Investigation and comparison of the effect of changing the drug regimen containing carbapenem to piperacillin/tazobactam in the treatment of hospitalized cancer patients with fever and neutropenia
Investigation and comparison of changing drug regimen containing carbapenem to piperacillin/tazobactam in treatment
Cancer patients with fever and neutropenia
Design
Clinical trial with two study arms, with parallel groups, randomized without blinding
Settings and conduct
In this randomized clinical trial, cancer patients admitted to the oncology department of Taleghani Hospital affiliated to Shahid Beheshti University of Medical Sciences who have fever and neutropenia will be included in the study. In this study, 60 patients with fever and neutropenia will be randomly selected. They will be studied in two groups of 30 people (one group receiving carbapenem and one group receiving piperacillin/tazobactam). The patients of each group will receive the medicine from day +1 until the day when the symptoms of fever and neutropenia disappear.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Cancer patients with fever (above 38.3 degree) and neutropenia(absolute netrophil count below 500 per microliter)
Age above 18 years
exclusion criteria:
Pregnancy
Unwillingness to participate in the study
Patients with central vein catheter
Prophylactic antibiotic use before starting the study
Intervention groups
Intervention group 1: Patients receiving carbapenem
Intervention group 2: Patients receiving piperacillin/tazobactam
Main outcome variables
Confirmed infection Fever detection; Neutrophil count less than 500 per milliliter; Fever above 38.3 degrees Celsius
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N27
Registration date:2023-06-27, 1402/04/06
Registration timing:prospective
Last update:2023-06-27, 1402/04/06
Update count:0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of the effect of changing the drug regimen containing carbapenem to piperacillin/tazobactam in the treatment of hospitalized cancer patients with fever and neutropenia
Public title
Comparison the effectiveness of carbapenems and piperacillin/tazobactam in treatment of hospitalized cancer patients with fever and neutropenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18
Cancer patients with fever (above 38.3 degree) and neutropenia(absolute neutrophil count below 500 per microliter)
Hospitalized patients
Exclusion criteria:
Pregnancy
Unwillingness to participate in the study
Patients with central vein catheter
Prophylactic antibiotic use before starting the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with the help of permuted block randomization method and using online statistical randomization software, the patients of each group are divided into 2 blocks of 15 people based on the type of disease (malignancy) and age. The allocation and distribution of blocks is done with the help of software, and a code created with the help of the software is assigned to each sample.
Blinding (investigator's opinion)
Single blinded
Blinding description
-
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Behesti University of Medical Sciences
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Science, Valiasr St., Hashemi Rafsanjani Highway intersection., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2022-08-10, 1401/05/19
Ethics committee reference number
IR.SBMU.Pharmacy.REC.1401.094
Health conditions studied
1
Description of health condition studied
ّFever and neutropenia in cancer patients
ICD-10 code
D70
ICD-10 code description
Neutropenia
Primary outcomes
1
Description
Fever above 38.3 degrees Celsius
Timepoint
Every 6 hours a day
Method of measurement
Via mercury thermometer
2
Description
Neutrophil count less than 500 per milliliter
Timepoint
Every 24 hours
Method of measurement
1.Clinical signs and symptoms; 2.Laboratory data
Secondary outcomes
1
Description
Hospital length of stay
Timepoint
Daily
Method of measurement
Recording number of hospitalized days
2
Description
Duration of neutropenic status
Timepoint
Daily
Method of measurement
Blood Neutrophil count
3
Description
Need for other antibiotic consuption
Timepoint
Daily
Method of measurement
Patient's medication list
Intervention groups
1
Description
The first intervention group: receiving imipenem at a dose of 500 mg every 6 hours or meropenem 1000 mg every 8 hours in the form of an injection vial until the patient's fever resolves and the patient's neutrophil count increases to more than 500 per ml. .
Category
Treatment - Drugs
2
Description
Intervention group: receiving piperacillin/tazobactam at a dose of 4.5 grams every 8 hours (according to the dose of piperacillin) in the form of an injection vial and evaluating the patients after 72 and 96 hours after the start of antibiotic use.
Category
Treatment - Drugs
3
Description
Intervention group: If there is no improvement and no reduction in fever in patients after 72 hours of starting piperacillin/tazobactam and observing evidence of gram-positive bacteria, we prescribe vancomycin at a dose of 1 gram every 12 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Maria Tavakoli -Ardakani
Street address
Tehran, Shahid Chamran Highway, Yemen St., Shahid Arabi St.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Therapeutic findings of the intervention can be shared by statistical analysis without providing patient names.
When the data will become available and for how long
6 month after publishing the results, primary outcome data will be released.
To whom data/document is available
Doctors and other researchers in the field of infection and neutropenic fever
Under which criteria data/document could be used
People such as hospital staff or other medical staff such as nurses and clinical pharmacists can use this information.
From where data/document is obtainable
Researchers can contact the following email to receive information:
mariatavakoli@yahoo.com
What processes are involved for a request to access data/document
People who intend to use the information must be affiliated with reliable organizations and their requests should be submitted through these organizations. In this context, there is a need for an introduction letter from the desired center.