failure: - SpO2 (peripheral oxygen saturation) = 93%; - Lung changes of 3rd- to 4th-degree according to CT (results of computed tomography), consistent with viral involvement; OR 4.2. Acute stroke; OR 4.3. Acute heart failure: Cardiogenic shock of any cause, pulmonary edema, or acute decompensated chronic heart failure. 5. Patients who have been on ALV (artificial lung ventilation) for no more than 12 hours. 6. Patients who are according to the investigator are at high risk to be transferred to ALV within 72 hours of the initiation of the therapy. 7. All women of childbearing age and men with partners of childbearing age should agree to use an effective contraceptive methods (e.g., implants, infections, combination oral contraceptives, intrauterine device, abstinence, vasectomy or vasectomy partner) during the entire study. Exclusion Criteria: 1. The patient was not switched to ALV within 72 hours (3 days) after receiving the investigational drug. 2. People who have a bloodstream infection, identified during the screening. 3. A patient may terminate his/her participation in the study at any time for any reason and without any explanation. 3. The investigator may also decide to terminate the patient's participation at any time if it is required due to the patient's condition. 4. The sponsor or the regulator may also request the trial to be terminated early, either due to how the trial was conducted, or due to application safety data, or other reasons. 5. The main reasons why the patient may withdraw from the study are: - Refusal of the patient to participate in the study; - Development of an AE (adverse event) / SAE (serious adverse event) that prevents further study participation; - The occurrence of concomitant somatic diseases / symptoms or exacerbation of chronic diseases not related to the investigational drug (at the discretion of the medical investigator). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Comparative characteristics of colonization of the respiratory and urinary tracts | Comparative characteristics of colonization of the respiratory and urinary tracts by individual pathogens in patients on the MV. | Throughout the therapy period (14 days). | |
Other | Comparative assessment of the condition on the SOFA scale | Comparative assessment of the condition on the Sequential Organ Failure Assessment (SOFA) scale. Comparative assessment of the condition on the SOFA scale throughout the study. Score ranges from 0 (best) to 24 (worst) points. | Throughout the therapy period (14 days). | |
Other | Comparative assessment of the condition on the APACHE II scale | Comparative assessment of the condition on the Acute Physiology and Chronic Health Evaluation II (APACHE II) scale throughout the study. Calculates an integer score from 0 to 71 based on multiple measurements. Higher scores correspond to more severe disease and a higher risk of death. | Throughout the therapy period (14 days). | |
Primary | MV-associated pneumonia caused by gram-negative bacteria (72-120 hours from the moment of tracheal intubation and the start of the MV) | The proportion of patients in the study groups without clinically and microbiologically confirmed MV-associated pneumonia caused by gram-negative bacteria, which developed no earlier than 72 hours (3 days) and no later than 120 hours (5 days) from the moment of tracheal intubation and the start of the MV, in the absence of signs of pulmonary infection at the time of intubation. | Throughout the therapy period (14 days). | |
Secondary | Time from the beginning of the MV to the development of MV-associated pneumonia | The time from the beginning of the MV to the development of MV-associated pneumonia caused by gram-negative bacteria, confirmed clinically and microbiologically, in the study groups during the entire period of therapy. | Throughout the therapy period (14 days). | |
Secondary | Time from the beginning of the MV to the development of a bloodstream infection | The time from the beginning of the MV to the development of a bloodstream infection caused by gram-negative bacteria, confirmed microbiologically in the study groups during the entire period of therapy. | Throughout the therapy period (14 days). | |
Secondary | Time from the beginning of the MV to the development of urinary tract infection | The time from the beginning of the MV to the development of urinary tract infection caused by gram-negative bacteria, confirmed microbiologically in the study groups during the entire period of therapy. | Throughout the therapy period (14 days). | |
Secondary | Proportion of patients who developed urinary tract infection | The proportion of patients who developed urinary tract infection caused by gram-negative bacteria, confirmed microbiologically, in the study groups during the entire period of reception of the investigative drug (IMP). | Throughout the therapy period (14 days). | |
Secondary | Proportion of patients who did not develop MV-associated pneumonia | The proportion of patients who did not develop MV-associated pneumonia caused by gram-negative bacteria, confirmed clinically and microbiologically, in the study groups during the entire period of reception of the investigative drug (IMP). | Throughout the therapy period (14 days). | |
Secondary | Proportion of patients who have gram-negative bacteria | The proportion of patients who have gram-negative bacteria isolated from the respiratory tract, with no clinical picture of pneumonia. | Throughout the therapy period (14 days). | |
Secondary | Proportion of patients who developed a bloodstream infection (during the entire period of therapy) | The proportion of patients who developed a bloodstream infection caused by gram-negative microflora, confirmed microbiologically in the study groups during the entire period of therapy. | Throughout the therapy period (14 days). | |
Secondary | Proportion of patients who developed a bloodstream infection (after the patient was transferred to the MV) | The proportion of patients who developed a bloodstream infection caused by gram-negative microflora, confirmed microbiologically in the study groups after the patient was transferred to the MV. | Throughout the therapy period (14 days). | |
Secondary | Proportion of patients with septic complications | The proportion of patients with septic complications in the study groups during the entire period of therapy. | Throughout the therapy period (14 days). | |
Secondary | The proportion of fatal outcomes | The proportion of fatal outcomes in the study groups during the entire period of therapy. | Throughout the therapy period (14 days). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00723502 -
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
|
Phase 2 | |
Completed |
NCT00177814 -
Piperacillin as a Part of Antibiotic Streamlining in the Intensive Care Unit
|
||
Suspended |
NCT00563134 -
A Randomised Trial on the Saftely and Efficacy of GR270774 in the Treatment of Gram-negative Sepsis in Adult
|
N/A | |
Active, not recruiting |
NCT05171257 -
Quantifying Gram-negative Resistance to Empiric Therapy in the Intensive Care Unit
|
||
Completed |
NCT03160040 -
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Minocin® (Minocycline) for Infections Caused by Gram-negative Bacteria in a Real World Setting
|
||
Completed |
NCT02962934 -
An Observational Pharmacokinetic Sudy of Ceftolozane-Tazobactam in Intensive Care Unit in Patients With and Without CRRT
|
||
Enrolling by invitation |
NCT04055922 -
Comparison of Solid Organ Transplant
|
||
Completed |
NCT00490477 -
The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial
|
Phase 3 | |
Recruiting |
NCT04861922 -
Unfractioned Heparin for Treatment of Sepsis Caused by Abdominal Infection
|
Phase 3 | |
Completed |
NCT01732250 -
Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem
|
Phase 4 | |
Completed |
NCT00406198 -
Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis
|
Phase 4 | |
Recruiting |
NCT06086626 -
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
|
Phase 2 | |
Withdrawn |
NCT04785924 -
Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections
|
Phase 4 | |
Completed |
NCT02285075 -
Temocillin Pharmacokinetic in Hemodialysis
|
Phase 4 | |
Completed |
NCT03182504 -
A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
|
Phase 1 | |
Not yet recruiting |
NCT04917380 -
The Clinical Character,Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.
|
||
Terminated |
NCT05210387 -
Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections
|
N/A | |
Completed |
NCT03397914 -
Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
|
Phase 4 | |
Completed |
NCT02088840 -
Survey of Severe Infections by Gram Negative Bacteria in Patients Submitted to Stem Cell Transplant
|
||
Recruiting |
NCT01600768 -
Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients
|
N/A |