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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
  Purpose

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


Condition Intervention Phase
Pneumonia, Pneumococcal
Drug: levofloxacin
Drug: ceftriaxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia

Resource links provided by NLM:


Further study details as provided by Hospital Mutua de Terrassa:

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

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

Estimated Enrollment: 45
Study Start Date: August 2004
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429975

Locations
Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Sponsors and Collaborators
Hospital Mutua de Terrassa
Fondo de Investigacion Sanitaria
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00429975     History of Changes
Other Study ID Numbers: FIS G03/103
Study First Received: January 31, 2007
Last Updated: January 31, 2007
Health Authority: SPAIN: AGEMED (Agencia Española del Medicamento y Productos Sanitarios.

Keywords provided by Hospital Mutua de Terrassa:
fluorquinolones,
b-lactams,
immunomodulation.

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumococcal
Bacterial Infections
Gram-Positive Bacterial Infections
Lung Diseases
Pneumococcal Infections
Pneumonia, Bacterial
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections
Ceftriaxone
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014