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

NCT05575427 | Unknown Phase 4 DMC

• 1 other identifier: SI-CEU-01-2022
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital Infections

Keywords

Minocycline; Stenotrophomonas maltophilia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• microbiological clearance

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• adverse drug reactions

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

Combination therapy with minocycline

EXPERIMENTAL

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

Drug: Minocycline; Drug: Levofloxacin or Cotrimoxazole

Monotherapy plus placebo

ACTIVE COMPARATOR

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

Drug: Levofloxacin or Cotrimoxazole; Drug: Placebo

Interventions

Minocycline DRUG

The patients will receive minocycline oral between 7-28 days

Also known as: Mino

Combination therapy with minocycline

Levofloxacin or Cotrimoxazole DRUG

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

Also known as: Cravit or Bactrim

Combination therapy with minocycline; Monotherapy plus placebo

Placebo DRUG

Capsule without active compound

Monotherapy plus placebo

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (2)

• 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.

  PMID: 34058337 BACKGROUND

• 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.

  PMID: 32547125 BACKGROUND

MeSH Terms

Conditions

Cross Infection; cyclopia sequence

Interventions

Minocycline; Levofloxacin; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Adhiratha Boonyasiri, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuvanont Pongdumbun, MD

CONTACT

+66886822000; tuvanontp@gmail.com

Adhiratha Boonyasiri, MD

CONTACT

+6624192688; adhiratha.bon@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind, Placebo Controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Phase 4 Randomized, Double blind, Placebo Controlled

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: November 24, 2022
• Primary Completion: July 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)