Co-trimoxazole as Maintenance Therapy for Melioidosis

Melioidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420341
• Other study ID #: HE541074
• Secondary ID: project number 5
• Status: Completed
• Phase: Phase 4
• Start date: August 2011
• Est. completion date: June 21, 2019

Study information

• Verified date: September 2020
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melioidosis

Intervention

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

Locations

Country	Name	City	State
Thailand	Khon Kaen Univerisity	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year non relapse rate	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.	1 year
Secondary	Clinical Recurrence	Recurrent clinical features of melioidosis treated as such but not confirmed by positive culture.	1 year
Secondary	Treatment failure	Clinical decision to change treatment according to inadequate response to therapy.	9 weeks
Secondary	Mortality		1 year
Secondary	Adverse Drug Reactions	Adverse events that are caused by the drug including drug allergy.	9 weeks
Secondary	Drug compliance	This will be done by interviewing and pill counting.	12 or 20 weeks