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Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

Information source: Hospital Mutua de Terrassa
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Last updated: January 31, 2007

Page last updated: August 23, 2015

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