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

NCT ID: NCT05575427

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-24
• Study Completion Date: 2024-11-01

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.

Conditions

Hospital Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

The patients will receive minocycline oral between 7-28 days

Levofloxacin or Cotrimoxazole

Intervention Type: DRUG

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

Monotherapy plus placebo

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

Group Type: ACTIVE_COMPARATOR

Levofloxacin or Cotrimoxazole

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Capsule without active compound

Interventions

Minocycline

The patients will receive minocycline oral between 7-28 days

Intervention Type: DRUG

Levofloxacin or Cotrimoxazole

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

Intervention Type: DRUG

Placebo

Capsule without active compound

Intervention Type: DRUG

Other Intervention Names

Mino; Cravit or Bactrim

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adhiratha Boonyasiri, MD

Role: PRINCIPAL_INVESTIGATOR

Department of research, Faculty of Medicine Siriraj hospital, Mahidol University

Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Tuvanont Pongdumbun, MD

Role: CONTACT

tuvanontp@gmail.com

+66886822000

Adhiratha Boonyasiri, MD

Role: CONTACT

adhiratha.bon@mahidol.ac.th

+6624192688

Facility Contacts

Adhiratha Boonyasiri, MD

Role: primary

adhiratha.bon@mahidol.ac.th

+6624192688

References

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.

Reference Type: BACKGROUND

PMID: 34058337 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32547125 (View on PubMed)

Other Identifiers

SI-CEU-01-2022

Identifier Type: -

Identifier Source: org_study_id