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Co-trimoxazole as Maintenance Therapy for Meliodosis

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Siriluck Anunnatsiri, Khon Kaen University
Sponsor:
Information provided by (Responsible Party):
Siriluck Anunnatsiri, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01420341
First received: August 18, 2011
Last updated: March 2, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Meliodosis Drug: Co-trimoxazole 12 Drug: Co-trimoxazole 20 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis

Resource links provided by NLM:


Further study details as provided by Siriluck Anunnatsiri, Khon Kaen University:

Primary Outcome 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 Outcome 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.


Estimated Enrollment: 800
Study Start Date: August 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Co-trimoxazole 12
Receive treatment with co-trimoxazole for 12 weeks.
Drug: Co-trimoxazole 12
Receive treatment with co-trimoxazole for 12 weeks.
Experimental: Co-trimoxazole 20
Receive treatment with co-trimoxazole for 20 weeks.
Drug: Co-trimoxazole 20
Receive treatment with co-trimoxazole for 20 weeks.

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

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420341

Contacts
Contact: Siriluck Anunnatsiri, MD +6643 363 664 asiril@kku.ac.th

Locations
Thailand
Khon Kaen Univerisity Recruiting
Khon Kaen, Thailand
Contact: Siriluck Anunnatsiri, MD    +6643 363 664      
Principal Investigator: Siriluck Anunnatsiri, MD         
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Siriluck Anunnatsiri, MD Khon Kaen Univerisity
  More Information

Responsible Party: Siriluck Anunnatsiri, MD, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01420341     History of Changes
Other Study ID Numbers: HE541074
Study First Received: August 18, 2011
Last Updated: March 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Siriluck Anunnatsiri, Khon Kaen University:
Meliodosis
Co-trimoxazole
Relapse

Additional relevant MeSH terms:
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 19, 2017