Early Oral Switch for Uncomplicated Gram-negative Bacteraemia
ConditionGram-negative Bacteraemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTan Tock Seng Hospital
About this trial
Current management of uncomplicated Gram-negative bacteraemia entails prolong intravenous (IV) antibiotic therapy with limited evidence to guide oral conversion. This trial aim to evaluate the clinical efficacy and economic impact of early switch to oral antibiotics (within 72 hours from index blood culture collection) versus continuing standard of care IV therapy (for at least another 24 hours post-randomisation) for clinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
One or more set(s) of blood cultures positive for Gram-negative bacteria (GNB) associated with evidence of infection
Able to be randomised within 72 hours of index blood culture collection
Age ≥18 years (≥21 in Singapore)
Latest Pitt bacteraemia score <4
Disqualifiers
Undrained abdominal abscess, deep seated intra-abdominal infection and other unresolved abdominal sources requiring surgical intervention
Central nervous system abscess (patients with focal neurology should have cranial CT prior to enrolment)
Undrained moderate-to-severe hydronephrosis
Necrotising fasciitis
Trial design
Design model
Parallel
Treatments tested in this trial
Oral fluoroquinolones (most commonly, ciprofloxacin) or oral trimethoprim-sulfamethoxazole
DrugClinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia randomised to the intervention arm will immediately be switched to oral antibiotics (within 72 hours from index blood culture collection)
Standard of care intravenous antibiotics (e.g. ceftriaxone, cefazolin)
DrugClinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia randomised to the standard arm will continue to receive an active intravenous antibiotic therapy for at least another 24 hours post-randomisation
Treatment groups
720 Participants
are divided into 2 treatment groupsGroup A: Early switch to oral antibiotic therapyExperimental treatment 1 intervention
Group B: Continuing intravenous antibiotic therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality at day 30 post-randomisation
Percentage of all-cause mortality at day 30 from the time of randomisation
Time frame
30 daysSecondary outcomes
1
All-cause mortality at day 14 and day 90 post-randomisation
Percentage of all-cause mortality at day 14 and day 90 from the time of randomisation
Time frame
14 days and 90 days, respectively2
Duration of survival (in days) up to day 90 post-randomisation
Hazard rate of survival from the time of randomisation until day 90
Time frame
90 days3
Number of days on IV antibiotic therapy in the total index hospitalisation until (i) hospital discharge and (ii) day 90
Median number of days on IV antibiotic therapy in the total index hospitalisation (including outpatient parenteral antibiotic therapy \[OPAT\]) for surviving participants from the time of randomisation until i) hospital discharge and ii) day 90
Time frame
Up to 90 days4
Number of days alive and free of antibiotics (i. for all antibiotics, and ii. for IV antibiotics) between the time of randomisation and day 90
Median total days alive and free from antibiotics (both oral and IV) for surviving participants; median total days alive and free from IV antibiotics for surviving participants; median proportion of days alive and free from antibiotics (both oral and IV) for surviving participants who discontinued the study; median proportion of days alive and free from IV antibiotics for surviving participants who discontinued the study; median proportion of days alive and free from antibiotics (both oral and IV) for non-surviving participants; and median proportion of days alive and free from IV antibiotics for non-surviving participants.
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tan Tock Seng Hospital
Lead sponsor
National University Hospital, Singapore
Collaborator
Singapore General Hospital
Collaborator
Changi General Hospital
Collaborator
Sengkang General Hospital
Collaborator
Ng Teng Fong General Hospital
Collaborator
University of Malaya
Collaborator
KPJ Ampang Puteri Specialist Hospital
Collaborator
Hospital Sungai Buloh, Selangor
Collaborator
Universiti Kebangsaan Malaysia Medical Centre
Collaborator
Taichung Veterans General Hospital
Collaborator
Melbourne Health
Collaborator
Gold Coast Hospital and Health Service
Collaborator
Princess Alexandra Hospital, Brisbane, Australia
Collaborator
Istanbul Medipol University Hospital
Collaborator
Rambam Health Care Campus
Collaborator
Sheba Medical Center
Collaborator
University Hospital of Pisa
Collaborator
IRCCS San Raffaele
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
Seoul National University Bundang Hospital
Collaborator
Samsung Medical Center
Collaborator
American University of Beirut Medical Center
Collaborator
University Hospital of Patras
Collaborator
Hospital del Mar
Collaborator
Singapore Clinical Research Institute
Collaborator
Consorzio per Valutazioni Biologiche e Farmacologiche
Collaborator
Source ClinicalTrials.gov