Co-trimoxazole as Maintenance Therapy for Meliodosis
Information source: Khon Kaen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meliodosis
Intervention: Co-trimoxazole 12 (Drug); Co-trimoxazole 20 (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Khon Kaen University Official(s) and/or principal investigator(s): Siriluck Anunnatsiri, MD, Principal Investigator, Affiliation: Khon Kaen Univerisity
Overall contact: Siriluck Anunnatsiri, MD, Phone: +6643 363 664, Email: asiril@kku.ac.th
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 intravenous intensive antibiotics and 12 weeks of oral eradication therapy have been
completed. 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.
Clinical Details
Official title: A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 1-year non relapse rate
Secondary outcome: Clinical RecurrenceTreatment failure Mortality Adverse Drug Reactions Drug compliance
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age > 15 years
2. Culture-confirmed melioidosis
3. Satisfactory completion of intravenous therapy and currently on oral medication 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
Locations and Contacts
Siriluck Anunnatsiri, MD, Phone: +6643 363 664, Email: asiril@kku.ac.th
Khon Kaen Univerisity, Khon Kaen, Thailand; Recruiting Siriluck Anunnatsiri, MD, Phone: +6643 363 664 Siriluck Anunnatsiri, MD, Principal Investigator
Additional Information
Starting date: August 2011
Last updated: April 1, 2015
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