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Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429975
Recruitment Status : Terminated
First Posted : February 1, 2007
Last Update Posted : February 1, 2007
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Mutua de Terrassa

Brief Summary:
The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine production in patients with pneumococcal pneumonia.

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumococcal Drug: levofloxacin Drug: ceftriaxone Phase 4

Detailed Description:

Bacterial alveolar invasion is followed by a compartmentalized inflammatory response. Data suggest that some antimicrobials may induce a differential release of cytokines, with the potential of either accelerating or down regulating cytokine production.

The aim of our study was to compare the effects of ceftriaxone compared with levofloxacin on cytokine systemic concentrations in patients with pneumococcal pneumonia.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia
Study Start Date : August 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Primary Outcome Measures :
  1. Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion

Secondary Outcome Measures :
  1. the relationship between cytokine expression, clinical variables and severity of disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with an acute febrile respiratory illness accompanied by a new radiographic infiltrate consistent with this diagnosis.
  • and with a confirmed pneumococcal aetiology

Exclusion Criteria:

  • age < 18 years,
  • pneumonia distal to endobronchial obstruction,
  • pulmonary tuberculosis,
  • bronchiectasis,
  • known allergy to B-lactams or fluoroquinolones,
  • underlying systemic autoimmune disease
  • immunocompromised states including patients on maintenance oral corticosteroids, HIV infection,
  • pregnancy,
  • patients that received antimicrobial therapy in the 15 days preceding the current episode and those who had received fluoroquinolones in the last month, or non steroidal anti-inflammatory therapy in the last two weeks.
  • Patients with renal failure (serum creatinine > 2 mg / dL),
  • and patients with a documented pneumococcal pneumonia in the previous 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00429975

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Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Sponsors and Collaborators
Hospital Mutua de Terrassa
Fondo de Investigacion Sanitaria
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Principal Investigator: ESTHER CALBO, MD Hospital Mutua de Terrassa
Principal Investigator: MARIONA XERCAVINS, MD Hospital Mutua de Terrassa
Principal Investigator: EVA CUCHI, MD Hospital Mutua de Terrassa
Principal Investigator: MONICA RODRIGUEZ-CARBALLEIRA, PhD Hospital Mutua de Terrassa
Study Director: JAVIER GARAU, PhD Hospital Mutua de Terrassa
Layout table for additonal information Identifier: NCT00429975    
Other Study ID Numbers: FIS G03/103
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: February 1, 2007
Last Verified: January 2007
Keywords provided by Hospital Mutua de Terrassa:
Additional relevant MeSH terms:
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Pneumonia, Pneumococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors