Intravenous polymyxin B and colistin for carbapenem-resistant gram-negative infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective, observational post-marketing review of adult patients treated with intravenous polymyxin B or colistin methanesulfonate for carbapenem-resistant gram-negative bacterial infections at Tri-Service General Hospital in Taipei. Investigators will extract clinical and microbiological response, mortality, and safety outcomes, with particular attention to renal adverse events. Planned subgroup analyses will compare outcomes by site of infection (bacteremia versus hospital- or ventilator-associated pneumonia), causative pathogen, and baseline renal function. No experimental interventions are administered; the study analyzes existing medical records of treated patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient ≥ 18 years of age.
2. Patient diagnosed with bacterial pneumonia and/or bacteremia, or other physician judged serious infection (except urinary tract infection, UTI) caused by Carbapenem-Resistant Gram-Negative Bacteria (CR-GNB).

   CR-GNB: Resistant to at least one of the carbapenem antibiotics or produce a carbapenemase (an enzyme that can make them resistant to carbapenem antibiotics).

   Diagnosis Criteria of HABP/VABP:

   • Met the clinical diagnosis criteria for HABP/VABP. HABP: Acute bacterial pneumonia in a subject hospitalized for more than 48 hours or developing within 7 days after discharge from a hospital. Subject could have experienced acute respiratory failure and required mechanical ventilation for HABP.

   VABP: Acute bacterial pneumonia in a subject receiving mechanical ventilation via an endotracheal (or nasotracheal) tube for a minimum of 48 hours.
   * ≥ 1 of the following clinical features: new onset or worsening of pulmonary symptoms or signs, hypoxemia, need for acute changes in the ventilator support system to enhance oxygenation, new onset of or increase in suctioned respiratory secretions.
   * ≥ 1 of the following signs: documented fever, hypothermia, WBC ≥ 10,000 cells/mm3, WBC ≤ 4500 cells/mm3, \>15% immature neutrophils(bands)
   * CXR or lung CT: presence of new or progressive infiltrates suggestive of bacterial pneumonia.

   Diagnosis Criteria of BSI/Bacteremia: the BSI/sepsis category included bacteremia or sepsis caused by infections other than HABP/VABP, or UTI:
   * Documented BSI caused by a carbapenem-resistant Gram-negative pathogen; or
   * Systemic response to infection, meeting the clinical criteria of SIRS and an identified infection source (eg, severe skin infection, intra-abdominal infection) caused by a carbapenem-resistant Gram-negative pathogen.
3. Patient received intravenous polymyxin B or CMS treatment for ≥72 h.
4. Administration of polymyxin B or CMS within 7 days from the infection onset day.

Infection onset day: The date of specimen collection for index pathogen.

Exclusion Criteria:

1. Patient with bacteremia caused by urinary tract infection.
2. CR-GNB known to be resistant to polymyxin B or CMS.
3. Patient has infectious disease (s) caused by the following gram-negative bacteria which are known to have no response to polymyxin B and/or colistin treatment: Proteus spp., Providencia spp., Morganella spp., Serratia marcescens, Burkholderia spp., and Neisseria spp.
4. Intravenous administration of polymyxin B or colistin more than 28 days.
5. Both the treatment efficacy and safety could not be evaluated.

Where it's running

• Tri-Service General Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Angel Chen
• Email: angel_chen@tty.com.tw
• Phone: 886 2 26525999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating Fluorothiazinone for Preventing Bacterial Infections in Ventilated Patients

  This study is testing if a new drug called Fluorothiazinone can help prevent bacterial infections in patients on ventilators in the ICU.

  Recruiting at 2 sites Phase 2 Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Moscow, Moscow and 1 other locations · NCT06135350

• Impact of quick pneumonia panel on antibiotic choices for hospitalized adults

  This study tests whether a rapid pneumonia panel can help doctors choose better antibiotics sooner for adults with hospital‑acquired or ventilator‑associated pneumonia.

  Recruiting Hospital de Clinicas de Porto Alegre · Porto Alegre, Rio Grande do Sul · NCT07585604

• MP101 plus antibiotics in adults with acute Pseudomonas pneumonia

  This study tests whether a single IV dose of MP101, added to standard antibiotics, is safe and tolerable in adults with acute Pseudomonas aeruginosa pneumonia.

  Recruiting Phase 1 MicrobiotiX Co., Ltd · Seoul, Seodaemun-gu · NCT07492771

• Urine Pneumococcal Antigen Test in Children with Pneumonia

  This study tests a non-invasive urine test to see if it can detect pneumococcal pneumonia and identify serotypes in children under five in Malawi.

  Recruiting Liverpool School of Tropical Medicine · Blantyre · NCT07181200

• Jet versus vibrating mesh inhalation of polymyxin B for ventilated patients with carbapenem‑resistant Gram‑negative pneumonia

  This trial tests whether jet nebulizers or vibrating mesh nebulizers deliver inhaled polymyxin B more effectively for mechanically ventilated patients with carbapenem‑resistant Gram‑negative pneumonia.

  Recruiting Fujian Medical University Union Hospital · Fuzhou, Fujian · NCT07086391

• Improving treatment of pneumonia in children using lung ultrasound

  This study is testing if using lung ultrasound can help doctors treat pneumonia in kids better and reduce the need for unnecessary antibiotics.

  Recruiting at 8 sites Ecole Polytechnique Fédérale de Lausanne · Dakar, Dakar and 8 other locations · NCT06670833

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.