Infections, Respiratory TractNCT01353768
Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study
An observational study of Infections, Respiratory Tract, run by GlaxoSmithKline.
Trial summary
GSK is conducting a global retrospective chart review of patients treated with zanamivir as part of the Compassionate Use Program (CUP), in an effort to collect as much information as possible on the use of this investigational drug. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections, Respiratory Tract
- What is being tested?
- retrospective chart review
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Jan 2012
- 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: 350 patients previously treated with zanamivir aqueous solution as part of the CUP, at an estimated 100 sites in over 15 countries are targeted for participation. Medical information on safety and clinical outcomes from Tier 1 and Tier 2 patients will be collected within this retrospective chart review study.
Who may be able to join
- Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011 (Tier 1 cohort).
- Adult patients (Tier 2 cohort) that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011, treated at the same site as a Tier 1 patient.
Who cannot join
- Adult patients that received zanamivir aqueous solution at non-Tier 1 sites.
- Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program after 31 January 2011.
About this study
Official title: Medical Record Review and Data Abstraction for Pediatric, Adolescent and Pregnant Patients Treated With IV Zanamivir in the Relenza Compassionate Use Program
GSK is conducting a global retrospective chart review of patients treated with zanamivir as part of the Compassionate Use Program (CUP), in an effort to collect as much information as possible on the use of this investigational drug. The retrospective chart review is intended to gain a better understanding of the safety profile of investigational zanamivir and of clinical outcomes in the large number of patients treated outside of a clinical trial setting.
Read the detailed description
This is an observational, retrospective, multi-centre, cohort data collection study.
The CUP retrospective review study has been designed to collect safety and clinical outcome data from pediatric and pregnant patients (collectively referred to as the "Tier 1" cohort) treated globally within the CUP during the 2009/2010 pandemic (from May 2009) through 31 January 2011. The study will also attempt to collect data from other adult patients (referred to as the "Tier 2" cohort) who were treated at sites identified as having Tier 1 patients.
The treating physician at each site will receive a letter from the GSK medical director inviting him/her to participate in the retrospective chart review study. Physicians (or their delegates) who agree to participate will receive study-related documentation [including the protocol and case report form (CRF)] to orient the site to the study details and CRF. For the purposes of this study, the term "site" generally refers to a hospital where in-patient treatment was provided.
The retrospective chart review will be monitored via remote visits by telephone. The interviewer will be a Kendle associate assigned to the study who will not have direct access to the patient's source documents or medical records during conduct of the study. The physician/delegate will review the patient's chart and record data on a paper CRF. The CRF will be in the English language. Site personnel will mail completed CRFs to Kendle. Kendle will review the CRF for data quality, and conduct a remote monitoring visit via telephone to address any data queries, if required. No visits to participating sites are planned.
- Conditions
- Infections, Respiratory Tract
- Being tested
- retrospective chart review
- Keywords
- Influenza
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective chart reviewOther
retrospective chart review
| Study group | Role | What they receive |
|---|---|---|
| No treatment | zanamivir aqueous solution administered previously as part of the Compassionate Use Program Receives: Other: retrospective chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of patients who died
Measured: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Secondary outcomes (9)
Other anti-influenza therapies
Number of patients who received other anti-influenza therapies
Measured: for duration of influenza-related hospitalization, an expected average of 5 weeks
Chest X-ray abnormalities
Number of patients with abnormal findings
Measured: within 1-2 days of hospital admission or symptom onset
Resistance to zanamivir
Number of patients with documentation of resistance
Measured: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Other infections
Number of patients with diagnosis of other infections
Measured: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Complications of influenza
Number of patients with complications of influenza
Measured: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Ventilation/Oxygenation
Number of patients requiring ventilation support or supplemental oxygen
Measured: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Concomitant Medications
Number of patients receiving antibiotic/, antifungal/, orticosteroids, or inotropic medications
Measured: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Treatment emergent events
Number of patients experiencing a treatment emergent event
Measured: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Hemodialysis/Renal Replacement Therapy
Number of patients receiving hemodialysis or renal replacement therapy
Measured: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, Respiratory TractStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353768
- Sponsor's protocol ID
- 115008
- Status last verified
- Nov 2016
- First submitted
- 21 Apr 2011
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Record Review and Data Abstraction for Pediatric, Adolescent and Pregnant Patients Treated With IV Zanamivir in the Relenza Compassionate Use Program
- ClinicalTrials.gov ID
- NCT01353768
- Acronym / sponsor ID
- 115008
- Conditions
- Infections, Respiratory Tract
- Keywords
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 May 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.
GSK is conducting a global retrospective chart review of patients treated with zanamivir as part of the Compassionate Use Program (CUP), in an effort to collect as much information as possible on the use of this investigational drug. The retrospective chart review is intended to gain a better understanding of the safety profile of investigational zanamivir and of clinical outcomes in the large number of patients treated outside of a clinical trial setting.
Detailed description
This is an observational, retrospective, multi-centre, cohort data collection study.
The CUP retrospective review study has been designed to collect safety and clinical outcome data from pediatric and pregnant patients (collectively referred to as the "Tier 1" cohort) treated globally within the CUP during the 2009/2010 pandemic (from May 2009) through 31 January 2011. The study will also attempt to collect data from other adult patients (referred to as the "Tier 2" cohort) who were treated at sites identified as having Tier 1 patients.
The treating physician at each site will receive a letter from the GSK medical director inviting him/her to participate in the retrospective chart review study. Physicians (or their delegates) who agree to participate will receive study-related documentation [including the protocol and case report form (CRF)] to orient the site to the study details and CRF. For the purposes of this study, the term "site" generally refers to a hospital where in-patient treatment was provided.
The retrospective chart review will be monitored via remote visits by telephone. The interviewer will be a Kendle associate assigned to the study who will not have direct access to the patient's source documents or medical records during conduct of the study. The physician/delegate will review the patient's chart and record data on a paper CRF. The CRF will be in the English language. Site personnel will mail completed CRFs to Kendle. Kendle will review the CRF for data quality, and conduct a remote monitoring visit via telephone to address any data queries, if required. No visits to participating sites are planned.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: retrospective chart reviewzanamivir aqueous solution administered previously as part of the Compassionate Use Program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 350 patients previously treated with zanamivir aqueous solution as part of the CUP, at an estimated 100 sites in over 15 countries are targeted for participation. Medical information on safety and clinical outcomes from Tier 1 and Tier 2 patients will be collected within this retrospective chart review study.
Key inclusion criteria (2 listed)
- Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011 (Tier 1 cohort).
- Adult patients (Tier 2 cohort) that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011, treated at the same site as a Tier 1 patient.
Key exclusion criteria (2 listed)
- Adult patients that received zanamivir aqueous solution at non-Tier 1 sites.
- Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program after 31 January 2011.
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 |
|---|---|---|
| retrospective chart reviewretrospective chart review | Other | No treatment |
Primary outcome
Mortality
Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Number of patients who died
9 secondary outcomes
Other anti-influenza therapies
Time frame: for duration of influenza-related hospitalization, an expected average of 5 weeks
Chest X-ray abnormalities
Time frame: within 1-2 days of hospital admission or symptom onset
Resistance to zanamivir
Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Other infections
Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Complications of influenza
Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Ventilation/Oxygenation
Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Concomitant Medications
Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Treatment emergent events
Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
Hemodialysis/Renal Replacement Therapy
Time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks
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 23 Nov 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Respiratory Tract, run by GlaxoSmithKline.
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 2 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Mortality (time frame: for duration of influenza-related hospitalization, an expected average duration of 5 weeks). 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 23 Nov 2016; AzTrials last refreshed its copy on 29 Oct 2026.