BurnsPhase 3NCT00668044
Ciprofloxacin on Burned Patients
A Phase 3 study testing Ciprofloxacin (BAYO9867) in people with Burns and Bacterial Infections, run by Bayer at 7 sites in Italy.
Trial summary
This was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Bacterial Infections
- What is being tested?
- Ciprofloxacin (BAYO9867)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesItaly
- Study dates
- Nov 2002to Nov 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe burnt patients defined as burning of 20 to 60% of total body surface according to rule of nine, II deep degree and III degree according to Full-Thickness Burn model,
- Hospitalization for burning injury since at least 72h during hyper metabolic phase
- Active infections microbiological confirmed
- Signed informed consent
Who cannot join
- Pregnant or lactating female patients
- Previous history of tendinopathy
- Knowing syndrome of QTc prolongation
- Impairment renal function
- Hepatic insufficiency
- Convulsion
- Limited life expectancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Study site
Catania, 95126
Study site
Cesena, Forlì, 47023
Study site
Genova, 16132
Study site
Genova, 16149
Study site
Padova, 35128
Study site
Palermo, 90127
Study site
Roma, 00144
About this study
Official title: A Population Pharmacokinetics Study of Plasma Levels of Ciprofloxacin Following a Regimen of Repeated Dose I.V. Administration (400 mg TID) on Burn Patients
This was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead is over or under dosed.
- Conditions
- Burns, Bacterial Infections
- Being tested
- Ciprofloxacin (BAYO9867)
- Keywords
- Ciprofloxacin regimen in compromised patients, Ciprofloxacin, Burned patients
- Medical subject headings
- Burns, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin (BAYO9867)Drug
400 mg iv BID
Ciprofloxacin (BAYO9867)Drug
400 mg iv TID
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ciprofloxacin (BAYO9867) |
| Arm 2 | Experimental | Not described Receives: Drug: Ciprofloxacin (BAYO9867) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model
Measured: >72 h post injury, 48h and 120 h after treatment
Secondary outcomes (1)
Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio
Measured: >72 h post injury, 48h and 120 h after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startNov 2002
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668044
- Sponsor's protocol ID
- 10627
- Other IDs
- COB
- Status last verified
- Oct 2009
- First submitted
- 24 Apr 2008
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population Pharmacokinetics Study of Plasma Levels of Ciprofloxacin Following a Regimen of Repeated Dose I.V. Administration (400 mg TID) on Burn Patients
- ClinicalTrials.gov ID
- NCT00668044
- Acronym / sponsor ID
- 10627
- Conditions
- Burns, Bacterial Infections
- Keywords
- Ciprofloxacin regimen in compromised patients, Ciprofloxacin, Burned patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 28 Apr 2008 (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.
This was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead is over or under dosed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ciprofloxacin (BAYO9867) |
| Arm 2 | Experimental | Drug: Ciprofloxacin (BAYO9867) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate to severe burnt patients defined as burning of 20 to 60% of total body surface according to rule of nine, II deep degree and III degree according to Full-Thickness Burn model,
- Hospitalization for burning injury since at least 72h during hyper metabolic phase
- Active infections microbiological confirmed
- Signed informed consent
Key exclusion criteria (7 listed)
- Pregnant or lactating female patients
- Previous history of tendinopathy
- Knowing syndrome of QTc prolongation
- Impairment renal function
- Hepatic insufficiency
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 |
|---|---|---|
| Ciprofloxacin (BAYO9867)400 mg iv BID | Drug | Arm 1 |
| Ciprofloxacin (BAYO9867)400 mg iv TID | Drug | Arm 2 |
Primary outcome
Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model
Time frame: >72 h post injury, 48h and 120 h after treatment
1 secondary outcome
Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio
Time frame: >72 h post injury, 48h and 120 h after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
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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.
Bayer Study Director study director
Bayer
7 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 Ciprofloxacin (BAYO9867) in people with Burns and Bacterial Infections, run by Bayer at 7 sites in Italy.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model (time frame: >72 h post injury, 48h and 120 h after treatment). 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 27 Oct 2009.