Pneumonia, PneumococcalPhase 4NCT00429975
Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia
A Phase 4 study testing levofloxacin and ceftriaxone in people with Pneumonia, Pneumococcal, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial summary
The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine production in patients with pneumococcal pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pneumococcal
- What is being tested?
- levofloxacin and ceftriaxone
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2004to Sep 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with an acute febrile respiratory illness accompanied by a new radiographic infiltrate consistent with this diagnosis.
- and with a confirmed pneumococcal aetiology
Who cannot join
- age < 18 years,
- pneumonia distal to endobronchial obstruction,
- pulmonary tuberculosis,
- bronchiectasis,
- known allergy to B-lactams or fluoroquinolones,
- underlying systemic autoimmune disease
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia
The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine production in patients with pneumococcal pneumonia.
Read the 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.
- Conditions
- Pneumonia, Pneumococcal
- Being tested
- levofloxacin, ceftriaxone
- Keywords
- fluorquinolones,, b-lactams,, immunomodulation.
- Medical subject headings
- Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacinDrug
ceftriaxoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
Secondary outcomes (1)
the relationship between cytokine expression, clinical variables and severity of disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startAug 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, PneumococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Investigators
- ESTHER CALBO, MD, Principal investigator, Hospital Mutua de TerrassaMONTSERRAT ALSINA, MD, Principal investigator, HOSPITAL MUTUA TERRASSAMARIONA XERCAVINS, MD, Principal investigator, Hospital Mutua de TerrassaEVA CUCHI, MD, Principal investigator, Hospital Mutua de TerrassaMONICA RODRIGUEZ-CARBALLEIRA, PhD, Principal investigator, Hospital Mutua de TerrassaJAVIER GARAU, PhD, Study director, Hospital Mutua de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429975
- Sponsor's protocol ID
- FIS G03/103
- Status last verified
- Jan 2007
- First submitted
- 31 Jan 2007
- Last updated
- 1 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia
- ClinicalTrials.gov ID
- NCT00429975
- Acronym / sponsor ID
- FIS G03/103
- Conditions
- Pneumonia, Pneumococcal
- Keywords
- fluorquinolones,, b-lactams,, immunomodulation.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- Aug 2004
- Study completion
- Sep 2005
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with an acute febrile respiratory illness accompanied by a new radiographic infiltrate consistent with this diagnosis.
- and with a confirmed pneumococcal aetiology
Key exclusion criteria (11 listed)
- age < 18 years,
- pneumonia distal to endobronchial obstruction,
- pulmonary tuberculosis,
- bronchiectasis,
- known allergy to B-lactams or fluoroquinolones,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levofloxacin | Drug | – |
| ceftriaxone | Drug | – |
Primary outcome
Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
1 secondary outcome
the relationship between cytokine expression, clinical variables and severity of disease.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ESTHER CALBO, MD principal investigator
Hospital Mutua de Terrassa
MONTSERRAT ALSINA, MD principal investigator
HOSPITAL MUTUA TERRASSA
MARIONA XERCAVINS, MD principal investigator
Hospital Mutua de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levofloxacin and ceftriaxone in people with Pneumonia, Pneumococcal, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2007.