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OpenTrials
Completed

NCT Number: NCT00818610

Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia

The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HFR-Fribourg, Hôpital Cantonal, Fribourg, Canton of Fribourg, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >=18 years
  • New infiltrate on chest X-ray, unexplained by another disease process
  • Presence of at least two of the following findings suggestive of pneumonia: fever or hypothermia, new or increasing cough, sputum production, pleuritic chest pain, tachypnea, dyspnea or focal signs on chest examination
  • Need for hospitalization as defined by the emergency physician in charge of the patient

Exclusion criteria

  • Allergy to one of the study drugs
  • Pregnancy
  • Severe immunosuppression
  • Recent (<14 d) hospitalization, or currently hospitalized since > 48 hours
  • Residency in a nursing home
  • Previous use of more than 24 hours of any antibiotic
  • Severe community-acquired pneumonia

Treatment and study plan

Beta lactam (amoxicillin / clav. acid OR cefuroxime)

Drug

1.2 g 4x/d OR 1.5 g 3x/d IV

Other names: Augmentin, Zinacef

Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)

Drug

1.2 g 4x/d OR 1.5 g 3x/d IV AND 0.5 g 2x/d IV/PO

Other names: Augmentin, Zinacef, Klacid

Primary outcomes

  1. Time to Clinical Stability (hours)

    Time frame: 30 days

Secondary outcomes

  1. All cause mortality

    Time frame: in-hospital, at 30 and at 90 days

  2. length of stay

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Swiss National Fund for Scientific Research

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

Beta-lactam Monotherapy Versus Beta-lactam - Macrolide Association as Empiric Antibiotherapy Strategies in Non-severe Hospitalized Community-acquired Pneumonia: a Randomized, Non-inferiority, Open Trial.

Acronym: BICAP

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2009
Registry last updated
Apr 25, 2013

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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