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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 Recurrence

Treatment 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

Page last updated: August 23, 2015

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