A Clinical Trial for the Treatment of Carbapenem Resistant Gram-negative Bacterial Infection With… (NCT06198764) | Clinical Trial Compass
UnknownPhase 3
A Clinical Trial for the Treatment of Carbapenem Resistant Gram-negative Bacterial Infection With Colistimethate Sodium for Injection
China80 participantsStarted 2023-07-06
Plain-language summary
A clinical study to evaluate Colistimethate Sodium for Injection combination with Meropenem versus Coly-Mycin® M Parenteral combined with Meropenem in the treatment of Carbapenem resistant gram-negative bacteria infection. A total of 80 patients will be enrolled in the study.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with acute pulmonary parenchymal infection who have been hospitalized for more than 48 hours or discharged for less than 7 days, or have received mechanical ventilation through oral or nasal tracheal intubation for at least 48 hours;
✓. Chest X-ray examination (or computed tomography) obtained within 72 hours before randomization shows new infiltrating lesions or progression of existing lesions;
✓. Individuals with at least 2 of the following clinical symptoms/signs:
✓. New occurrence cough；
✓. Produce purulent sputum or tracheal secretions；
✓. The auscultation results are accord with pneumonia/lung consolidation (such as wet rale, dry rale, bronchial breath sound, egophony, dull percussion note);
✓. Difficulty in breathing, shortness of breath (respiratory rate\>25 breaths/minute), or hypoxemia (oxygen saturation\< 90% when breathing indoor air at standard atmospheric pressure or arterial blood oxygen partial pressure (PaO2) obtained through arterial blood gas (ABG)\<60 mmHg);
✓. The oxygenation index (arterial partial pressure of oxygen/percentage of inhaled oxygen concentration (PaO2/FiO2)) deteriorates, requiring urgent changes in ventilator support status or changes in positive end expiratory pressure ventilation volume.
Exclusion criteria
✕. Patients with lung diseases that can interfere with treatment response evaluation, (such as cystic fibrosis, granulomatous diseases, pulmonary fungal infections, or recent pulmonary embolism);
What they're measuring
1
Clinical cure rate (mITT)
Timeframe: At TOC visit, which is 7-14 days after the end of treatment.
Trial details
NCT IDNCT06198764
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
. Individuals with lung abscess, empyema, or obstructive pneumonia;
✕. New York Heart Association (NYHA) Grade III-IV heart failure
✕. Lung or heart transplant recipients.
✕. Subjects suspected or confirmed to have prostatitis;
✕. Renal transplant recipients;
✕. Individuals with ileal loops;
✕. Individuals who may continue to receive prophylactic treatment with antibiotics during clinical trials, such as those with bladder ureteral reflux;