Efficacy of Combination Therapy With Minocycline for Treatment of Stenotrophomonas Maltophilia Infections

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05575427

Collaborator

(none)

112

Enrollment

Location

Arms

23.3

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hospital Infections	Drug: Minocycline Drug: Levofloxacin or Cotrimoxazole Drug: Placebo	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Phase 4 Randomized, Double blind, Placebo ControlledA Phase 4 Randomized, Double blind, Placebo Controlled

Masking:

Double (Participant, Investigator)

Masking Description:

Double blind, Placebo Controlled

Primary Purpose:

Treatment

Official Title:

Efficacy of Combination Therapy With Minocycline for Treatment of Stenotrophomonas Maltophilia Infections

Actual Study Start Date :

Nov 24, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination therapy with minocycline Minocycline oral 50 mg per capsule 4 capsules oral stat then 2 capsules oral every 12 hours duration 7-28 days	Drug: Minocycline The patients will receive minocycline oral between 7-28 days Other Names: Mino Drug: Levofloxacin or Cotrimoxazole The patients will receive levofloxacin or cotrimoxazole oral between 7-28 days Other Names: Cravit or Bactrim
Active Comparator: Monotherapy plus placebo Patients were treated Stenotrophomonas maltophilia infection with standard monotherapy either levofloxacin or Trimethoprim/sulfamethoxazole plus placebo	Drug: Levofloxacin or Cotrimoxazole The patients will receive levofloxacin or cotrimoxazole oral between 7-28 days Other Names: Cravit or Bactrim Drug: Placebo Capsule without active compound

Arm

Intervention/Treatment

Experimental: Combination therapy with minocycline

Minocycline oral 50 mg per capsule 4 capsules oral stat then 2 capsules oral every 12 hours duration 7-28 days

Drug: Minocycline

The patients will receive minocycline oral between 7-28 days

Other Names:

Mino

Drug: Levofloxacin or Cotrimoxazole

The patients will receive levofloxacin or cotrimoxazole oral between 7-28 days

Other Names:

Cravit or Bactrim

Active Comparator: Monotherapy plus placebo

Patients were treated Stenotrophomonas maltophilia infection with standard monotherapy either levofloxacin or Trimethoprim/sulfamethoxazole plus placebo

Drug: Levofloxacin or Cotrimoxazole

The patients will receive levofloxacin or cotrimoxazole oral between 7-28 days

Other Names:

Cravit or Bactrim

Drug: Placebo

Capsule without active compound

Outcome Measures

Primary Outcome Measures

mortality rate [participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
mortality rate of S. maltophilia infected patients receiving treatment at day 28

Secondary Outcome Measures

microbiological clearance [participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
we perform culture and staining to assess bacterial clearance after apply the study drug
adverse drug reactions [participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
we assess adverse drug reactions in 2 aspects; nephrotoxicity and hepatotoxicity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The infection caused by Stenotrophomonas maltophilia
The duration of treatment approximately between 7-28 days
The patients can take minocycline capsule via oral or nasogastric tube feeding.
The patients are anticipated to live more than 48 hrs after participation.
In case of an antibiotic drug administration for treatment Stenotrophomonas maltophilia beforehand, it should not exceed 48 hrs.
All of participants should be willing to join this project.