Clinical Pathway Based on Procalcitonin Levels for the Management of Community-acquired Pneumonia in Outpatients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A clinical protocol was developed for the management of adult outpatients with community-acquired pneumonia (CAP) and Pneumonia Severity Index risk classes I-II. Patients are assigned to oral azithromycin or levofloxacin according to procalcitonin (PCT) levels measured with a rapid point-of-care method. When PCT levels are \<0.5 ng/ml, azithromycin, 500 mg/day is given orally for 5 days; if PCT is ≥0.5 ng/ml, levofloxacin, 500 mg/day is given orally for 7 days

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Procalcitonin Aided Antimicrobial Therapy vs Standard of Care

NCT06960044

Lower Respiratory Tract Infection (LRTI)

NOT_YET_RECRUITING NA

POCT PCT in Outpatient LRTI

NCT05380869

Antimicrobial Stewardship Exacerbation of Allergic Asthma Exacerbation Copd +2 more

COMPLETED NA

Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia

NCT03452826

Community-acquired Pneumonia

COMPLETED NA

Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

NCT00429975

Pneumonia, Pneumococcal

TERMINATED PHASE4

Treatment of Mycobacterium Xenopi Pulmonary Infection

NCT01298336

Atypical; Mycobacterium, Pulmonary, Tuberculous

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A clinical protocol was developed in collaboration with the hospital's Emergency Department for the management of adult outpatients with community-acquired pneumonia (CAP). Patients are assigned to 2 treatment categories according to the plasma procalcitonin (PCT) values.

Treatment assignment:

1. PCT\<0.5 ng/ml: azithromycin, 500 mg/day orally for 5 days
2. PCT≥0.5ng/ml: levofloxacin, 500 mg/day orally for 7 days

Laboratory and microbiological studies:

In the ED, patients with signs and symptoms of pneumonia have a blood sample collected for routine biochemical and hematological determinations, and PCT concentration measurement.

Rapid testing for the determination of PCT are performed with BRAHMS PCT-Q, an immunochromatografic test for the semi-quantitative detection of PCT in serum (BRAHMS GmbH, 16761 Hennigsdorf, Germany). PCT concentration ranges are the following: \<0.5 ng/ml; ≥ 0.5 ng/ml; ≥2 ng/ml; ≥10 ng/ml.

The etiological diagnostic workup includes obtaining sputum samples from patients with productive cough, and a urine sample for detection of S. pneumoniae and Legionella pneumophila serogroup 1 antigens by immunochromatographic assays (Binax NOW, Alere Healthcare SLU, Spain). Only qualified sputum samples, as defined according to standard criteria (presence of \>25 WBC and \<10 squamous cells per low-power magnification field \[x10\]) are evaluated. Serum samples (obtained during the acute stage of illness and 4 weeks later) are collected and frozen at -80ºC for ulterior serological testing. An indirect chemiluminescent immunoassay (VirClia® Monotest, Vircell, S.L., Granada, Spain) is performed to detect IgG antibodies against Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila and Coxiella burnetii. Calculation of cutoff values and interpretation of the results are performed in accordance with the instructions of the manufacturer. The diagnostic criteria are either a seroconversion (index value from negative to positive) or a significant increase in the index value (≥threefold) in paired samples. All assays are performed and analyzed blindly by the same person.

Follow-up and outcome measures:

After treatment has been assigned, patients are referred to the outpatients clinic, where they are seen within the following 24 hours (Visit 2). A phone visit (Visit 3) is scheduled on day 7, and the last programmed visit on day 30 at the clinic (Visit 4). Patients are instructed to visit the outpatients' clinic if their clinical status worsens or fever persists more than 48 hours after the first visit. Cure is defined as an improvement or lack of progression of baseline radiographic findings at the end of therapy (EOT) and resolution of signs, including chest X-Ray, and symptoms of pneumonia at visit 4. Failure is defined as persistence or progression of signs and symptoms or progression of radiological signs of pneumonia at EOT, persistent infiltrate on X-Ray at visit 4, and initiation within 2 calendar days of the initial antibiotic therapy of a different potentially effective antibiotic, death on or after day 3 attributable to primary infection, or relapsed infection at visit 4. Antibiotic change requirement due to toxicity, and need for hospital admission is also recorded.

In addition to the short-term outcome, the long-term (3-year) outcome of the patients is assessed through a structured telephone interview.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Community-acquired Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Azithromycin/levofloxacin

Azithromycin or levofloxacin are given according to serum procalcitonin levels

Group Type OTHER

Azithromycin

Intervention Type DRUG

Patients are given oral azithromycin when procalcitonin levels are \< 0.5 ng/ml

Levofloxacin

Intervention Type DRUG

Patients are given oral levofloxacin when procalcitonin levels are \>= 0.5 ng/ml.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Azithromycin

Patients are given oral azithromycin when procalcitonin levels are \< 0.5 ng/ml

Intervention Type DRUG

Levofloxacin

Patients are given oral levofloxacin when procalcitonin levels are \>= 0.5 ng/ml.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zithromax, Zmax Tavanic, Levaquin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Fever with or without respiratory symptoms
* New infiltrate on chest radiograph
* Pneumonia Severity Index (PSI) score ≤ 70 (risk classes I and II).

Exclusion Criteria

* PSI risk classes III-V
* Age ≥65 years
* Comorbidity (diabetes, chronic obstructive pulmonary disease, chronic renal disease, neoplasia, immunosuppression including HIV infection, chronic heart failure or cirrhosis)
* White blood cell count ≥20.0 x 109/L
* Pleural effusion
* Bilateral infiltrates
* Previous failure or allergy to macrolides or quinolones
* Need for oxygen therapy -

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes