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Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia (CAP5)

Primary Purpose

Community-acquired Pneumonia

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
Thomas Benfield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Community-acquired pneumonia, Treatment duration, Pneumonia, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Bacterial Infections, Pneumonia, Bacterial, Anti-Infective Agents, Anti-Bacterial Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 12 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)
  • Pleural empyema or lung abscess
  • Pleural effusion requiring drainage tube
  • Intensive care unit (ICU) admittance
  • Pregnancy and breastfeeding

Sites / Locations

  • Aalborg University HospitalRecruiting
  • Bispebjerg HospitalRecruiting
  • Gentofte HospitalRecruiting
  • Herlev HospitalRecruiting
  • Nordsjællands HospitalRecruiting
  • Hvidovre HospitalRecruiting
  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Shortened antibiotic treatment of 5 days

Antibiotic treatment of 7 days or longer at the discretion of the treating physician

Outcomes

Primary Outcome Measures

90-day readmission-free survival

Secondary Outcome Measures

Duration of antibiotic treatment
Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy
Length of hospital stay
Days from the date of hospital admission for pneumonia to the date of discharge
Antibiotic adverse events
Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia
Serious adverse events
Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Major complications
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
Use of antimicrobials after discharge
Days of antibiotic treatment for any reason after hospital discharge
Post-discharge follow-up visits
Number of participants with medical visits after hospital discharge, including visits at the outpatient clinic and at the general practitioner
Readmissions
Number of participants with readmissions for reasons related to or unrelated to pneumonia
Mortality
Number of deaths by any cause

Full Information

First Posted
September 11, 2019
Last Updated
March 6, 2023
Sponsor
Thomas Benfield
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1. Study Identification

Unique Protocol Identification Number
NCT04089787
Brief Title
Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia
Acronym
CAP5
Official Title
Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Benfield

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
Community-acquired pneumonia, Treatment duration, Pneumonia, Lung Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Bacterial Infections, Pneumonia, Bacterial, Anti-Infective Agents, Anti-Bacterial Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
564 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Shortened antibiotic treatment of 5 days
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Antibiotic treatment of 7 days or longer at the discretion of the treating physician
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
Shortened antibiotic treatment of 5 days
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Antibiotic treatment of 7 days or longer at the discretion of the treating physician
Primary Outcome Measure Information:
Title
90-day readmission-free survival
Time Frame
within 90 days
Secondary Outcome Measure Information:
Title
Duration of antibiotic treatment
Description
Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy
Time Frame
within 90 days
Title
Length of hospital stay
Description
Days from the date of hospital admission for pneumonia to the date of discharge
Time Frame
within 90 days
Title
Antibiotic adverse events
Description
Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia
Time Frame
within 90 days
Title
Serious adverse events
Description
Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Time Frame
within 90 days
Title
Major complications
Description
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
Time Frame
within 90 days
Title
Use of antimicrobials after discharge
Description
Days of antibiotic treatment for any reason after hospital discharge
Time Frame
within 90 days
Title
Post-discharge follow-up visits
Description
Number of participants with medical visits after hospital discharge, including visits at the outpatient clinic and at the general practitioner
Time Frame
within 90 days
Title
Readmissions
Description
Number of participants with readmissions for reasons related to or unrelated to pneumonia
Time Frame
days 30 and 90
Title
Mortality
Description
Number of deaths by any cause
Time Frame
in-hospital, days 30 and 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 12 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) Pleural empyema or lung abscess Pleural effusion requiring drainage tube Intensive care unit (ICU) admittance Pregnancy and breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Bastrup Israelsen, MD
Phone
+45 40335495
Email
simone.elisabeth.bastrup.israelsen.02@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Benfield, MD DMSc
Email
thomas.lars.benfield@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Bastrup Israelsen, MD
Organizational Affiliation
Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lone Mygind, MD
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Knudsen, MD
Facility Name
Gentofte Hospital
City
Gentofte
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pernille Ravn, MD
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulla Balslev Handest, MD
Facility Name
Nordsjællands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgitte Lindegaard Madsen, MD
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Bastrup Israelsen, MD
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isik Somuncu Johansen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Trial data will be made available in anonymous form at public clinical trial databases when the trial has ended. Anonymized patient-level data and other detailed information will be provided by reasonable request to the principal investigator.
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Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia

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