Clinical Trial: Co-trimoxazole as Maintenance Therapy for Meliodosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis

Brief Summary: This is a randomised, open-labelled, controlled trial to compare the efficacy and effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of melioidosis. The study population includes 800 patients with culture-confirmed melioidosis whom 12 weeks of oral eradication therapy have been completed with or without intravenous intensive antibiotics. Patients will be randomised to either stop the eradication treatment or continue current oral treatment for 8 more weeks. The study aim to optimise the regimen used to treat melioidosis for better compliance and reducing unnecessary use of antibiotics.

Detailed Summary: Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.
Sponsor: Khon Kaen University

Current Primary Outcome: 1-year non relapse rate [ Time Frame: 1 year ]

This is defined as clinical features of meliodosis after initial improvement, in association with cultures from any site positive for Burkhoderia pseudomallei. This can be any time point during or after stopping antibiotic treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Recurrence [ Time Frame: 1 year ]
    Recurrent clinical features of meliodosis treated as such but not confirmed by positive culture.
  • Treatment failure [ Time Frame: 9 weeks ]
    Clinical decision to change treatment according to inadequate response to therapy.
  • Mortality [ Time Frame: 1 year ]
  • Adverse Drug Reactions [ Time Frame: 9 weeks ]
    Adverse events that are caused by the drug including drug allergy.
  • Drug compliance [ Time Frame: 12 or 20 weeks ]
    This will be done by interviewing and pill counting.


Original Secondary Outcome: Same as current

Information By: Khon Kaen University

Dates:
Date Received: August 18, 2011
Date Started: August 2011
Date Completion: December 2020
Last Updated: March 2, 2017
Last Verified: March 2017