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

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.

Study Overview

• Status: Recruiting
• Conditions: Hospital Infections
• Intervention / Treatment: Drug: Minocycline; Drug: Levofloxacin or Cotrimoxazole; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tuvanont Pongdumbun, MD; Phone Number: +66886822000; Email: tuvanontp@gmail.com
• Study Contact Backup: Name: Adhiratha Boonyasiri, MD; Phone Number: +6624192688; Email: adhiratha.bon@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Faculty of Medicine Siriraj Hospital, Mahidol University
    • Contact: Adhiratha Boonyasiri, MD; Phone Number: +6624192688; Email: adhiratha.bon@mahidol.ac.th
    • Principal Investigator: Adhiratha Boonyasiri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbiological clearance	we perform culture and staining to assess bacterial clearance after apply the study drug	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	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Adhiratha Boonyasiri, MD, Department of research, Faculty of Medicine Siriraj hospital, Mahidol University

Publications and helpful links

General Publications

• Junco SJ, Bowman MC, Turner RB. Clinical outcomes of Stenotrophomonas maltophilia infection treated with trimethoprim/sulfamethoxazole, minocycline, or fluoroquinolone monotherapy. Int J Antimicrob Agents. 2021 Aug;58(2):106367. doi: 10.1016/j.ijantimicag.2021.106367. Epub 2021 May 28.
• Insuwanno W, Kiratisin P, Jitmuang A. Stenotrophomonas maltophilia Infections: Clinical Characteristics and Factors Associated with Mortality of Hospitalized Patients. Infect Drug Resist. 2020 May 28;13:1559-1566. doi: 10.2147/IDR.S253949. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Stenotrophomonas maltophilia; Minocycline
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin; Trimethoprim, Sulfamethoxazole Drug Combination; Minocycline
• Other Study ID Numbers: SI-CEU-01-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No