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Trial record 3 of 3 for:    9459469 [PUBMED-IDS]

Suitability of Antibiotic Treatment for CAP (CAPTIME)

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ClinicalTrials.gov Identifier: NCT01661920
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
ALBERTO CAPELASTEGUI SAIZ, Hospital Galdakao-Usansolo

Brief Summary:
The duration of antibiotic treatment in community-acquired pneumonia (CAP) lasts about 9-10 days, and is determined empirically. The last North American guideline for CAP recommends using clinical stability criteria as a reference to establish the duration of antibiotic treatment, which would result in about 5 days of antibiotic use for the majority of pneumonia cases. In order to validate this proposal we propose to carry out a randomized multicenter double-blind (until the 5th day) clinical trial with adult CAP patients admitted to 4 hospitals in Euskadi. A control group (with routine treatment) will be compared with an intervention group (antibiotic treatment for at least 5 days, which will be interrupted if temperature is =< 37,8ºC for at least 48 hours and no more than one sign of clinical instability is assessed), with regards to: mortality at 15 days, clinical recovery by days 10 and 30, clinical improvement after days 5 and 10 as evaluated by PRO scales, duration of antibiotic treatment. A non-inferiority dichotomous sequential analysis will be performed (for mortality after 15 days, clinical recovery by day 10 and in follow-up at 30 days, clinical improvement after days 5 and 10, with PRO scales) as well as a superiority analysis for the duration of the antibiotic treatment. A total of 1100 patients will be recruited, following their signed consent, during the inclusion period (18 months). Stability criteria will be measured daily. The rest of the variables will be measured at admission and by telephone on days 10 and 30.

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Other: Intervention group Other: Control group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. duration of the antibiotic treatment [ Time Frame: 30 days ]
    days taht the patient takes an antibiotic treatment, adding intravenous and oral

  2. mortality [ Time Frame: 15 days ]
    the mortality in fifteen days

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 1- In-hospital mortality for any cause [ Time Frame: 30 days ]
    Mortality within 30 days after admission, whether related or unrelated to pneumonia.

  2. Readmission [ Time Frame: 30 days ]
    Readmission within 30 days after admission for reasons related or unrelated to pneumonia.

  3. 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.

  4. 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.

  5. Duration of hospital stay [ Time Frame: 30 days ]
    days the patient needs to be hospitalized for pneumonia

  6. days to return to normal activity [ Time Frame: 30 days ]
    days the patient needs to carry out their daily lives



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 or older,
  • admitted with CAP will be included sequentially. Pneumonia is defined as pulmonary infiltrate shown in a thoracic X-ray not known to be old,

Exclusion Criteria:

  • patients with human immunodeficiency virus infection,
  • immunosupressed patients (with a solid organ transplant, spelenectomy, treated with a prednisone dose of 10 mg/day or equivalent for longer than 30 days or with other immunodepressors, with neutropenia),
  • those hospitalized in the 14 days prior and those living in assisted care facilities.
  • pneumonia cases caused by infrequent agents (i.e. P. aerouginosa, S. Aureus) will also be excluded, as well as infectious processes requiring an extended treatment with antibiotocs (i.e. bacterial endocarditis, abscesses),
  • pneumonia cases with pleural effusion requiring a drainage tube,
  • patients who were deceased or admitted to ICU before randomization and those not giving their informed consent.

Information from the National Library of Medicine

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


Locations
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Spain
Hospital Txagorritxu
Vitoria, Alava, Spain, 01009
Hospital San Eloy
Barakaldo, Bizkaia, Spain, 48902
Hospital Basurto
Bilbao, Bizkaia, Spain, 48013
Hospital Galdakao
Galdakao, Bizkaia, Spain, 48960
Sponsors and Collaborators
Hospital Galdakao-Usansolo
Investigators
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Principal Investigator: ALBERTO CAPELASTEGUI, PhD, MD Osakidetza

Publications of Results:

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Responsible Party: ALBERTO CAPELASTEGUI SAIZ, Head of Pneumology Service of Galdakao Hospital. PhD, MD., Hospital Galdakao-Usansolo
ClinicalTrials.gov Identifier: NCT01661920     History of Changes
Other Study ID Numbers: CAPTIME
2011-001067-51 ( EudraCT Number )
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015
Keywords provided by ALBERTO CAPELASTEGUI SAIZ, Hospital Galdakao-Usansolo:
Community Acquired Pneumonia.
Treatment duration
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents