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Completed

NCT Number: NCT01420341

Co-trimoxazole as Maintenance Therapy for Melioidosis

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.

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Key information

Conditions

Melioidosis Bacterial Infections Bacterial Infections and Mycoses Burkholderia Infections Disease Attributes Gram-Negative Bacterial Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Khon Kaen Univerisity

Khon Kaen, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 15 years
  • Culture-confirmed melioidosis
  • Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis
  • High likelihood of completing at least 6 months follow up
  • Willingness to participate in the study and written, informed consent obtained from the patient

Exclusion criteria

  • Pregnancy or breast feeding
  • Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment
  • Relapse melioidosis with at least 2 year symptom free period from last episode

Treatment and study plan

Co-trimoxazole 12

Drug

Receive treatment with co-trimoxazole for 12 weeks.

Co-trimoxazole 20

Drug

Receive treatment with co-trimoxazole for 20 weeks.

Primary outcomes

  1. 1-year non relapse rate

    Time frame: 1 year

    This is defined as clinical features of melioidosis 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 outcomes

  1. Clinical Recurrence

    Time frame: 1 year

    Recurrent clinical features of melioidosis treated as such but not confirmed by positive culture.

  2. Treatment failure

    Time frame: 9 weeks

    Clinical decision to change treatment according to inadequate response to therapy.

  3. Mortality

    Time frame: 1 year

  4. Adverse Drug Reactions

    Time frame: 9 weeks

    Adverse events that are caused by the drug including drug allergy.

  5. Drug compliance

    Time frame: 12 or 20 weeks

    This will be done by interviewing and pill counting.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2011
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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