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Trial record 1 of 3 for:    9459469 [PUBMED-IDS]
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Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia (CAP5)

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ClinicalTrials.gov Identifier: NCT04089787
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Benfield, Hvidovre University Hospital

Brief Summary:

CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (CAP) in hospitalized adult patients based on clinical stability criteria.

Five days after initiation of antimicrobial therapy for CAP, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician.

The primary outcome is 90-day readmission-free survival which will be tested with a non-inferiority margin of 6%.


Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Other: Intervention Other: Control Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Shortened antibiotic treatment of 5 days
Other: Intervention
Shortened antibiotic treatment of 5 days

Active Comparator: Control group
Antibiotic treatment of 7 days or longer at the discretion of the treating physician
Other: Control
Antibiotic treatment of 7 days or longer at the discretion of the treating physician




Primary Outcome Measures :
  1. 90-day readmission-free survival [ Time Frame: within 90 days ]

Secondary Outcome Measures :
  1. Duration of antibiotic treatment [ Time Frame: within 90 days ]
    Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy

  2. Length of hospital stay [ Time Frame: within 90 days ]
    Days from the date of hospital admission for pneumonia to the date of discharge

  3. Antibiotic adverse events [ Time Frame: within 90 days ]
    Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia

  4. Serious adverse events [ Time Frame: within 90 days ]
    Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines

  5. Major complications [ Time Frame: within 90 days ]
    Number of participants with major complications, including pleural effusion, pleural empyema, lung abscess, respiratory failure, severe sepsis, renal failure, use of non-invasive or invasive ventilation, need for vasopressors, and intensive care unit (ICU) admission

  6. Use of antimicrobials after discharge [ Time Frame: within 90 days ]
    Days of antibiotic treatment for any reason after hospital discharge

  7. Post-discharge follow-up visits [ Time Frame: within 90 days ]
    Number of participants with medical visits after hospital discharge, including visits at the outpatient clinic and at the general practitioner

  8. Readmissions [ Time Frame: days 30 and 90 ]
    Number of participants with readmissions for reasons related to or unrelated to pneumonia

  9. Mortality [ Time Frame: in-hospital, days 30 and 90 ]
    Number of deaths by any cause



Information from the National Library of Medicine

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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:

  • Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray and at least one symptom compatible with pneumonia (cough, fever, dyspnoea and/or chest pain)
  • Initiation of antibiotics within 8 hours of the time of the chest X-ray with an infiltrate
  • Age ≥ 18 years
  • Afebrile (temperature ≤ 37.8 °C) for 48 hours at randomization
  • Clinically stable at randomization (systolic blood pressure ≥ 90 mm Hg, heart rate ≤ 100/min., respiratory rate ≤ 24/min., peripheral oxygen saturation ≥ 90%)

Exclusion Criteria:

  • Immunosuppression (HIV-positive, neutropenia, corticosteroid treatment (≥10 mg/day of prednisone or the equivalent for >30 days), chemotherapy, immunosuppressive agents, immunosuppressed after solid organ transplantation, asplenia)
  • Hospitalization during the previous 14 days
  • Antibiotic treatment (>2 days) within the past 30 days
  • Uncommon cause requiring longer duration of antimicrobial therapy (Pseudomonas aeruginosa, Staphylococcus aureus, Mycobacterium spp., fungi)
  • Extrapulmonary infection (e.g. endocarditis, meningitis, or abscess)
  • Multilobar involvement
  • Pleural empyema or lung abscess
  • Pleural effusion requiring drainage tube
  • Intensive care unit (ICU) admittance
  • Pregnancy and breastfeeding

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): NCT04089787


Contacts
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Contact: Simone Bastrup Israelsen, MD +45 40335495 simone.elisabeth.bastrup.israelsen.02@regionh.dk
Contact: Thomas Benfield, MD DMSc thomas.lars.benfield@regionh.dk

Locations
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Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark, 9000
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8200
Herlev Hospital Not yet recruiting
Herlev, Denmark, 2730
Nordsjællands Hospital Not yet recruiting
Hillerød, Denmark, 3400
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Simone Bastrup Israelsen, MD       simone.elisabeth.bastrup.israelsen.02@regionh.dk   
Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Silkeborg Hospital Not yet recruiting
Silkeborg, Denmark, 8600
Sponsors and Collaborators
Thomas Benfield
  Study Documents (Full-Text)

Documents provided by Thomas Benfield, Hvidovre University Hospital:
Statistical Analysis Plan  [PDF] October 21, 2019


Publications:

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Responsible Party: Thomas Benfield, Clinical Professor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04089787     History of Changes
Other Study ID Numbers: H-19014479
2019-000404-15 ( EudraCT Number )
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Thomas Benfield, Hvidovre University Hospital:
Community-acquired pneumonia
Treatment duration
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Pneumonia, Bacterial
Anti-Infective Agents
Anti-Bacterial Agents
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