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Reduction of antibiotic therapy by biomarkers in patients with CAP episodes

Reduction of antibiotic therapy by biomarkers in patients with CAP episodes - REDUCE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45194
Enrollment
468
Registered
2013-10-15
Start date
2013-12-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Interventions

The 3 different treatment strategies are as follows: 1. Treatment according to common practice: often a 7 day course of antibiotics. 2. Treatment with antibiotics for at least 3 days according to curr

Sponsors

Medisch Centrum Alkmaar
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male and female patients with a diagnosis of CAP and all criteria listed below: 1. Age 18 or above, no upper age limit will be employed. 2. Patients must require hospitalisation. 3. Clinical presentation of an acute illness with one or more of the following symptoms: a. Temperature * 38.0 *C (100.4°F) b. Dyspnoea c. Cough (with or without expectoration of sputum) d. Chest pain e. Hemoptysis f. Malaise or fatigue g. Myalgia h. Gastro-intestinal symptoms i. Rales, rhonchi or wheezing j. Egophony or bronchial breath sounds 4. New consolidation(s) on the chest radiograph. 5. Written informed consent obtained. 6. (Pre-event) Life expectancy > 30 days.

Exclusion criteria

Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Severe immunosuppression (HIV infection, chemotherapy). 2. Active neoplastic disease. 3. Obstruction pneumonia (e.g. from lung cancer). 4. Aspiration pneumonia. 5. Pneumonia that developed within 8 days after hospital discharge. 6. Unable and/or unlikely to comprehend and/or follow the protocol. 7. Pregnant and/or lactating women.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to determine whether the CRP and PCT strategies can be used to safely and effectively reduce the duration of antibiotic treatment in patients with CAP requiring hospitalisation. The diagnosis CAP will be made if a non-hospitalized person presents with one or more symptoms associated with a lower respiratory tract infection and a new infiltrate on the chest radiograph. These symptoms are: temperature greater than 38°C (100.4°F); cough with or without sputum; hemoptysis; pleuritic chest pain; dyspnea; malaise or fatigue; myalgia; gastro-intestinal symptoms; rales, rhonchi or wheezing; egophony or bronchial breath sounds.

Secondary

MeasureTime frame
The secondary objectives of this study are to assess the length of hospital stay, clinical response, 30-day mortality, time to clinical stability and relapse rate within 30 days. A relapse is defined as new or worsening symptoms indicative of pneumonia after initial improvement on therapy. Furthermore several biomarkers and genetic polymorfisms for corticosteroid-receptors will be assessed at the end of the study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)