Suitability of Antibiotic Treatment for CAP (CAPTIME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01661920|
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : August 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Community Acquired Pneumonia||Other: Intervention group Other: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||602 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Suitability of Antibiotic Treatment for Community-acquired Pneumonia|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||April 2014|
Experimental: INTERVENTION GROUP
Patients with diagnosis of CAP with shorten treatment, defined as 5 days antibiotic treatment.
Other: Intervention group
Shorten the duration of antibiotic treatment from 7-10 days to 5 days.
Active Comparator: CONTROL GROUP
Patients with diagnosis of CAP which antibiotic treatment duration will be not modified by their doctors.
Other: Control group
Those antibiotic duration treatments which are not modified by their doctors.
- duration of the antibiotic treatment [ Time Frame: 30 days ]days taht the patient takes an antibiotic treatment, adding intravenous and oral
- mortality [ Time Frame: 15 days ]the mortality in fifteen days
- clinical cure [ Time Frame: 10 days ]resolution or improvement of symptoms and clinical signs related to pneumonia without a need for additional or alternative antibiotic treatment.
- clinical cure [ Time Frame: 30 days ]resolution or improvement of symptoms and clinical signs related to pneumonia without a need for additional or alternative antibiotic treatment.
- 1- In-hospital mortality for any cause [ Time Frame: 30 days ]Mortality within 30 days after admission, whether related or unrelated to pneumonia.
- Readmission [ Time Frame: 30 days ]Readmission within 30 days after admission for reasons related or unrelated to pneumonia.
- Days needed to reach clinical stability [ Time Frame: 30 days ]Days off work due to disease. Days with restricted regular activity (work or recreation) due to pneumonia. Days with adverse effects due to medication.
- Recurrence [ Time Frame: 30 days ]new (or worsening) symptoms and signs related to pneumonia and with a new infection of the respiratory tract in a patient considered cured on the 10th day visit.
- Duration of hospital stay [ Time Frame: 30 days ]days the patient needs to be hospitalized for pneumonia
- days to return to normal activity [ Time Frame: 30 days ]days the patient needs to carry out their daily lives
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661920
|Vitoria, Alava, Spain, 01009|
|Hospital San Eloy|
|Barakaldo, Bizkaia, Spain, 48902|
|Bilbao, Bizkaia, Spain, 48013|
|Galdakao, Bizkaia, Spain, 48960|
|Principal Investigator:||ALBERTO CAPELASTEGUI, PhD, MD||Osakidetza|