StaphylococcusPhase 3NCT01875263
Efficacy of a Short-term Sequential Therapy in Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.
A Phase 3 study testing Cloxacilin, Cloxacillin and Levofloxacin in people with Staphylococcus, run by Fundación Pública Andaluza Progreso y Salud at 11 sites in Spain.
Trial summary
Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established clinical and microbiological criteria. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Staphylococcus
- What is being tested?
- Cloxacilin, Cloxacillin and Levofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 11 sitesSpain
- Study dates
- May 2013to Nov 2014
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years with a minimum weight of 40 kg.
- Microbiological Isolation of S. aureus susceptible to meticillin.
- Start antibiotic treatment with drugs active against S. aureus within 72 hours from the onset of clinical manifestations.
- Women of childbearing potential, negative pregnancy test negative serum or urine or statement is not pregnant.
- Prescription prior treatment must be independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice.
Who cannot join
- Polymicrobial bacteremia.
- Neutropenic patients.
- Patients addicted to intravenous drugs.
- Patients with malignancies with expected survival less than 6 months.
- Severe allergy to beta-lactams or fluoroquinolones.
- Creatinine clearance <20ml/min.
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- Need for hemodialysis, peritoneal dialysis or plasmapheresis.
- Clinical signs of deep infection in the first five days of treatment (mucocutaneous lesions suggestive of IE, embolic events, suppurative thrombophlebitis.
- Predictors of bacteremia complicated:
- Positive blood cultures for 48-96 hours of starting treatment antistaphylococcal
- Clinical Instability
- Signs of sepsis or persistent fever at day 4 of treatment
- Existence of valvular or vascular prosthetic joints, vascular catheter not removed within three days
- Heart disease predisposing to endocarditis.
- Patients presenting diagnosis concomitant infection by another organism.
- Pregnant or breast-feeding.
- Patients with epilepsy.
- Patients with a history of tendon disorders related to fluoroquinolone administration.
- Not have signed informed consent.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario Virgen de las Nieves
Granada
Complejo Hospitalario de Huelva
Huelva
Hospital Can Misses
Ibiza Town
Hospital de Jerez de la Frontera
Jerez de la Frontera, Cádiz
Hospital Comarcal Carlos Haya
Málaga
Hospital de Antequera
Málaga
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Costa del Sol
Marbella, Málaga
Hospital Universitario Virgen de Valme
Seville
Hospital Universitario Virgen del Rocío
Seville
About this study
Official title: Efficacy of a Short-term Sequential Therapy Versus Intravenous Standard Treatment for Patients With Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.
Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established clinical and microbiological criteria.
- Conditions
- Staphylococcus
- Being tested
- Cloxacilin, Cloxacillin, Levofloxacin
- Keywords
- catheter-related bacteremia, SAMS, catheter related bacteremia, susceptible, aureus meticillin
- Medical subject headings
- Short Stature, Auditory Canal Atresia, Mandibular Hypoplasia, Skeletal Abnormalities, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CloxacilinDrug
2g/4 hours i.v., 5 days
CloxacillinDrug
2g/4h 14 days Standard therapy
LevofloxacinDrug
500 mg v.o./24h, 9 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days. Receives: Drug: Cloxacilin; Drug: Levofloxacin |
| Control | Active comparator | Cloxacillin 2g / 4 hrs iv 14 days Receives: Drug: Cloxacillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%.
Measured: 18 months
Secondary outcomes (2)
Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus.
Measured: 18 months
Reduce the transesophagic echocardiography
Increase efficiency in the management of patients with bacteremia due to MS S. aureus, reducing the number of echocardiographic evidence
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Not participants inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StaphylococcusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875263
- Sponsor's protocol ID
- FPS-COL-2013-06
- Other IDs
- 2013-000511-24
- Status last verified
- Aug 2015
- First submitted
- 7 Jun 2013
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Short-term Sequential Therapy Versus Intravenous Standard Treatment for Patients With Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.
- ClinicalTrials.gov ID
- NCT01875263
- Acronym / sponsor ID
- FPS-COL-2013-06
- Conditions
- Staphylococcus
- Keywords
- catheter-related bacteremia, SAMS, catheter related bacteremia, susceptible, aureus meticillin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not participants inclusion
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Jun 2013 (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.
Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established clinical and microbiological criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Cloxacilin, Drug: LevofloxacinCloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days. |
| Control | Active comparator | Drug: CloxacillinCloxacillin 2g / 4 hrs iv 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years with a minimum weight of 40 kg.
- Microbiological Isolation of S. aureus susceptible to meticillin.
- Start antibiotic treatment with drugs active against S. aureus within 72 hours from the onset of clinical manifestations.
- Women of childbearing potential, negative pregnancy test negative serum or urine or statement is not pregnant.
- Prescription prior treatment must be independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice.
Key exclusion criteria (19 listed)
- Polymicrobial bacteremia.
- Neutropenic patients.
- Patients addicted to intravenous drugs.
- Patients with malignancies with expected survival less than 6 months.
- Severe allergy to beta-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 |
|---|---|---|
| Cloxacilin2g/4 hours i.v., 5 days | Drug | Experimental |
| Cloxacillin2g/4h 14 days Standard therapy | Drug | Control |
| Levofloxacin500 mg v.o./24h, 9 days | Drug | Experimental |
Primary outcome
Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%.
Time frame: 18 months
2 secondary outcomes
Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus.
Time frame: 18 months
Reduce the transesophagic echocardiography
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Not participants inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cloxacilin, Cloxacillin and Levofloxacin in people with Staphylococcus, run by Fundación Pública Andaluza Progreso y Salud at 11 sites 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 5 inclusion and 19 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (reason given: Not participants inclusion). 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?
Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%. (time frame: 18 months). 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 7 Aug 2015; AzTrials last refreshed its copy on 6 Nov 2026.