Suitability of Antibiotic Treatment for CAP

NCT01661920 | Completed

• 2 other identifiers: CAPTIME2011-001067-51
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 4

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.

Conditions

Community Acquired Pneumonia

Keywords

Community Acquired Pneumonia.; Treatment duration

Outcome Measures

Primary Outcomes (4)

• duration of the antibiotic treatment

  days taht the patient takes an antibiotic treatment, adding intravenous and oral

  30 days

• mortality

  the mortality in fifteen days

  15 days

• clinical cure

  resolution or improvement of symptoms and clinical signs related to pneumonia without a need for additional or alternative antibiotic treatment.

  10 days

• clinical cure

  resolution or improvement of symptoms and clinical signs related to pneumonia without a need for additional or alternative antibiotic treatment.

  30 days

Secondary Outcomes (6)

• 1- In-hospital mortality for any cause

  30 days

• Readmission

  30 days

• Days needed to reach clinical stability

  30 days

• Recurrence

  30 days

• Duration of hospital stay

  30 days

Study Arms (2)

INTERVENTION GROUP

EXPERIMENTAL

Patients with diagnosis of CAP with shorten treatment, defined as 5 days antibiotic treatment.

Other: Intervention group

CONTROL GROUP

ACTIVE COMPARATOR

Patients with diagnosis of CAP which antibiotic treatment duration will be not modified by their doctors.

Other: Control group

Interventions

Intervention group OTHER

Shorten the duration of antibiotic treatment from 7-10 days to 5 days.

INTERVENTION GROUP

Control group OTHER

Those antibiotic duration treatments which are not modified by their doctors.

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (4)

Hospital Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

Location

Hospital San Eloy

Barakaldo, Bizkaia, 48902, Spain

Location

Hospital Basurto

Bilbao, Bizkaia, 48013, Spain

Location

Hospital Galdakao

Galdakao, Bizkaia, 48960, Spain

Location

Related Publications (26)

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• Schuetz P, Christ-Crain M, Thomann R, Falconnier C, Wolbers M, Widmer I, Neidert S, Fricker T, Blum C, Schild U, Regez K, Schoenenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Mueller B; ProHOSP Study Group. Effect of procalcitonin-based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA. 2009 Sep 9;302(10):1059-66. doi: 10.1001/jama.2009.1297.

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MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• ALBERTO CAPELASTEGUI, PhD, MD

  Osakidetza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pneumology Service of Galdakao Hospital. PhD, MD.

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 10, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

ES (4)