Protocol summary

Summary
Streptococcus pneumoniae is the most prevalent cause of respiratory tract bacterial infection. In recent years, high resistance of pneumococ toward antibiotics strains has been reported. In this study, resistance pattern of Pneumococcal Pneumonia toward Ceftriaxone, Azithromycin and Co-amoxiclav in clinic and lab has been investigated. Method: in this study, between September 2012 and February 2014, adult patients at infectious clinic of Birjand Vali-asr hospital, who were detected having pneumonia, were studied in single blind clinical trials. Patients were randomly assigned to one of the three medicine diets of Azithromycin, Ceftriaxone and Co-amoxiclav; after 48-72 hours, patients who were detected having streptococcus pneumonia were sustained in our study and their clinic and laboratory resistance were compared using the three regimens mentioned above. Data analysis was conducted by the use of SPSS 15, Chi-square test, Fisher exact test and Kappa coefficient test.

General information

Acronym
streptococus pneumonia
IRCT registration information
IRCT registration number: IRCT2014062318206N1
Registration date: 2014-10-03, 1393/07/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-03, 1393/07/11
Registrant information
Name
Azadeh Ebrahimzadeh
Name of organization / entity
Birjand Universtiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 8671
Email address
a.ebrahimzadeh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand Universtiy of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
On the Investigation of Resistance Pattern of Pneumococcal Pneumonia toward Ceftriaxone, Azithromycin and Co-amoxiclav in Clinic and Laboratory
Public title
pneumococal pneumonia resistance to antibiotics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 15 years old and diagnosis of pneumococcus infection. Exclusion criteria: epast antibiotc in 48 hours and toxicity drug reaction.
Age
From 15 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were randomly assigned to one of the three medicine diets of Azithromycin, Ceftriaxone and Co-amoxiclav; after 48-72 hours, patients who were detected having streptococcus pneumonia were sustained in our study and their clinical and laboratory resistance were compared.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Birjand Universtiy of Medical Sciences
Street address
Birjand Universtiy of Medical Sciences, Ghaffari street
City
Birjand
Postal code
9718797187
Approval date
2012-07-22, 1391/05/01
Ethics committee reference number
91-05-04

Health conditions studied

1

Description of health condition studied
Pneumococcus pneumonia
ICD-10 code
J13
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae

Primary outcomes

1

Description
Fever
Timepoint
72 hours
Method of measurement
Thermometer

Secondary outcomes

1

Description
Drug reaction
Timepoint
48 hours
Method of measurement
Observation

Intervention groups

1

Description
Azithromycin (orally 500 mg in first day, and 250 mg for the next days) for 10 days
Category
Treatment - Drugs

2

Description
Amp Ceftriaxone (infusion 1 gram per 12 hours) for72 hours and then cap cefixime 200 mg one 12 hours for complete 10 days
Category
Treatment - Drugs

3

Description
Cap Co-amoxiclav (orally 625 mg per 8 hours) for 10 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Aasr Hospital
Full name of responsible person
Azadeh Ebrahimzadeh
Street address
Vali Asr Hospital
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research assistant office Birjand University of Medical Sciences
Full name of responsible person
Dr. Asghar Zarban
Street address
Third floor, Birjand University of Medical Sciences, Research Assistant Office
City
Birjand
Grant name
جاری
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research assistant office Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Azadeh Ebrahimzadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
9718797187
Phone
+98 56 1444 8671
Fax
Email
a.ebrahimzadeh@bums.ac.ir; mr14436@yahoo.comm.zare@live.co.uk
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Azadeh Ebrahimzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
9781797187
Phone
+98 56 1444 8671
Fax
Email
a.ebrahimzadeh@bums.ac.ir; mr14436@yahoo.comm.zare@live.co.uk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Gholam Reza Sharifzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
9718797187
Phone
+98 56 1882 5377
Fax
+98 56 1444 0388
Email
rezamood@yahoo.com; m.zare@live.co.uka; ebrahimzadeh@bums.ac.ir
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
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