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Meliodosis | Co-trimoxazole as Maintenance Therapy for Meliodosis

Meliodosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Meliodosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Co-trimoxazole 12Receive treatment with co-trimoxazole for 12 weeks.

Co-trimoxazole 20Receive treatment with co-trimoxazole for 20 weeks.

Study Status

Active, not recruiting

Start Date: August 2011

Completed Date: June 2019

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: 1-year non relapse rate

Secondary Outcome: Clinical Recurrence

Study sponsors, principal investigator, and references

Principal Investigator: Siriluck Anunnatsiri, MD

Lead Sponsor: Khon Kaen University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01420341

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