Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a simple pill replace IV drips for blood infections?

NCT ID NCT05199324

Disease control Sponsor: Tan Tock Seng Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests whether stable patients with a common blood infection (gram-negative bacteraemia) can safely switch from IV antibiotics to oral pills within 72 hours. Researchers will compare early oral therapy to continued IV treatment in 720 adults. The main goal is to see if survival rates at 30 days are similar between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oral fluoroquinolones (e.g., ciprofloxacin) or oral trimethoprim-sulfamethoxazole (Bactrim)
What this could lead to
If successful, this could show that switching to oral antibiotics early is as safe and effective as staying on IV therapy, potentially reducing hospital stays and treatment costs.
What could go wrong
This is a single-center trial, and results may not apply to all patients. The oral antibiotics may not work as well in sicker patients or those with hidden infection sources.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

720 people

The number who actually took part.

Started

Jun 2022

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. One or more set(s) of blood cultures positive for Gram-negative bacteria (GNB) associated with evidence of infection 2. Able to be randomised within 72 hours of index blood culture collection 3. Age ≥18 years (≥21 in Singapore) 4. Latest Pitt bacteraemia score \<4 5. Patient or legal representative is able to provide informed consent Exclusion Criteria: 1. Established uncontrolled focus of infection, including but not limited to: * 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 2. Complicated infections, including but not limited to: * Necrotising fasciitis * Empyema * Central nervous system infections and meningitis * Endocarditis / endovascular infections 3. Septic shock as defined by systolic blood pressure \<90 or mean arterial pressure \<70 mmHg despite adequate fluid resuscitation or need for inotropic/vasopressor support 4. Polymicrobial bacteraemia involving Gram-positive pathogens or anaerobes (defined as either growth of 2 or more different microorganism species in the same blood culture, or growth of different species in 2 or more separate blood cultures within the same episode \[\<48 hours\] and with clinical or microbiological evidence of the same source) 5. Bacteraemia is due to a vascular catheter or intravascular materials (e.g. pacing wire, vascular graft) that cannot be removed 6. Specific Gram-negative pathogens that cannot be effectively treated with fluoroquinolones or trimethoprim-sulfamethoxazole, including but not limited to, Burkholderia spp. and Brucella spp. 7. Index GNB with resistance to fluoroquinolones AND trimethoprim-sulfamethoxazole 8. Hypersensitivity to fluoroquinolones AND sulphur drugs as defined by history of rash, urticaria, angioedema, bronchospasm, circulatory collapse or significant adverse reaction following prior administration 9. Unable to consume or absorb oral medications for any reason or unsuitable for ongoing IV therapy (e.g. no intravenous access) 10. Severely immunocompromised in the opinion of the treating doctor, including but not limited to, medical conditions such as: * Active leukaemia or lymphoma * Aplastic anaemia * Bone marrow transplant within two years of transplantation or transplants of longer duration still on immunosuppressive drugs or with graft-versus-host disease * Congenital immunodeficiency * HIV/AIDS with CD4 lymphocyte count \<200 * Neutropenia or expected post-chemotherapy neutropenia within 14 days from the time of screening, defined as absolute neutrophil count \< 500 cells/μL 11. Women who are known to be pregnant or breast-feeding 12. Treatment is not with intent to cure the infection (i.e. palliative care) 13. Unable to collect patient's follow-up data for at least 30 days post-randomisation for any reason 14. Treating doctor deems enrolment into the trial is not in the best interest of the patient 15. Previous enrolment in this trial

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Gram-negative bacteraemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis gram-negative bacterial infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gram-negative bacteraemia

Contacts and locations

Locations

  • American University of Beirut Medical Center

    Beirut, 1107 2020, Lebanon

  • Changi General Hospital

    Singapore, Singapore, 529889, Singapore

  • Gold Coast University Hospital

    Southport, Queensland, 4215, Australia

  • Hospital Ampang

    Ampang, 68000, Malaysia

  • Hospital Universiti Kebangsaan Malaysia

    Kuala Lumpur, 56000, Malaysia

  • Hospital del Mar

    Barcelona, 08003, Spain

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola

    Bologna, 40138, Italy

  • IRCCS Hospital San Raffaele

    Milan, 20132, Italy

  • Medipol Mega University Hospital

    Istanbul, 34214, Turkey (Türkiye)

  • National University Hospital

    Singapore, Singapore, 119074, Singapore

  • Ng Teng Fong General Hospital

    Singapore, Singapore, 609606, Singapore

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Rambam Hospital

    Haifa, 3109601, Israel

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050, Australia

  • Samsung Medical Center

    Soeul, 06351, South Korea

  • Sengkang General Hospital

    Singapore, Singapore, 544886, Singapore

  • Seoul National University Bandang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Sheba Medical Center

    Ramat Gan, 5262000, Israel

  • Singapore General Hospital

    Singapore, Singapore, 169608, Singapore

  • Sungai Buloh Hospital

    Sungai Buloh, 47000, Malaysia

  • Taichung Veterans General Hospital

    Taichung, Xitun District, 407219, Taiwan

  • Tan Tock Seng Hospital

    Singapore, Singapore, 308433, Singapore

  • Universiti Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • University General Hospital of Patras

    Pátrai, 26504, Greece

  • University Hospital of Pisa

    Pisa, 56124, Italy