A pilot, single-centre, randomised control trial to determine if intensive phase antibiotics alone (intravenous antibiotics for 14 to 42 days) will result in the same clinical outcomes as standard antibiotics (intensive phase antibiotics plus eradication phase antibiotics (90 days of oral antibiotics)) in adults with melioidosis.
- Conditions
- MelioidosisInfection - Studies of infection and infectious agentsInfection - Other infectious diseases
- Registration Number
- ACTRN12622000225718
- Lead Sponsor
- Cairns Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Burkholderia pseudomallei cultured from a clinical specimen.
2. Able to be randomised during the intensive phase of treatment.
1. Suspected or confirmed central nervous system infection
2. Suspected or confirmed bone or joint infection
3. Suspected or confirmed endovascular infection
4. Moribund (expected to die in < 7 days)
5. Previous participation in the trial
6. Concurrent medical condition requiring trimethoprim/sulphamethoxazole prophylaxis
7. Concurrent medical condition requiring long term treatment with trimethoprim/sulphamethoxazole, doxycycline or amoxicillin/clavulanate
8. Known pregnancy
9. Potential participant not wishing to participate
10. Treating clinician unwilling to enrol potential participant into trial (e.g. concerns about safety of follow-up)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is an episode of recrudescence or relapse of culture-confirmed melioidosis post initial diagnosis of melioidosis. An Investigator will review a participant’s medical chart and contact them via telephone one year and two years following their initial diagnosis of melioidosis to ascertain if a documented culture-confirmed relapse has occurred.[Within two years post initial diagnosis of melioidosis.]
- Secondary Outcome Measures
Name Time Method