Neutropenia, FebrilePhase 3DALFENNCT03003273
Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: -DALFEN Study
A Phase 3 study testing stoppage of antibiotics, amoxycillin/clavulanic acid and levofloxacin in people with Neutropenia, Febrile and Pediatric Cancer, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Neutropenia, Febrile, Pediatric Cancer
- What is being tested?
- stoppage of antibiotics, amoxycillin/clavulanic acid and levofloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All pediatric febrile neutropenia patients treated on outpatient basis
- Age 3 years - 18 years
- Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )
- Afebrile for at least 24 hours, on intra-venous antibiotics
Who cannot join
- Bone marrow involvement in solid tumor
- Already enrolled once, in previous episode
- On antibiotics prophylaxis
- Retroviral positive patients
- Patient undergone stem cell transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: a Randomized Controlled Study -DALFEN Study
Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or reappearance of fever within follow-up of ≤ 10 days.
- Conditions
- Neutropenia, Febrile, Pediatric Cancer
- Being tested
- stoppage of antibiotics, amoxycillin/clavulanic acid, levofloxacin
- Medical subject headings
- Febrile Neutropenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stoppage of antibioticsOther
antibiotics will be stopped in arm - A on randomization, once child is afebrile for at least 24 hours and fulfills the inclusion criteria.
amoxycillin/clavulanic acidOther
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
levofloxacinOther
In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
| Study group | Role | What they receive |
|---|---|---|
| arm (A) - stoppage of antibiotics | Experimental | patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A. Receives: Other: stoppage of antibiotics |
| arm (B) - oral antibiotics till ANC ≥ 500 | Active comparator | patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. Receives: Other: amoxycillin/clavulanic acid; Other: levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment is considered to be successful if the following is attained without changing the regimen - Patient remains afebrile till recovery of ANC ≥500 •Measure of effect: Proportion of patients afebrile in each arm
Measured: till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days
Secondary outcomes (1)
Rate of re-admission
Measured: till ANC ≥ 500 or reappearance of fever during the period ≤10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutropenia, FebrileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AKASH KUMAR, All India Institute of Medical Sciences
- Investigators
- Sameer Bakhshi, Professor, Study director, Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003273
- Sponsor's protocol ID
- IECPG-164
- Acronym
- DALFEN
- Status last verified
- Jan 2019
- First submitted
- 13 Dec 2016
- Last updated
- 1 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: a Randomized Controlled Study -DALFEN Study
- ClinicalTrials.gov ID
- NCT03003273
- Acronym / sponsor ID
- DALFEN / IECPG-164
- Conditions
- Neutropenia, Febrile, Pediatric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or reappearance of fever within follow-up of ≤ 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm (A) - stoppage of antibiotics | Experimental | Other: stoppage of antibioticspatients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A. |
| arm (B) - oral antibiotics till ANC ≥ 500 | Active comparator | Other: amoxycillin/clavulanic acid, Other: levofloxacinpatients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All pediatric febrile neutropenia patients treated on outpatient basis
- Age 3 years - 18 years
- Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )
- Afebrile for at least 24 hours, on intra-venous antibiotics
Key exclusion criteria (5 listed)
- Bone marrow involvement in solid tumor
- Already enrolled once, in previous episode
- On antibiotics prophylaxis
- Retroviral positive patients
- Patient undergone stem cell transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stoppage of antibioticsantibiotics will be stopped in arm - A on randomization, once child is afebrile for at least 24 hours and fulfills the inclusion criteria. | Other | arm (A) - stoppage of antibiotics |
| amoxycillin/clavulanic acidIn arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin) | Other | arm (B) - oral antibiotics till ANC ≥ 500 |
| levofloxacinIn arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin) | Other | arm (B) - oral antibiotics till ANC ≥ 500 |
Primary outcome
Treatment is considered to be successful if the following is attained without changing the regimen - Patient remains afebrile till recovery of ANC ≥500 •Measure of effect: Proportion of patients afebrile in each arm
Time frame: till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days
1 secondary outcome
Rate of re-admission
Time frame: till ANC ≥ 500 or reappearance of fever during the period ≤10 days
Results and safety
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameer Bakhshi, Professor study director
Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing stoppage of antibiotics, amoxycillin/clavulanic acid and levofloxacin in people with Neutropenia, Febrile and Pediatric Cancer, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment is considered to be successful if the following is attained without changing the regimen - Patient remains afebrile till recovery of ANC ≥500 •Measure of effect: Proportion of patients afebrile in each arm (time frame: till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.