Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients. It can acquire resistance to all classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may be the only therapeutic option. The addition of minocycline to colistin has been shown to be synergistic in vitro, and may be promising in vivo, but this combination has not been limited to case report or case series in comparison with colistin alone.
The purpose of this double-blind, randomized, parallel, placebo-controlled clinical trial is to assess whether the association of colistin and minocycline reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with colistin alone. The trial will enroll 94 patients from internal medicine ward and intensive care units (ICU) of an university care hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be randomly allocated to either colistin plus placebo (control arm) or colistin plus minocycline (experimental arm). Primary end point is overall mortality, defined as death occurring within 28 days from randomisation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
150 mg every 8 hours intravenously for at least 7 and up to a maximum of 28 days
200 mg every 12 hours orally for at least 7 and up to a maximum of 28 days
Capsule without active compound
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
RECRUITINGAll cause mortality
The study primary outcome is patient overall mortality, defined as death occurring during hospitalisation or within 28 days from randomization.
Time frame: 28 days
Microbiological eradication
Microbiological eradication is defined as the disappearance of A. baumannii in cultures from blood, bronchial aspirate, urines and drainage fluids.
Time frame: 28 days
Incidence of Renal toxicity (safety)
Renal toxicity is defined as decrease of creatinine clearance below 50 ml/min or \>50% reduction in the creatinine clearance relative to the baseline.
Time frame: 28 days
Incidence of Hepatic toxicity (safety)
Hepatic toxicity is defined as increase of direct bilirubin above 3 mg/dl.
Time frame: 28 days
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