Protocol summary

Summary
the purpose of this triple blind clinical trial is to compare between cefixime and co-amoxiclave therapeutic effects in outpatient treatment of acute community acquired pneumonia. in this study 310 CAP patients treated in Arak University clinics are going to divide into 2 groups(co-amoxiclave 625mg/tds and cefixime 400mg/day for 2 weeks) randomly. therapeutic effects of the drugs will be evaluate in 2th and 4th week after treatment and will be compare to first visit evaluation between both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111186056N4
Registration date: 2011-11-21, 1390/08/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-11-21, 1390/08/30
Registrant information
Name
Nader Zarinfar
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1224 1411
Email address
zarinfar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2007-06-22, 1386/04/01
Expected recruitment end date
2008-08-20, 1387/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between cefixime and co-amoxiclave therapeutic effects in outpatient treatment of acute community acquired pneumonia
Public title
Comparison between cefixime and co-amoxiclave therapeutic effects in outpatient treatment of acute community acquired pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of acute community acquired pneumonia; age more than15 years and capable of giving informed consent. Exclusion criteria: immune deficiency disease or corticosteroids medication; allergy to beta-lactam drugs and weight less than 35 kg
Age
From 15 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 310
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Arak university of medical sciences
Street address
Arak University of Medical Sciences, Alamalhoda st.
City
Arak
Postal code
Approval date
2007-05-23, 1386/03/02
Ethics committee reference number
89-83-7/1

Health conditions studied

1

Description of health condition studied
Pneumonia
ICD-10 code
J14
ICD-10 code description
Pneumonia due to Haemophilus influenzae

Primary outcomes

1

Description
Therapeutic effects
Timepoint
At the begining, 2th and 4th weeks
Method of measurement
Clinical examination and chest X ray

Secondary outcomes

1

Description
Pulmonary abscess
Timepoint
Second and 4th weeks
Method of measurement
Clinical examination and chest X ray

2

Description
pulmonary empyema
Timepoint
2TH,4TH WEEKS
Method of measurement
clinical examination and CXR

3

Description
Pleural effusion
Timepoint
Second and 4th weeks
Method of measurement
Clinical examination and chest X ray

Intervention groups

1

Description
Intervention group: Cefixime 400mg/day + 2 placebo capsuls for 2 weeks
Category
Treatment - Drugs

2

Description
Control group: Co-amoxiclave 625mg/tds for 2 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital clinic
Full name of responsible person
Street address
City
Arak

2

Recruitment center
Name of recruitment center
Alavi clinic
Full name of responsible person
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Arak University of Medical Sciences
Full name of responsible person
Dr.Saeed Changizi Ashtiyani
Street address
Arak University of Medical Sciences, Sardasht st.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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
Dr. Nader Zarinfar
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Valiasr hospital
City
Arak
Postal code
Phone
+98 86 1223 5605
Fax
Email
zarinfar@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Nader Zarinfar
Position
Infectiouse disease specialist
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Valiasr hospital
City
Arak
Postal code
Phone
+98 86 1223 5605
Fax
Email
zarinfar@arakmu.ac.ir; daesmaili@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Akram Esmaili
Position
MD
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
Phone
Fax
Email
daesmaili@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...