Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

This study has been terminated.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier:
NCT00429975
First received: January 31, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 31, 2007
January 31, 2007
August 2004
Not Provided
Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
Same as current
No Changes Posted
the relationship between cytokine expression, clinical variables and severity of disease.
Same as current
Not Provided
Not Provided
 
Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia
Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pneumonia, Pneumococcal
  • Drug: levofloxacin
  • Drug: ceftriaxone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
September 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00429975
FIS G03/103
Not Provided
Not Provided
Hospital Mutua de Terrassa
Fondo de Investigacion Sanitaria
Principal Investigator: ESTHER CALBO, MD Hospital Mutua de Terrassa
Principal Investigator: MONTSERRAT ALSINA, MD HOSPITAL MUTUA 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
Hospital Mutua de Terrassa
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP