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

Sponsor

Thomas Benfield (Other)

Overall Status

Recruiting

CT.gov ID

NCT04089787

Collaborator

(none)

564

Enrollment

Locations

Arms

29.4

Anticipated Duration (Months)

70.5

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

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%.

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia	Other: Intervention Other: Control	Phase 4

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 18, 2019

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

90-day readmission-free survival [within 90 days]

Secondary Outcome Measures

Duration of antibiotic treatment [within 90 days]
Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy
Length of hospital stay [within 90 days]
Days from the date of hospital admission for pneumonia to the date of discharge
Antibiotic adverse events [within 90 days]
Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia
Serious adverse events [within 90 days]
Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Major complications [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
Use of antimicrobials after discharge [within 90 days]
Days of antibiotic treatment for any reason after hospital discharge
Post-discharge follow-up visits [within 90 days]
Number of participants with medical visits after hospital discharge, including visits at the outpatient clinic and at the general practitioner
Readmissions [days 30 and 90]
Number of participants with readmissions for reasons related to or unrelated to pneumonia
Mortality [in-hospital, days 30 and 90]
Number of deaths by any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Aalborg University Hospital	Aalborg	Denmark	9000
2	Aarhus University Hospital	Aarhus	Denmark	8200
3	Gentofte Hospital	Gentofte	Denmark	2900
4	Herlev Hospital	Herlev	Denmark	2730
5	Nordsjællands Hospital	Hillerød	Denmark	3400
6	Hvidovre Hospital	Hvidovre	Denmark	2650
7	Odense University Hospital	Odense	Denmark	5000
8	Silkeborg Hospital	Silkeborg	Denmark	8600