FebrileNCT01714570
Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia
A study testing Piperacillin-tazobactam combination product and Imipenem in people with Febrile and Neutropenia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as first-line mono-therapy for febrile patients with neutropenia of high risk. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Febrile, Neutropenia, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Piperacillin-tazobactam combination product and Imipenem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Apr 2014
- Phase
- Interventional
- 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 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 13-65 years
- received Autologous or Allogeneic hematopoietic stem cell transplantation.
- ECOG score 0-1.
- ICF is available.
Who cannot join
- Allergic to any therapy drug.
- Documented infection before neutropenia.
- Renal dysfunction.
- Suffering from central nervous system or mental disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Open Label Study of Piperacillin/Tazobactam Versus Imipenem/Cilastin for Empirical Therapy of Febrile Patients With Neutropenia After Hematopoietic Stem Cell Transplantation
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell transplantation is very limited.
The current study will evaluate the efficacy of piperacillin/tazobactam compared with imipenem/cilastatin for febrile neutropenia after transplantation.
Read the detailed description
- Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
- Randomize the febrile patients into 2 groups.
- Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.
- Being tested
- Piperacillin-tazobactam combination product, Imipenem
- Medical subject headings
- Fever, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin-tazobactam combination productDrug
Also called Tazocin
4.5g q6h, 5-10 days
ImipenemDrug
Also called Tienam
0.5g q6h, 5-10 days
| Study group | Role | What they receive |
|---|---|---|
| piperacillin/tazobactam | Experimental | Not described Receives: Drug: Piperacillin-tazobactam combination product |
| imipenem/cilastatin | Active comparator | Not described Receives: Drug: Imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate.
Resolve of clinical symptoms and signs, without change of therapy.
Measured: 3 weeks after beginning of empirical therapy
Secondary outcomes (3)
Microbiologic success rate
Microbiologic success includes eradication, suspected eradication, and super-infection.
- Eradication or Presumed eradication: the baseline pathogens no longer present on the culture performed after completion of treatment. If no way to collect biologic sample(s) after treatment;, e.g. sputum, a presumed eradication will be concluded
- No eradication: one or more baseline pathogens were persistent
- Relapse: the baseline pathogens transient absence reappeared during the therapy
- Alternative: the baseline pathogens were eradicated, but new ones appeared without any clinical signs and symptoms
- Re-infection: the baseline pathogens were eradicated, but new ones appeared with clinical signs and symptoms.
Measured: 3 weeks after beginning of empirical therapy
Adverse effect
The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy.
Measured: 3 weeks after beginning of empirical therapy
Cost of drug and therapy
Measured: 3 weeks after beginning of empirical therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FebrileStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenrong Huang, Chinese PLA General Hospital
- Investigators
- wenrong huang, Doctor, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714570
- Sponsor's protocol ID
- PTZ-20120702
- Status last verified
- Apr 2014
- First submitted
- 4 Jul 2012
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Label Study of Piperacillin/Tazobactam Versus Imipenem/Cilastin for Empirical Therapy of Febrile Patients With Neutropenia After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01714570
- Acronym / sponsor ID
- PTZ-20120702
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Oct 2012 (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.
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell transplantation is very limited.
The current study will evaluate the efficacy of piperacillin/tazobactam compared with imipenem/cilastatin for febrile neutropenia after transplantation.
Detailed description
- Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
- Randomize the febrile patients into 2 groups.
- Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| piperacillin/tazobactam | Experimental | Drug: Piperacillin-tazobactam combination product |
| imipenem/cilastatin | Active comparator | Drug: Imipenem |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 13-65 years
- received Autologous or Allogeneic hematopoietic stem cell transplantation.
- ECOG score 0-1.
- ICF is available.
Key exclusion criteria (4 listed)
- Allergic to any therapy drug.
- Documented infection before neutropenia.
- Renal dysfunction.
- Suffering from central nervous system or mental disease.
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 |
|---|---|---|
| Piperacillin-tazobactam combination productAlso: Tazocin4.5g q6h, 5-10 days | Drug | piperacillin/tazobactam |
| ImipenemAlso: Tienam0.5g q6h, 5-10 days | Drug | imipenem/cilastatin |
Primary outcome
Clinical success rate.
Time frame: 3 weeks after beginning of empirical therapy
Resolve of clinical symptoms and signs, without change of therapy.
3 secondary outcomes
Microbiologic success rate
Time frame: 3 weeks after beginning of empirical therapy
Adverse effect
Time frame: 3 weeks after beginning of empirical therapy
Cost of drug and therapy
Time frame: 3 weeks after beginning of empirical therapy
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 17 Apr 2014.
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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.
wenrong huang, Doctor principal investigator
Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piperacillin-tazobactam combination product and Imipenem in people with Febrile and Neutropenia, run by Chinese PLA General Hospital at 1 site in China.
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 4 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 17 Apr 2014. 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 China. 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.
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?
Clinical success rate. (time frame: 3 weeks after beginning of empirical therapy). 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 17 Apr 2014.