InfectionNCT01304459
Vancomycin Serum Concentrations in Pediatric Oncology Patients Under Intensive Care
An observational study of Infection, run by Grupo de Apoio ao Adolescente e a Crianca com Cancer at 1 site in Brazil.
Trial summary
Observational protocol to analyse routine vancomycin serum levels of patients under intensive care and to obtain percentage of patients that achieve therapeutic values. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric oncology patients on intensive care unit for treatment of infections.
Who may be able to join
- Hospitalized pediatric oncology patients
- Patients under vancomycin treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Grupo de Apoio ao Adolescente e à Criança com Câncer
São Paulo, São Paulo, 04023-062
About this study
Observational protocol to analyse routine vancomycin serum levels of patients under intensive care and to obtain percentage of patients that achieve therapeutic values.
- Conditions
- Infection
- Medical subject headings
- Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Apoio ao Adolescente e a Crianca com Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GLAUCIA TORIBIO FINOTI SEIXAS, Grupo de Apoio ao Adolescente e a Crianca com Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304459
- Sponsor's protocol ID
- UTI/IOP 01/11
- Other IDs
- 1913/10
- Status last verified
- Mar 2012
- First submitted
- 24 Feb 2011
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin Serum Concentrations in Pediatric Oncology Patients Under Intensive Care
- ClinicalTrials.gov ID
- NCT01304459
- Acronym / sponsor ID
- UTI/IOP 01/11
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Grupo de Apoio ao Adolescente e a Crianca com CancerUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 25 Feb 2011 (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.
Observational protocol to analyse routine vancomycin serum levels of patients under intensive care and to obtain percentage of patients that achieve therapeutic values.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric oncology patients on intensive care unit for treatment of infections.
Key inclusion criteria (2 listed)
- Hospitalized pediatric oncology patients
- Patients under vancomycin treatment
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Grupo de Apoio ao Adolescente e a Crianca com Cancer at 1 site in Brazil.
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 0 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: status not confirmed, as of the sponsor's last update on 23 Mar 2012. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Glaucia T Finoti, MD (55-11-5080-8575, glaucia.finoti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 23 Mar 2012.