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Compares treatment options for Leukemia
Official title Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies/Receiving Cellular Therapies and Fever
ClinicalTrials.gov ID: NCT07051525
What this study is testing
What is Early antibiotic cessation alert?
Early antibiotic cessation alert is an investigational medicine, being studied as a potential treatment for leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Often, there is no bacterial cause for fever found, and in the setting of a well patient with resolved fever, some studies have shown it to be safe to cease antibiotic therapy which was commenced at the onset of fever.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients ( ≥18 years) who are receiving either:
- Conditioning chemotherapy for an autologous or allogeneic haematopoietic cell transplant or CAR T cell therapy, OR
- Induction remission chemotherapy for acute leukaemia, AND develop fever ( ≥38degC) between time of initiation of chemotherapy/conditioning...
You likely can't join if
- \- Prolonged fever prior to defervescence (documented daily temperature ≥38.0°C for ≥ 5 days)
- Documented positive blood culture for bacteria since onset of fever episode and prior to randomisation
- Documented other infection (clinically or microbiologically defined) requiring antibacterial treatment
- Grade 2 or higher mucositis (WHO) or neutropenic enterocolitis
- Clinically unstable and/or admission to ICU at time of potential randomization
- Within 28 days of last randomization
See the full eligibility criteria
- Adult patients ( ≥18 years) who are receiving either:
- Conditioning chemotherapy for an autologous or allogeneic haematopoietic cell transplant or CAR T cell therapy, OR
- Induction remission chemotherapy for acute leukaemia, AND develop fever ( ≥38degC) between time of initiation of chemotherapy/conditioning administration and ANC recovery to ≥500 cells/mm3 post the ANC nadir, AND fever...
- \- Prolonged fever prior to defervescence (documented daily temperature ≥38.0°C for ≥ 5 days)
- Documented positive blood culture for bacteria since onset of fever episode and prior to randomisation
- Documented other infection (clinically or microbiologically defined) requiring antibacterial treatment
- Grade 2 or higher mucositis (WHO) or neutropenic enterocolitis
- Clinically unstable and/or admission to ICU at time of potential randomization
- Within 28 days of last randomization
- Prior randomization during current chemotherapy/conditioning cycle
- Pregnant or breastfeeding
- Currently being treated for CRS Grade 3 or 4, and/or ICANS Grade 3 or 4 (defined as per ASTCT Consensus Guidelines, Lee et al)
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. 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 ClinicalTrials.gov; the study team decides eligibility.