NCT01420341

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
667

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

7.9 years

First QC Date

August 18, 2011

Last Update Submit

September 1, 2020

Conditions

Melioidosis

Keywords

MelioidosisCo-trimoxazoleRelapse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Clinical Recurrence

    1 year

  • Treatment failure

    9 weeks

  • Mortality

    1 year

  • Adverse Drug Reactions

    9 weeks

  • Drug compliance

    12 or 20 weeks

Study Arms (2)

Co-trimoxazole 12

ACTIVE COMPARATOR

Receive treatment with co-trimoxazole for 12 weeks.

Drug: Co-trimoxazole 12

Co-trimoxazole 20

EXPERIMENTAL

Receive treatment with co-trimoxazole for 20 weeks.

Drug: Co-trimoxazole 20

Interventions

Co-trimoxazole 12DRUG

Receive treatment with co-trimoxazole for 12 weeks.

Co-trimoxazole 12
Co-trimoxazole 20DRUG

Receive treatment with co-trimoxazole for 20 weeks.

Co-trimoxazole 20

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 15 years
  • Culture-confirmed melioidosis
  • Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis
  • High likelihood of completing at least 6 months follow up
  • Willingness to participate in the study and written, informed consent obtained from the patient

You may not qualify if:

  • Pregnancy or breast feeding
  • Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment
  • Relapse melioidosis with at least 2 year symptom free period from last episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen Univerisity

Khon Kaen, Thailand

Location

Related Publications (1)

  • Anunnatsiri S, Chaowagul W, Teparrukkul P, Chetchotisakd P, Tanwisaid K, Khemla S, Narenpitak S, Pattarapongsin M, Kongsawasd W, Pisuttimarn P, Thipmontree W, Mootsikapun P, Chaisuksant S, Chierakul W, Day NPJ, Limmathurotsakul D. A Comparison Between 12 Versus 20 Weeks of Trimethoprim-sulfamethoxazole as Oral Eradication Treatment for Melioidosis: An Open-label, Pragmatic, Multicenter, Non-inferiority, Randomized Controlled Trial. Clin Infect Dis. 2021 Dec 6;73(11):e3627-e3633. doi: 10.1093/cid/ciaa1084.

    PMID: 32725199DERIVED

MeSH Terms

Conditions

MelioidosisRecurrence

Condition Hierarchy (Ancestors)

Burkholderia InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Siriluck Anunnatsiri, MD

    Khon Kaen Univerisity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 19, 2011

Study Start

August 1, 2011

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)