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Clinical trial for evaluation of effect of procalcitonin-based algorithm in duration of antibiotic therapy and hospitalization of community acquired pneumonia and chronic obstructive pulmonary disease exacerbation

Protocol summary

Summary
The use of biomarkers in diagnostic and therapeutic approach to community acquired pneumonia ( CAP ) has been attended. The aim of this study is that whether using the procalcitonin ( PCT ) algorithm can reduce treatment duration and hospitalization in CAP without change in clinical outcomes or not. This reduction results in decrease of hospital and patient cost and antibiotic resistance. In this double blind randomized clinical trial study, 140 hospitalized patients in Infectious ward of Arak Valiasr hospital with diagnosis of pneumonia are enrolled to the study and randomly divided into two groups, case ( PCT-guided therapy ) and control group ( common treatment ). Major inclusion criteria are: diagnosis of community acquired pneumonia or chronic obstructive pulmonary disease exacerbation with at least one respiratory symptom, in addition to at least one respiratory sign on auscultation or one infection indicator. Major exclusion criteria are: Patients that can not consent voluntary, active IV drug users, severe immunosuppression, severe comorbidity, patients with hospital- acquired pneumonia and patients requiring antibiotic therapy for chronic infection. All patients would have 14 days follow up. Patient characteristics such as sex, age, place of residence, cigarette smoking, comorbidities and primary symptoms are recorded. Moreover clinical signs, radiologic and laboratory evaluation are performed and recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010331737N1
Registration date: 2017-02-24, 1395/12/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-24, 1395/12/06
Registrant information
Name
Naghmeh Arkan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
n.arkan@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-05-12, 1394/02/22
Expected recruitment end date
2016-02-11, 1394/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial for evaluation of effect of procalcitonin-based algorithm in duration of antibiotic therapy and hospitalization of community acquired pneumonia and chronic obstructive pulmonary disease exacerbation
Public title
Use of Procalcitonin in therapy of Pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients to be at least 18 years; with diagnosis of Community Acquired Pneumonia ( CAP ) or Chronic Obstructive Pulmonary Disease ( COPD ) exacerbation; with at least one respiratory symptom ( cough, sputum, dyspnea, tachypnea, pleuretic chest pain ); in addition to at least one respiratory sign on auscultation (rales,cripitation); or one infection indicator ( T greater than 38 c, chills, WBC less than 4000 or greater than 10000 per milliliter ); hospitalized in Infectious ward of Arak Valiasr University Hospital. Exclusion criteria: Patients that can't consent voluntary; active IV drug users; severe immunosuppression ( except use of corticosteroid ); severe comorbidity; patients with hospital- acquired pneumonia ( pneumonia presented at 48 hours after hospitalization or previous history of hospitalization during 14 days before this admission ); patients requiring antibiotic therapy for chronic infection.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Postal code
3819693345
Approval date
2015-05-11, 1394/02/21
Ethics committee reference number
ir.arakmu.rec.1394.23

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with acute exacerbation, unspecified

2

Description of health condition studied
Pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified

Primary outcomes

1

Description
Duration of hospitalization
Timepoint
14 days after intervention
Method of measurement
day

2

Description
Duration of treatment
Timepoint
14 days after intervention
Method of measurement
day

Secondary outcomes

1

Description
Clinical Results
Timepoint
3, 5, 7, 14 days after intervention
Method of measurement
Clinical assessment

Intervention groups

1

Description
In the case group, the antibiotic therapy is guided by serum procalcitonin. In this group, the patients are classified into four groups, according to the procalcitonin algorithm that is validated in previous studies. A procalcitonin level of less than 0.1g/L suggested the absence of bacterial infection and the initiation or continuation of antibiotics is strongly discouraged. A procalcitonin level between 0.1 and 0.25 g/L indicated that bacterial infection is unlikely, and the initiation or continuation of antibiotics is discouraged. A procalcitonin level from 0.25 to 0.5 g/L is considered to indicate a possible bacterial infection and the initiation or continuation of antibiotic therapy is encouraged. A procalcitonin level greater than 0.5 g/L strongly suggested the presence of bacterial infection and antibiotic treatment and continuation is strongly encouraged. Reassessment of procalcitonin is done in procalcitonin group at 3, 5, and 7 days if antibiotic therapy initiated and antibiotics are discontinued on the cutoffs defined above.
Category
Treatment - Other

2

Description
In the control group, the antibiotic therapy is chosen on the basis of usual practice guidelines.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr educational and therapeutic hospital of Arak
Full name of responsible person
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Anesthesiology Department, Valiasr Hospital, Valiasr Square, Arak
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
School of Medicine, Arak University of Medical Sciences
Full name of responsible person
Naghmeh Arkan
Position
PhD Student of Infectious Diseases
Other areas of specialty/work
Street address
Infectious Disease Department, Valiasr Hospital, Valiasr Square, Arak
City
Arak
Postal code
Phone
+98 86 3224 1411
Fax
Email
n.arkan@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Medicine, Arak University of Medical Sciences
Full name of responsible person
Naghmeh Arkan
Position
PhD Student of Infectious Diseases
Other areas of specialty/work
Street address
Infectious Diseases Departmnet, Valiasr Hospital, Valiasr Square, Arak
City
Arak
Postal code
Phone
+98 86 3224 1411
Fax
Email
n.arkan@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Medicine, Arak University of Medical Sciences
Full name of responsible person
Naghmeh Arkan
Position
PhD Student of Infectious Diseases
Other areas of specialty/work
Street address
Infectious Diseases Departmnet, Valiasr Hospital, Valiasr Square, Valiasr Square, Arak
City
Arak
Postal code
Phone
+98 86 3224 1411
Fax
Email
n.arkan@arakmu.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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