NeutropeniaNCT01714557
Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
A study testing Piperacillin and Piperacillin-tazobactam combination product in people with Neutropenia and Hematopoietic Stem Cell Transplantation, 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. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Neutropenia, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Piperacillin and Piperacillin-tazobactam combination product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Nov 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.
China1 site
Chinese PLA general hospital
Beijing, Beijing Municipality
Wenrong Huang, Doctor, huangwr301@yahoo.com.cn
About this study
Official title: Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia patients of high risks, while in China, major pathogens possess high resistance to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate prophylaxis regimen.
The current study will evaluate the three different regimen:
- No prophylaxic antibiotic
- Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.
- Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.
Read the detailed description
- Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
- Randomize the neutropenia patients into 3 groups.
- Receive 3 regimen.
- Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.
- For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.
- Being tested
- Piperacillin, Piperacillin-tazobactam combination product
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiperacillinDrug
4.0g q8h 3-5 days
Piperacillin-tazobactam combination productDrug
Also called Tazocin
4.5g q8h 3-5 days
| Study group | Role | What they receive |
|---|---|---|
| No prophylaxis | No intervention | Not described |
| piperacillin | Active comparator | Not described Receives: Drug: Piperacillin |
| piperacillin/tazobactam | Experimental | Not described Receives: Drug: Piperacillin-tazobactam combination product |
What is being measured
The primary outcome is the main question the study is designed to answer.
febrile rate
In both group, how many patients developed febrile.
Measured: 3 weeks after beginning of prophylaxis
Secondary outcomes (4)
Microbiologic efficacy in febrile patients
The success rate and failure rate will be calculated.
- The microbiologic culture is positive at 3 weeks of prophylaxis, showing pathogen sensitive to Piperacillin/tazobactam, the case will be evaluated as breakthrough infection, that means microbiologic failure.
- The microbiologic culture is negative at 3 weeks of prophylaxis,, or positive fungus or non-typical organisms, the case will be evaluated as microbiologic success.
Measured: 3 weeks after beginning of prophylaxis
Recovery rate from neutropenia
How many patients reached the ANC > 0.5×109/L more than 3 days.
Measured: 3 weeks after beginning of prophylaxis
AE
How many patients developed unexpected medical events.
Measured: 3 weeks after beginning of prophylaxis
Cost of drug and hospital-stay
Measured: 3 weeks after beginning of prophylaxis
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 startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
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
- NCT01714557
- Sponsor's protocol ID
- TZP-HEM-20120608
- Status last verified
- Oct 2012
- First submitted
- 4 Jul 2012
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piperacillin/Tazobactam for Prophylaxis in Patients of Neutropenia After Hematopoietic Stem Cell Transplantation - A Pilot Study
- ClinicalTrials.gov ID
- NCT01714557
- Acronym / sponsor ID
- TZP-HEM-20120608
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- 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. Almost all neutropenia will suffer from febrile without prophylactic antibiotics. IDSA recommended fluoroquinolones as prophylaxis in neutropenia patients of high risks, while in China, major pathogens possess high resistance to fluoroquinolones. It is not clear whether prophylaxis is of benefit, nor the appropriate prophylaxis regimen.
The current study will evaluate the three different regimen:
- No prophylaxic antibiotic
- Piperacillin as prophylaxis for neutropenia patients. Piperacillin has anti-pseudomonas activity.
- Piperacillin/tazobactam as prophylaxis for neutropenia patients. Piperacillin/tazobactam has highest susceptibility rate among common anti-pseudomonas antibiotics.
Detailed description
- Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
- Randomize the neutropenia patients into 3 groups.
- Receive 3 regimen.
- Full record of clinical data, including background diseases, previous antibiotics within 90 days, febrile or not at the TOC.
- For patients developed febrile, imipenem will be prescribed, even if the patient received no prophylaxis. At the same time, the follow-up ended.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No prophylaxis | No intervention | – |
| piperacillin | Active comparator | Drug: Piperacillin |
| piperacillin/tazobactam | Experimental | Drug: Piperacillin-tazobactam combination product |
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 |
|---|---|---|
| Piperacillin4.0g q8h 3-5 days | Drug | piperacillin |
| Piperacillin-tazobactam combination productAlso: Tazocin4.5g q8h 3-5 days | Drug | piperacillin/tazobactam |
Primary outcome
febrile rate
Time frame: 3 weeks after beginning of prophylaxis
In both group, how many patients developed febrile.
4 secondary outcomes
Microbiologic efficacy in febrile patients
Time frame: 3 weeks after beginning of prophylaxis
Recovery rate from neutropenia
Time frame: 3 weeks after beginning of prophylaxis
AE
Time frame: 3 weeks after beginning of prophylaxis
Cost of drug and hospital-stay
Time frame: 3 weeks after beginning of prophylaxis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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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 and Piperacillin-tazobactam combination product in people with Neutropenia and Hematopoietic Stem Cell Transplantation, 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: status not confirmed, as of the sponsor's last update on 26 Oct 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
febrile rate (time frame: 3 weeks after beginning of prophylaxis). 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 26 Oct 2012.