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.
Short course antibiotic therapy for melioidosis treatment (SCATMAN) pilot trial
Cairns Hospital
60 participants
Apr 6, 2022
Interventional
Conditions
Summary
Melioidosis, an infection caused by the bacterium Burkholderia pseudomallei, can affect any organ and be rapidly fatal. The management of melioidosis is complex; antibiotic therapy occurs in two phases – an intensive phase of intravenous antibiotics followed by an eradication phase of oral antibiotics. Even with effective antibiotics, melioidosis can recur. As adhering to prolonged oral antibiotics is challenging, melioidosis treatment guidelines have evolved to recommend a longer intensive phase. This has resulted in excellent cure rates and recurrence is now uncommon, even in people who take no oral antibiotics at all. This pilot randomised control trial will investigate if oral antibiotics are still needed in the treatment of melioidosis and aims to provide initial data to support a larger, randomised control trial. We will recruit 60 participants with melioidosis and allocate them to either standard therapy or short course therapy (intravenous antibiotics only). Participants will be contacted weekly for 90 days and at one and two years to assess for disease recurrence. We hypothesise that with prolonged intravenous antibiotics, further oral antibiotics are no longer required to cure melioidosis and prevent recurrence.
Eligibility
Inclusion Criteria2
- Burkholderia pseudomallei cultured from a clinical specimen.
- Able to be randomised during the intensive phase of treatment.
Exclusion Criteria10
- Suspected or confirmed central nervous system infection
- Suspected or confirmed bone or joint infection
- Suspected or confirmed endovascular infection
- Moribund (expected to die in < 7 days)
- Previous participation in the trial
- Concurrent medical condition requiring trimethoprim/sulphamethoxazole prophylaxis
- Concurrent medical condition requiring long term treatment with trimethoprim/sulphamethoxazole, doxycycline or amoxicillin/clavulanate
- Known pregnancy
- Potential participant not wishing to participate
- Treating clinician unwilling to enrol potential participant into trial (e.g. concerns about safety of follow-up)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
All treatment will occur at Cairns Hospital (either within the hospital or through the hospital in the home service) or at a regional hospital in Far North Queensland if a person requires on going non-tertiary level hospital care. Short course therapy: Intravenous meropenem or ceftazidime, chosen at the discretion of the treating clinician, adjusted for renal function and dosed in accordance with the Australian Therapeutic Guidelines for 14 to 42 days as determined by the treating infectious diseases clinician. The duration of intravenous phase will be determined by the antibiotic duration determining focus and the treating clinician will be encouraged to follow the 2020 Revised Darwin melioidosis guideline. Intravenous meropenem will be dosed at 1-2g three times per day, adjusted for renal function as determined by the treating clinician. Intravenous ceftazidime will be dosed at 2g four times a day, adjusted for renal function as determined by the treating clinician. For the purposes of outpatient parenteral antibiotic therapy, ceftazidime at a dose of 8g daily, adjusted for renal function as determined by the treating clinician, will be administered as a 24-hour intravenous infusion using an elastometric infusion device. To help ensure adherence, the elastometric infusion device will be administered and removed daily by a nurse trained in the use of elastometric devices. No eradication phase therapy will be given.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12622000225718