The aim of this randomized single blind controlled trial is to investigate the efficacy of two drug regimens in the treatment of pneumonia. In this trial, 82 patients aged over 12 years old with pneumonia referred to Infectious clinic of Beheshti Hospital, are randomly assigned to the intervention or control groups. The patients in the first group will receive high-dose amoxicillin (1 mg TDS ) plus azithromycin 500 mg stat and 250 mg daily and in the second group will receive cefixime 400 mg daily plus azithromycin 500 mg stat and 250 mg daily. Primary outcomes are response to the treatment based on the fever, cough, and clinical symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107096922N2
Registration date:2011-08-08, 1390/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-08, 1390/05/17
Registrant information
Name
Afsaneh Karami
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 0801
Email address
rastin@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2008-02-20, 1386/12/01
Expected recruitment end date
2008-09-01, 1387/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy in therapy with cefixime plus azithromycin versus high-dose amoxicillin plus azithromycin among patients with pneumonia
Public title
Efficacy of two drug regimens in the treatment of pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: out-patients with pneumonia, age over 12 years
Exclusion criteria: inpatients with pneumonia; Failure to refer the patient
Age
From 12 years old to 82 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
N/A
Randomization description
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi St., Zanjan
City
Zanjan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1390415
Health conditions studied
1
Description of health condition studied
Efficacy of cefixime in pneumonia treatment
ICD-10 code
J15, J15.9
ICD-10 code description
Bacterial pneumonia, not elsewhere classified & Bacterial pneumonia, unspecified
Primary outcomes
1
Description
patient's general appearance
Timepoint
after 1 week and after the treatment (10th day)
Method of measurement
physical exam
2
Description
fever
Timepoint
after 1 week and after the treatment (10th day)
Method of measurement
termometer
3
Description
cough
Timepoint
after 1 week and after the treatment (10th day)
Method of measurement
patient's complaint and daily notes
4
Description
lung auscultation to normal
Timepoint
after 1 week and after the treatment (10th day)
Method of measurement
lung auscultation with stetoscope
Secondary outcomes
1
Description
shock
Timepoint
after 1 week and after the treatment (10th day)
Method of measurement
measurement of BP
2
Description
respiratory failure
Timepoint
after 1 week and after the treatment (10th day)
Method of measurement
physical exam
3
Description
level of consiousness
Timepoint
after 1 week and after the treatment (10th day)
Method of measurement
physical exam
Intervention groups
1
Description
Cefixime 400mg / day orally for 10 days + Azithromycine 500 mg stat and 250mg daily orally
Category
Treatment - Drugs
2
Description
Amoxicillin 1gr TDS for 10 days orally + Azithromycine 500 mg stat and 250mg daily orally