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 range
18 Years
Sex
ALL
See this in plain English?
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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);
. 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;