Clinical trial NCT01964495: Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
Official title: Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Acquired Pneumonia
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
Collaborators: name: Foreest Medical School
name: Pulmoscience
First posted: 2013-10-17
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate two different treatment strategies in patients admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be effective in reducing the length of antibiotic treatment.


Eligibility 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:

   1. Temperature ≥ 38.0 ⁰C (100.4°F)
   2. Dyspnoea
   3. Cough (with or without expectoration of sputum)
   4. Chest pain
   5. Malaise or fatigue
   6. Myalgia
   7. Gastro-intestinal symptoms
   8. Rales, rhonchi or wheezing
   9. 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:

Subjects presenting with any of the following will not be included in the study:

1. (Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants).
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.
8. Other infection that requires treatment with antibiotics

Primary outcomes:
measure: Length of antibiotic treatment
timeFrame: End of the study
Secondary outcomes:
measure: Length of stay
timeFrame: End of the study
measure: Clinical response
timeFrame: End of the study
measure: 30-day mortality
timeFrame: End of the study, periodically by the DSMB
measure: Time to clinical stability
timeFrame: End of the study
measure: Relapse rate
timeFrame: End of the study
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Centre Alkmaar
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Slotervaart Hospital
state: Noord Holland
city: Zwolle
country: Netherlands
facility: ISALA clinics
state: Overijssel
Study officials:
affiliation: Medisch Centrum Alkmaar
name: Ruud Duijkers, MSc, MD
role: STUDY_DIRECTOR
affiliation: Medisch Centrum Alkmaar
name: Wim G Boersma, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Slotervaart ziekenhuis
name: Dominic Snijders, MSc, PhD, MD
role: STUDY_CHAIR
References: