Co-trimoxazole as Maintenance Therapy for Meliodosis

Overview

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.

Full Title of Study: “A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 21, 2019

Detailed Description

Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.

Interventions

  • Drug: Co-trimoxazole 12
    • Receive treatment with co-trimoxazole for 12 weeks.
  • Drug: Co-trimoxazole 20
    • Receive treatment with co-trimoxazole for 20 weeks.

Arms, Groups and Cohorts

  • Active Comparator: Co-trimoxazole 12
    • Receive treatment with co-trimoxazole for 12 weeks.
  • Experimental: Co-trimoxazole 20
    • Receive treatment with co-trimoxazole for 20 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Age > 15 years

2. Culture-confirmed melioidosis

3. Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis

4. High likelihood of completing at least 6 months follow up

5. Willingness to participate in the study and written, informed consent obtained from the patient

Exclusion Criteria

1. Pregnancy or breast feeding

2. Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment

3. Relapse melioidosis with at least 2 year symptom free period from last episode

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Khon Kaen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Siriluck Anunnatsiri, MD – Khon Kaen University
  • Overall Official(s)
    • Siriluck Anunnatsiri, MD, Principal Investigator, Khon Kaen Univerisity

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