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

Phase 4

Recruiting

• Conditions: Hospital Infections
• Interventions: Drug: Minocycline; Drug: Levofloxacin or Cotrimoxazole; Drug: Placebo

• Registration Number: NCT05575427
• Lead Sponsor: Mahidol University

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.

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 Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Study Start: 2022-11-24
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-07
• Last Update Posted: 2023-01-10
• Primary Completion: 2024-07-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination therapy with minocycline	Minocycline	Minocycline oral 50 mg per capsule 4 capsules oral stat then 2 capsules oral every 12 hours duration 7-28 days
Combination therapy with minocycline	Levofloxacin or Cotrimoxazole	Minocycline oral 50 mg per capsule 4 capsules oral stat then 2 capsules oral every 12 hours duration 7-28 days
Monotherapy plus placebo	Levofloxacin or Cotrimoxazole	Patients were treated Stenotrophomonas maltophilia infection with standard monotherapy either levofloxacin or Trimethoprim/sulfamethoxazole plus placebo
Monotherapy plus placebo	Placebo	Patients were treated Stenotrophomonas maltophilia infection with standard monotherapy either levofloxacin or Trimethoprim/sulfamethoxazole plus placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand