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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01714570
Other study ID # PTZ-20120702
Secondary ID
Status Completed
Phase N/A
First received July 4, 2012
Last updated April 16, 2014
Start date November 2012
Est. completion date April 2014

Study information

Verified date April 2014
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical 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. 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.


Description:

1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.

2. Randomize the febrile patients into 2 groups.

3. Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date April 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 65 Years
Eligibility Inclusion Criteria:

- Age 13-65 years

- received Autologous or Allogeneic hematopoietic stem cell transplantation.

- ECOG score 0-1.

- ICF is available.

Exclusion Criteria:

- Allergic to any therapy drug.

- Documented infection before neutropenia.

- Renal dysfunction.

- Suffering from central nervous system or mental disease.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Piperacillin-tazobactam combination product
4.5g q6h, 5-10 days
Imipenem
0.5g q6h, 5-10 days

Locations

Country Name City State
China Chinese PLA general hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical success rate. Resolve of clinical symptoms and signs, without change of therapy. 3 weeks after beginning of empirical therapy No
Secondary 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.
3 weeks after beginning of empirical therapy No
Secondary Adverse effect The number of patients developed unexpected medical information at the 3 weeks after beginning of empirical therapy. 3 weeks after beginning of empirical therapy Yes
Secondary Cost of drug and therapy 3 weeks after beginning of empirical therapy No
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