Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided EndocarditisNCT01219114
Safety and Efficacy Study of CUBICIN (Daptomycin) Under Conditions of Actual Use
An observational study of Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis, run by AstraZeneca at 5 sites in Philippines.
Trial summary
The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions of actual use in patients who are diagnosed with complicated Skin and Skin Structure infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are prescribed CUBICIN by their physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis
- How many people
- 200 participants
- Where
- 5 sitesPhilippines
- Study dates
- Oct 2010to Nov 2013
- Phase
- Observational
- 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
Study population: several private and government tertiary hospitals
Who may be able to join
- Diagnosis of cSSSI known or suspected to be due to gram-positive bacteria
- Diagnosis of right-sided endocarditis with one or more positive culture for S. aureus within two days prior to initiation of medication
- Prescribed daptomycin by patient's attending physician
Who cannot join
- Known allergic or serious adverse reaction to daptomycin
- Patients with pneumonia
- Patients with baseline CPK values >1000 U/L or 5x ULN
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Philippines5 sites
Research Site
Davao City, Davao Region
Research Site
Iloilo City, Iloilo
Research Site
Lipa City, Batangas
Research Site
Pasig, National Capital Region
Research Site
Quezon City, National Capital Region
About this study
Official title: A Descriptive Study of the Efficacy and Safety of CUBICIN (Daptomycin) Under Conditions of Actual Use in the Philippines
The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions of actual use in patients who are diagnosed with complicated Skin and Skin Structure infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are prescribed CUBICIN by their physician.
- Conditions
- Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis
- Keywords
- Daptomycin, endocarditis, complicated skin and skin structure infection
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events observed during the treatment duration
Measured: Ranges from during treatment and up to 14 days after last administration of daptomycin (follow up)
Clinical Response determined by cure rate
Measured: Ranges from during treatment and up to 14 days after last administration of daptomycin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013 (estimated)
- Study completionNov 2013 (estimated)
Why it stopped: Inability to recruit patients within the specified time period. No patients have been enrolled in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided EndocarditisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milagros Tan, MD, Study director, AstraZeneca PhilippinesEmmanuel Arca, MD, Study chair, AstraZeneca Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219114
- Sponsor's protocol ID
- NIS-IPH-DUM-2010/1
- Status last verified
- Sep 2011
- First submitted
- 10 Oct 2010
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study of the Efficacy and Safety of CUBICIN (Daptomycin) Under Conditions of Actual Use in the Philippines
- ClinicalTrials.gov ID
- NCT01219114
- Acronym / sponsor ID
- NIS-IPH-DUM-2010/1
- Conditions
- Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis
- Keywords
- Daptomycin, endocarditis, complicated skin and skin structure infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Inability to recruit patients within the specified time period. No patients have been enrolled in the study.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 13 Oct 2010 (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 monitor the safety and efficacy of CUBICIN under conditions of actual use in patients who are diagnosed with complicated Skin and Skin Structure infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are prescribed CUBICIN by their physician.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- several private and government tertiary hospitals
Key inclusion criteria (3 listed)
- Diagnosis of cSSSI known or suspected to be due to gram-positive bacteria
- Diagnosis of right-sided endocarditis with one or more positive culture for S. aureus within two days prior to initiation of medication
- Prescribed daptomycin by patient's attending physician
Key exclusion criteria (3 listed)
- Known allergic or serious adverse reaction to daptomycin
- Patients with pneumonia
- Patients with baseline CPK values >1000 U/L or 5x ULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse events observed during the treatment duration
Time frame: Ranges from during treatment and up to 14 days after last administration of daptomycin (follow up)
Clinical Response determined by cure rate
Time frame: Ranges from during treatment and up to 14 days after last administration of daptomycin
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
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.
Milagros Tan, MD study director
AstraZeneca Philippines
Emmanuel Arca, MD study chair
AstraZeneca Philippines
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis, run by AstraZeneca at 5 sites in Philippines.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Philippines. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Adverse events observed during the treatment duration (time frame: Ranges from during treatment and up to 14 days after last administration of daptomycin (follow up)). The study lists 2 primary outcomes in all. 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 28 Sep 2011.