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

Mahidol University

Status and phase: Enrolling; Phase 4

Conditions: Hospital Infections

Treatments: Drug: Levofloxacin or Cotrimoxazole; Drug: Placebo; Drug: Minocycline

Study type: Interventional

Funder types: Other

Identifiers

NCT05575427

SI-CEU-01-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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.

Exclusion criteria

• Pregnancy and lactation
• The patients with active hepatitis
• The patients with history of minocycline allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

Combination therapy with minocycline

Experimental group

Description:

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

Treatment:

Drug: Minocycline

Drug: Levofloxacin or Cotrimoxazole

Monotherapy plus placebo

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Levofloxacin or Cotrimoxazole