Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00429975
Recruitment Status : Terminated
First Posted : February 1, 2007
Last Update Posted : February 1, 2007
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Mutua de Terrassa

Tracking Information
First Submitted Date  ICMJE January 31, 2007
First Posted Date  ICMJE February 1, 2007
Last Update Posted Date February 1, 2007
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
the relationship between cytokine expression, clinical variables and severity of disease.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia
Official Title  ICMJE Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia
Brief Summary The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine production in patients with pneumococcal pneumonia.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia, Pneumococcal
Intervention  ICMJE
  • Drug: levofloxacin
  • Drug: ceftriaxone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: January 31, 2007)
45
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00429975
Other Study ID Numbers  ICMJE FIS G03/103
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hospital Mutua de Terrassa
Collaborators  ICMJE Fondo de Investigacion Sanitaria
Investigators  ICMJE
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
PRS Account Hospital Mutua de Terrassa
Verification Date January 2007

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