Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

Phase 4

Terminated

• Conditions: Pneumonia, Pneumococcal

• Registration Number: NCT00429975
• Lead Sponsor: Hospital Mutua de Terrassa

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 Timeline

• Study Start: 2004-08
• Study Completion: 2005-09
• Status Verified: 2007-01
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Last Update Submitted: 2007-01-31
• Study First Posted: 2007-02-01
• Last Update Posted: 2007-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion

Secondary Outcome Measures

Name	Time	Method
the relationship between cytokine expression, clinical variables and severity of disease.

Trial Locations

Locations (1)

Hospital Mutua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain