Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia

Thomas Benfield395 enrolled

Overview

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. Three to 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 survival which will be tested with a non-inferiority margin of 6%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

395

Conditions

Community-acquired Pneumonia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray and/or CT scan 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, directed at lower respiratory tract pathogens * 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

Locations (7)

Aalborg University Hospital

Aalborg, Denmark

Bispebjerg Hospital

Copenhagen, Denmark

Gentofte Hospital

Gentofte Municipality, Denmark

Herlev Hospital

Herlev, Denmark

Nordsjællands Hospital

Hillerød, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

90-day survival

Time frame: within 90 days

Secondary Outcomes

Duration of antibiotic treatment

Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy

Time frame: within 90 days

Length of hospital stay

Days from the date of hospital admission for pneumonia to the date of discharge

Time frame: within 90 days

Antibiotic adverse events

Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia

Time frame: within 90 days

Serious adverse events

Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines

Time frame: within 90 days

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

Time frame: within 90 days

Use of antimicrobials after discharge

Days of antibiotic treatment for any reason after hospital discharge

Time frame: within 90 days

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

Time frame: within 90 days

Readmissions

Number of participants with readmissions for reasons related to or unrelated to pneumonia

Time frame: days 30 and 90

Mortality

Number of deaths by any cause

Time frame: in-hospital, days 30 and 90