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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

Clinical efficacy of sitafloxacin-colistin-meropenem and colistin-meropenem among carbapenem-resistant and 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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221221001
Enrollment
80
Registered
2022-12-21
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

The participants were randomly assigned to receive a loading dose of 300 mg colistin, followed by 150 mg every 12 hours in combination with a high dose of meropenem, 2 g every 8 hours with 3-hour exte
Experimental Drug,Experimental Drug
sitafloxacin-colistin-meropenem ,colistin-meropenem

Sponsors

Rajavithi Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients aged over 18 years who were diagnosed with CRAB HAP/VAP.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
mortality 7, 14-day after treatment mortality rate

Secondary

MeasureTime frame
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)

Countries

Thailand

Contacts

Public ContactRajavithi Hospital

Rajavithi hospital

ihc@rajavithi.go.th6623548108

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026