Our objective was to assess the efficacy of oral ciprofloxacin in preventing fever and infection among neutropenic patients. In this unicenter double blinded phase 2 randomized controlled clinical trial, we enrolled male and female patients aged 17 to 80 with solid or hematologic neutropenia who were diagnosed neutropenic following chemotherapy without fever and any history of recent antibiotic usage. 120 neutropenic patients after confirming not to have fever or consumption of antibiotics in last 7 days were randomized into two 60 person groups. The first group received oral ciprofloxacin, 500 mg/bid and the second group received similar placebo. The interventions were continued until occurrence of fever or resolution of neutropenic in non-febrile patients. The main outcome was fever occurrence and secondary outcomes were occurrence of bacterial infection and death.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092924266N1
Registration date:2016-02-11, 1394/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-11, 1394/11/22
Registrant information
Name
Reza Ghalehtaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2520
Email address
r-ghaletaki@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
AJA University, Committee of Research
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2015-06-30, 1394/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of ciprofloxacin in preventing infection among patients with chemotherapy induced neutropenia in a university medical center in Iran
Public title
The efficacy of ciprofloxacin in preventing infection among patients with chemotherapy induced neutropenia in a university medical center in Iran
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Absolute neutrophil count < 500 or less 1000 with predicted fall to below 500 in 48-72 hours; History of Malignancy.
Exclusion criteria: Fever or Any sign of clinical or microbiological infection; Any history of antibiotic consumption lately before admission.
Age
From 17 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the AJA University of Medical Sciences
Street address
ٍEthics committee of the AJA University of Medical Sciences, Etemadian Avenue, Fatemi Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-07-10, 1392/04/19
Ethics committee reference number
9206
Health conditions studied
1
Description of health condition studied
Neutropenia
ICD-10 code
D70
ICD-10 code description
Agranulocytosis
2
Description of health condition studied
Fever
ICD-10 code
R50.9
ICD-10 code description
Fever, unspecified
Primary outcomes
1
Description
Fever
Timepoint
After intervention
Method of measurement
Body core temperature by Thermometer
Secondary outcomes
1
Description
Bacterial Infection
Timepoint
After intervention
Method of measurement
Blood, urine or sputum culture
Intervention groups
1
Description
Intervention:
Administration of Oral tablets of Ciprofloxacin 500 mg/bid after diagnosis of neutropenia until occurrence of fever or resolution of neutropenia
Category
Prevention
2
Description
Control: Administration of Oral tablets of Placebo /bid after diagnosis of neutropenia until occurrence of fever or resolution of neutropenia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (501) Hospital of IRI army
Full name of responsible person
Ali Asgari
Street address
Imam Reza (501) Hospital of IRI army, Etemadian Avenue, Fatemi Street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Dr Banafsheh Dormansesh, Deputy of Research, AJA University of Medical Sciences
Street address
AJA University of Medical Sciences, Etemadian ave., Fatemi Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA 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
Infectious Diseases Research Center, AJA University of Medical Sciences
Full name of responsible person
Ali Asgari
Position
Faculty/Assistant professor/MD
Other areas of specialty/work
Street address
AJA University of Medical Sciences, Etemadian Avenue, Fatemi Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8454 9913
Fax
Email
aliasgari222@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infectious Diseases Research Center, AJA university of medical sciences
Full name of responsible person
Ali Asgari
Position
Faculty/ MD
Other areas of specialty/work
Street address
AJA University of Medical Sciences, Etemadian Avenue, Fatemi Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8454 9913
Fax
Email
aliasgari222@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Ali Asgari
Position
Faculty/ Assistant Professor
Other areas of specialty/work
Street address
AJA University of Medical Sciences, Etemadian Avenue, Fatemi Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8454 9913
Fax
Email
aliasgari222@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)