The objective of the study is to evaluate the efficacy of minocycline for treatment Stenotrophomonas maltophilia infection. The hypothesis of study is the combination therapy with minocycline would be better than the monotherapy for treatment Stenotrophomonas maltophilia infection.
* Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment. * After patient or their relatives are appreciated to join this project, patients will be randomly allocated to either levofloxacin or cotrimoxazole plus placebo (monotherapy plus placebo) or levofloxacin or cotrimoxazole plus minocycline (combination therapy). * Duration of treatment is determined by site and severity of infection, approximately 7-28 days. * Sample size calculation, by two independent proportions formula, the investigators estimate the mortality rate about 54 % in monotherapy group and mortality rate about 27 % in combination therapy with minocycline group, with 2-sided 95% Confidence interval; therefore,51 persons are needed each group. * The investigators estimate gather data about 112 persons. (56 participants with monotherapy and 56 participants with combination therapy (minocycline plus another antibiotic drug from intervention trial)) * The categorical variables are reported as frequencies and percentages, while continuous variables are reported as means ± standard deviations for normally distributed data and median ± range for non-normally distributed data. The data collected from patients are compared using Chi-square tests or Fisher's exact tests for categorical variables and using t-tests or Mann-Whitney U-tests for continuous variables. * During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
The patients will receive minocycline oral between 7-28 days
The patients will receive levofloxacin or cotrimoxazole oral between 7-28 days
Capsule without active compound
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
RECRUITINGmortality rate
mortality rate of S. maltophilia infected patients receiving treatment at day 28
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
microbiological clearance
we perform culture and staining to assess bacterial clearance after apply the study drug
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
adverse drug reactions
we assess adverse drug reactions in 2 aspects; nephrotoxicity and hepatotoxicity
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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