This is a clinical trial study that will be performed to compare imipenem with ceftazidim/amikacin for empirical treatment of cancer patients with febrile neutropenia. Also compare type of dominant germ and antibiotic resistance in different cultures in these patients. Inclusion criteria: patients aged more than 18 years with cancer; recent chemotherapy; oral temperature more than 38.3˚c or more than 38 ˚c for 1 hour; neutrophil lower than 1500/micro liter. Exclusion criteria: pregnancy and breast feeding; use of antibiotic for at least 3 days before randomization; CNS infection; blastic crisis; coma; septic shock; definite origin for fever. In this study, target population is Cancer patients that are more than 18 years with fever and neutropenia. In each group, there are 61 persons. In this study, the patients will be randomly divided to two group that consist of 61 people; one group is under intravenous infusion of imipenem 500 milligram every 6 hour and second group is under intravenous infusion of ceftazidim 2 gram every 8 hour and amikacin 15 milligram/kilogram/day . Temperature evaluate in both group with mercury thermometer, daily. Duration of treatment in both groups is 3 days. We hope fever stop after 3 days and blood cultures were negative.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121511756N1
Registration date:2013-05-26, 1392/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-26, 1392/03/05
Registrant information
Name
Zahra Zamani
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3630
Email address
dr.zamani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
combination therapy with ceftazidim and amikacin versus Imipenem monotherapy for empirical treatment of febrile neutropenic cancer patients.
Public title
combination therapy with ceftazidim and amikacin versus Imipenem monotherapy for empirical treatment of febrile neutropenic cancer patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged more than 18 years with cancer; recent chemotherapy; oral temperature more than 38.3˚c or more than 38 ˚c for 1 hour and neutrophil lower than 1500/micro liter.
Exclusion criteria: pregnancy and breast feeding; use of antibiotic for at least 3 days before randomization; CNS infection; blastic crisis;coma; septic shock and definite origin for fever.
Age
From 18 years old to 95 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences Ethics Committee
Street address
Sardasht- Arak University of Medical Sciences
City
Arak
Postal code
38481-7-6941
Approval date
2012-08-12, 1391/05/22
Ethics committee reference number
809
Health conditions studied
1
Description of health condition studied
Neutropenia
ICD-10 code
D70
ICD-10 code description
Agranulocytosis
Primary outcomes
1
Description
fever
Timepoint
daily for 3 days
Method of measurement
centigrade-termometer
2
Description
culture
Timepoint
day 1-day 3
Method of measurement
colony/mm3-culture medium
Secondary outcomes
1
Description
convulsion
Timepoint
daily during treatment period
Method of measurement
history
2
Description
renal failure
Timepoint
daily during treatment period
Method of measurement
milligram/deciliter-creatinin measurement
Intervention groups
1
Description
Ceftazidim 500 milligram intravenous every 6 hours and Amikacine 15 milligram/kilogram/day intravenous for 3 days
Category
Treatment - Drugs
2
Description
Imipenem 500 milligram intravenous every 6 hours for 3 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khansari hospital
Full name of responsible person
Zahra zamani- Physician- Internist resident
Street address
University street- Ghanat naseri
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Saied Ashtiani
Street address
Sardasht- Arak University of Medical Sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Zamani
Position
MD, Internist resident
Other areas of specialty/work
Street address
Sardasht- Arak University of Medical Sciences
City
Arak
Postal code
38481-76941
Phone
+98 86 1417 3502
Fax
+98 86 1417 3521
Email
daneshkadeha@arakmu.ac.ir
Web page address
www.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anooshiravani
Position
Internist-hematologist
Other areas of specialty/work
Street address
Sardasht, Arak University of Medical Sciences
City
Arak
Postal code
38481-76941
Phone
+98 86 1417 3502
Fax
+98 41 73521
Email
daneshkadeha@arakmu.ac.ir
Web page address
www.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Zamani
Position
MD, Internist resident
Other areas of specialty/work
Street address
Sardasht- Arak University of Medical Sciences
City
Arak
Postal code
38481-76941
Phone
+98 86 1417 3502
Fax
+98 86 1417 3521
Email
daneshkadeha@arakmu.ac.ir
Web page address
www.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)