Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

Pneumonia, Pneumococcal Clinical Trial

Official title:

Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00429975
• Other study ID #: FIS G03/103
• Status: Terminated
• Phase: Phase 4
• First received: January 31, 2007
• Last updated: January 31, 2007
• Start date: August 2004
• Est. completion date: September 2005

Study information

• Verified date: January 2007
• Source: Hospital Mutua de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Health authority: SPAIN: AGEMED (Agencia Española del Medicamento y Productos Sanitarios.
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Pneumococcal

Intervention

Drug:
• levofloxacin

• ceftriaxone

Locations

Country	Name	City	State
Spain	Hospital Mutua de Terrassa	Terrassa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Mutua de Terrassa	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
Secondary	the relationship between cytokine expression, clinical variables and severity of disease.