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Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

Primary Purpose

Pneumonia, Pneumococcal

Status

Terminated

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

levofloxacin

ceftriaxone

About this trial

This is an interventional treatment trial for Pneumonia, Pneumococcal focused on measuring fluorquinolones,, b-lactams,, immunomodulation.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Mutua de Terrassa

Outcomes

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.

Full Information

NCT ID

NCT00429975

First Posted

January 31, 2007

Last Updated

January 31, 2007

Sponsor

Hospital Mutua de Terrassa

Collaborators

Fondo de Investigacion Sanitaria

1. Study Identification

Unique Protocol Identification Number

NCT00429975

Brief Title

Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Terminated

Study Start Date

August 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Mutua de Terrassa

Collaborators

Fondo de Investigacion Sanitaria

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Pneumococcal

Keywords

fluorquinolones,, b-lactams,, immunomodulation.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

levofloxacin

Intervention Type

Drug

Intervention Name(s)

ceftriaxone

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: