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Completed

NCT Number: NCT01964495

Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)

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.

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Key information

Conditions

Community Acquired Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Centre Alkmaar, Alkmaar, North Holland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female patients with a diagnosis of CAP and all criteria listed below:

  • Age 18 or above, no upper age limit will be employed.
  • Patients must require hospitalisation.
  • Clinical presentation of an acute illness with one or more of the following symptoms:
  • Temperature ≥ 38.0 ⁰C (100.4°F)
  • Dyspnoea
  • Cough (with or without expectoration of sputum)
  • Chest pain
  • Malaise or fatigue
  • Myalgia
  • Gastro-intestinal symptoms
  • Rales, rhonchi or wheezing
  • Egophony or bronchial breath sounds
  • New consolidation(s) on the chest radiograph.
  • Written informed consent obtained.
  • (Pre-event) Life expectancy > 30 days

Exclusion criteria

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

  • (Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants).
  • Active neoplastic disease.
  • Obstruction pneumonia (e.g. from lung cancer).
  • Aspiration pneumonia.
  • Pneumonia that developed within 8 days after hospital discharge.
  • Unable and/or unlikely to comprehend and/or follow the protocol.
  • Pregnant and/or lactating women.
  • Other infection that requires treatment with antibiotics

Treatment and study plan

Discontinuation of treatment according to CRP levels

Drug

The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.

Other names: Broad spectrum antibiotics, Small spectrum antibiotics

Discontinuation of treatment according to PCT levels

Drug

The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.

Other names: Broad spectrum antibiotics, Small spectrum antibiotics

Treatment according to current guidelines

Drug

Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.

Other names: Broad spectrum antibiotics, Small spectrum antibiotics

Primary outcomes

  1. Length of antibiotic treatment

    Time frame: End of the study

Secondary outcomes

  1. Length of stay

    Time frame: End of the study

  2. Clinical response

    Time frame: End of the study

    Cure - resolution or improvement of symptoms and clinical signs related to pneumonia without the need for additional or alternative antibiotic therapy

    Failure - persistence or progression of all signs and symptoms of the acute process after randomisation or the development of a new pulmonary or extrapulmonary respiratory tract infection, or the progression of abnormalities on chest radiograph after randomisation, or death due to pneumonia, or the inability to complete the study owing to adverse events

    Indeterminate - patient receives less than 80% of the study drug for reasons other than clinical failure, a concomitant infection outside the respiratory tract requiring antibiotic treatment, lost to follow-up, or death unrelated to the primary diagnosis.

  3. 30-day mortality

    Time frame: End of the study, periodically by the DSMB

    All cause

  4. Time to clinical stability

    Time frame: End of the study

    Patients are considered clinically stable if they fulfill all of these criteria: Temperature equal to or below 37.8 degrees celsius, heart rate equal to or below 100 beats per minute, respiratory rate equal to or below 24 breaths per minute, systolic blood pressure equal to or above 90 mmHg, arterial oxygen saturation equal to or above 90 percent or pO2 equal to or above 60 mmHg on room air, ability to maintain oral intake, normal mental status.

  5. Relapse rate

    Time frame: End of the study

Sponsors and collaborators

Lead sponsor

Medical Center Alkmaar

Other

Collaborators

  • Foreest Medical School
  • Pulmoscience

Registry information

Acronym: REDUCE

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2013
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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