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Comparison of continuing intravenous antibiotic therapy with switching to oral antibiotics in clinically stable patients with blood infections caused by Gram-negative bacteria (INVEST study)
EU CTIS ID: 2024-517308-13-00
What this study is testing
To investigate if the early step-down to oral fluoroquinolones or trimethoprim-sulfamethoxazole will be clinically non-inferior to continuing IV antibiotic therapy in the primary outcome of 30-day all-cause mortality
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥1 set of blood cultures positive for 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
- Patient or legal representative is able to provide informed consent
You likely can't join if
- Established uncontrolled focus of infection (e.g. undrained abdominal abscess)
- Severely immunocompromised
- Women who are known to be pregnant or breast-feeding
- Treatment is not with intent to cure the infection (i.e. palliative care)
- Unable to collect patient’s follow-up data for at least 30 days post-randomisation
- Treating doctor deems enrolment into trial is not in the best interest of the patient
See the full eligibility criteria
- ≥1 set of blood cultures positive for 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
- Patient or legal representative is able to provide informed consent
- Established uncontrolled focus of infection (e.g. undrained abdominal abscess)
- Severely immunocompromised
- Women who are known to be pregnant or breast-feeding
- Treatment is not with intent to cure the infection (i.e. palliative care)
- Unable to collect patient’s follow-up data for at least 30 days post-randomisation
- Treating doctor deems enrolment into trial is not in the best interest of the patient
- Previous enrolment in this trial
- Complicated infections (e.g. necrotising fasciitis)
- Septic shock
- Polymicrobial bacteraemia
- Bacteraemia due to vascular catheter or intravascular materials that cannot be removed
- Specific Gram-negative pathogens that cannot be effectively treated with fluoroquinolones or trimethoprim-sulfamethoxazole (e.g. Burkholderia, Brucella)
- Index GNB with resistance to fluoroquinolones AND trimethoprim-sulfamethoxazole
- Hypersensitivity to fluoroquinolones AND sulpha drugs
- Unable to consume or absorb oral medications for any reason or unsuitable for ongoing IV therapy (e.g. no intravenous access)
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon
- Turkey
- Australia
- Taiwan
- Malaysia
- Israel
- Korea, Republic of
- United Kingdom
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon; Turkey; Australia; Taiwan; Malaysia; Israel and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.