Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia
Information source: Hospital Mutua de Terrassa
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Pneumococcal
Intervention: levofloxacin (Drug); ceftriaxone (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Hospital Mutua de Terrassa Official(s) and/or principal investigator(s):
ESTHER CALBO, MD, Principal Investigator, Affiliation: Hospital Mutua de Terrassa
MONTSERRAT ALSINA, MD, Principal Investigator, Affiliation: HOSPITAL MUTUA TERRASSA
MARIONA XERCAVINS, MD, Principal Investigator, Affiliation: Hospital Mutua de Terrassa
EVA CUCHI, MD, Principal Investigator, Affiliation: Hospital Mutua de Terrassa
MONICA RODRIGUEZ-CARBALLEIRA, PhD, Principal Investigator, Affiliation: Hospital Mutua de Terrassa
JAVIER GARAU, PhD, Study Director, Affiliation: Hospital Mutua de Terrassa
Summary
The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine
production in patients with pneumococcal pneumonia.
Clinical Details
Official title: Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
Secondary outcome: the relationship between cytokine expression, clinical variables and severity of disease.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hospital Mutua De Terrassa, TERRASSA, BARCELONA 08221, Spain
Additional Information
Starting date: August 2004
Ending date: September 2005
Last updated: January 31, 2007
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