Clinical efficacy of sitafloxacin-colistin-meropenem and colistin-meropenem among multidrug-resistant Acinetobacter baumannii hospital-acquired pneumonia (HAP) / ventilator-associated pneumonia (VAP) patients in one super-tertiary hospital in Bangkok, Thailand, a randomized controlled trial
- Conditions
- A. baumannii infection VAP, implicated in 3-7% of cases, leading to an increased mortality rate.Acinetobacter baumannii HAP/VAP, carbapenem-resistant, multidrug-resistant, sitafloxacin
- Registration Number
- TCTR20221221001
- Lead Sponsor
- Rajavithi Hospital
- Brief Summary
For the primary outcome among two groups, the overall 7-day mortality was 7.5% in the intervention groups and 2.7% in the control group, with no statistically significant difference. As well, 14-day mortality showed no statistically significant difference between the two groups (10% VS 10.8%, P 1.0). For the secondary outcomes, the clinical response was significantly higher in the sitafloxacin-colistin-meropenem group, compared to the colistin-meropenem group by intention to treat (87.5% VS 62.2%; P 0.016).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 81
patients aged over 18 years who were diagnosed with CRAB HAP/VAP.
1.Sputum culture: colistin-resistant A. baumannii strains
2.Other organ sites of A. baumannii infection
3.Acute kidney injury or chronic kidney disease stage 3 or above
4.Liver failure
5.History of fluoroquinolone allergy
6.Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mortality 7, 14-day after treatment mortality rate
- Secondary Outcome Measures
Name Time Method Clinical response 3, 7-day after treatment symptoms and signs (defervescence, decreasing FiO2, successful mechanical ventilator weaning), laboratory values, and organ function markers (e.g., APACHE II score, qSOFA score)