Neutropenia, FebrilePhase 4NCT04187755
Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever
A Phase 4 study testing Ceftazidime Injection and Cefepime Injection in people with Neutropenia, Febrile and Leukemia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Empirical antibiotic therapy has been known to reduce the mortality and morbidity rate in neutropenic fever. Until now, ceftazidime was the first line choice of neutropenic fever. However, resistance against ceftazidime has been reported. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Neutropenia, Febrile, Leukemia, Pediatric Cancer
- What is being tested?
- Ceftazidime Injection and Cefepime Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2019to 31 Jul 2019
- Phase
- Phase 4
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with leukemia aged 1 month to 18 years old undergoing chemotherapy
- having fever of ≥ 38,3 0C in axillar temperature
- ANC < 1000/mm3
- patients' parents or guardians must be willing to participate and willing to sign a written informed consent form
Who cannot join
- patients with a history of penicillin or cephalosporin allergy
- patients with kidney dysfunction
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta
About this study
Official title: Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever in Pediatric Acute Leukemia: Review of Temperature and Absolute Neutrophil
Empirical antibiotic therapy has been known to reduce the mortality and morbidity rate in neutropenic fever. Until now, ceftazidime was the first line choice of neutropenic fever. However, resistance against ceftazidime has been reported. Several countries have reported cefepime in reducing fever and shorten the length of hospitalization better than ceftazidime. This study is aimed to compare the effectivity of ceftazidime and cefepime to reduce fever and to increase the absolute neutrophils count (ANC) in the first 72 hours.
Read the detailed description
This study is a randomized controlled trial with single blinding, conducted in the children's hematology-oncology wards of Cipto Mangunkusumo Hospital and Harapan Kita Children's Hospital in Jakarta, December 2018 through May 2019. Study population includes all children with leukemia with febrile neutropenia episodes that are being hospitalized in our hospitals in the appropriate time. Subjects were chosen by consecutive sampling. Inclusion criteria includes children with leukemia aged 1 month to 18 years old undergoing chemotherapy, having fever of ≥ 38,3 degree celsius in axillar temperature with ANC < 1000/mm3. Patients' parents or guardians must be willing to participate and willing to sign a written informed consent form. Exclusion criteria includes patients with a history of penicillin or cephalosporin allergy and/or patients with kidney dysfunction. Block randomization was done to place each patient into cefepime or ceftazidime group. Data analysis was done using SPSS ver. 21 software. Numerical data was shown as mean with standard deviation if the data is normally distributed or median with minimum-maximum value if the data is not normally distributed. Chi-square as the correlation test was done in order to determine the association between free and dependent variables, based on nominal data. Mann Whitney test was done as the correlation test in order to test the difference between medians of uncoupled groups and one categorical variable, and one interval variable and the not normally distributed data.
- Conditions
- Neutropenia, Febrile, Leukemia, Pediatric Cancer, Antibiotic Reaction
- Being tested
- Ceftazidime Injection, Cefepime Injection
- Keywords
- fever, neutropenia, temperature, absolute neutrophil count, antibiotic
- Medical subject headings
- Febrile Neutropenia, Leukemia, Neoplasms, Fever, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftazidime InjectionDrug
Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly)
Cefepime InjectionDrug
Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly)
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Participants were given ceftazidime as the antibiotic therapy with standard regimens and dose of antibiotic Receives: Drug: Ceftazidime Injection |
| Group II | Experimental | Participants were given cefepime as the antibiotic therapy with standard regimens and dose of antibiotic Receives: Drug: Cefepime Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature decrease
Decrease of temperature <= 37,5 degree celsius after administration of antibiotic
Measured: after 72 hours of antibiotic adminstration
Increase of Absolute Neutrophil Count
ANC >= 1000
Measured: after 72 hours of antibiotic administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Mar 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
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.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly divided into two intervention groups, ceftazidime and cefepime, each group consist of 36 patients. Patients were treated, the results were noted after 72 hours.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murti Andriastuti, Doctor, Universitas Indonesia
- Investigators
- Murti A MD,PhD, Study director, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187755
- Sponsor's protocol ID
- CefepimevsCeftazidime
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever in Pediatric Acute Leukemia: Review of Temperature and Absolute Neutrophil
- ClinicalTrials.gov ID
- NCT04187755
- Acronym / sponsor ID
- CefepimevsCeftazidime
- Conditions
- Neutropenia, Febrile, Leukemia, Pediatric Cancer, Antibiotic Reaction
- Keywords
- fever, neutropenia, temperature, absolute neutrophil count, antibiotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 5 Dec 2019 (actual)
- 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.
Empirical antibiotic therapy has been known to reduce the mortality and morbidity rate in neutropenic fever. Until now, ceftazidime was the first line choice of neutropenic fever. However, resistance against ceftazidime has been reported. Several countries have reported cefepime in reducing fever and shorten the length of hospitalization better than ceftazidime. This study is aimed to compare the effectivity of ceftazidime and cefepime to reduce fever and to increase the absolute neutrophils count (ANC) in the first 72 hours.
Detailed description
This study is a randomized controlled trial with single blinding, conducted in the children's hematology-oncology wards of Cipto Mangunkusumo Hospital and Harapan Kita Children's Hospital in Jakarta, December 2018 through May 2019. Study population includes all children with leukemia with febrile neutropenia episodes that are being hospitalized in our hospitals in the appropriate time. Subjects were chosen by consecutive sampling. Inclusion criteria includes children with leukemia aged 1 month to 18 years old undergoing chemotherapy, having fever of ≥ 38,3 degree celsius in axillar temperature with ANC < 1000/mm3. Patients' parents or guardians must be willing to participate and willing to sign a written informed consent form. Exclusion criteria includes patients with a history of penicillin or cephalosporin allergy and/or patients with kidney dysfunction. Block randomization was done to place each patient into cefepime or ceftazidime group. Data analysis was done using SPSS ver. 21 software. Numerical data was shown as mean with standard deviation if the data is normally distributed or median with minimum-maximum value if the data is not normally distributed. Chi-square as the correlation test was done in order to determine the association between free and dependent variables, based on nominal data. Mann Whitney test was done as the correlation test in order to test the difference between medians of uncoupled groups and one categorical variable, and one interval variable and the not normally distributed data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients were randomly divided into two intervention groups, ceftazidime and cefepime, each group consist of 36 patients. Patients were treated, the results were noted after 72 hours.
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Ceftazidime InjectionParticipants were given ceftazidime as the antibiotic therapy with standard regimens and dose of antibiotic |
| Group II | Experimental | Drug: Cefepime InjectionParticipants were given cefepime as the antibiotic therapy with standard regimens and dose of antibiotic |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- children with leukemia aged 1 month to 18 years old undergoing chemotherapy
- having fever of ≥ 38,3 0C in axillar temperature
- ANC < 1000/mm3
- patients' parents or guardians must be willing to participate and willing to sign a written informed consent form
Key exclusion criteria (2 listed)
- patients with a history of penicillin or cephalosporin allergy
- patients with kidney dysfunction
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 |
|---|---|---|
| Ceftazidime InjectionCeftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly) | Drug | Group I |
| Cefepime InjectionCefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly) | Drug | Group II |
Primary outcome
Temperature decrease
Time frame: after 72 hours of antibiotic adminstration
Decrease of temperature <= 37,5 degree celsius after administration of antibiotic
Increase of Absolute Neutrophil Count
Time frame: after 72 hours of antibiotic administration
ANC >= 1000
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Murti A MD,PhD study director
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftazidime Injection and Cefepime Injection in people with Neutropenia, Febrile and Leukemia, run by Universitas Indonesia at 1 site in Indonesia.
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 2 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: finished, as of the sponsor's last update on 6 Dec 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 Indonesia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Temperature decrease (time frame: after 72 hours of antibiotic adminstration). The study lists 2 primary outcomes in all. 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 6 Dec 2019.