Clinical trial NCT00429975: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pneumonia, Pneumococcal
Keywords: fluorquinolones,
b-lactams,
immunomodulation.
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2007-02-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
Secondary outcomes:
measure: the relationship between cytokine expression, clinical variables and severity of disease.
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
Study officials:
affiliation: Hospital Mutua de Terrassa
name: ESTHER CALBO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL MUTUA TERRASSA
name: MONTSERRAT ALSINA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Mutua de Terrassa
name: MARIONA XERCAVINS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Mutua de Terrassa
name: EVA CUCHI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Mutua de Terrassa
name: MONICA RODRIGUEZ-CARBALLEIRA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Mutua de Terrassa
name: JAVIER GARAU, PhD
role: STUDY_DIRECTOR
References: