DiphtheriaNCT01890850
Study to Analyze the Risk Factors Associated With Pertussis/Whooping Cough Infection Among Infants
An observational study of Diphtheria and Acellular Pertussis, run by GlaxoSmithKline.
Trial summary
This study aims to estimate the risk factors associated with pertussis/whopping cough infection among infants less than one year of age in a United States (U.S.) commercially insured population. The study will utilize a large research data base associated with a geographically diverse U.S. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Diphtheria, Acellular Pertussis, Tetanus
- What is being tested?
- Retrospective database study using administrative claims data
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Infants less than one-year of age born between 2005 and 2010 in a U.S. commercially insured population contained within the optum propertity database
Who may be able to join
- Date of birth between July 1, 2005 and September 30, 2010.
- Enrollment in a commercial health plan within one month of birth.
- Known sex and geographic region.
- Infants will be included as a pertussis/whooping cough case if they meet the diagnosis criteria Infants not identified as a pertussis/whooping cough case are eligible for inclusion as a control.
Who cannot join
- Enrollment does not include medical and pharmacy coverage.
About this study
Official title: Risk Factors Associated With Pertussis Among Infants Less Than One-year of Age
This study aims to estimate the risk factors associated with pertussis/whopping cough infection among infants less than one year of age in a United States (U.S.) commercially insured population. The study will utilize a large research data base associated with a geographically diverse U.S. health plan not limited by one geographic area or disease outbreak to evaluate pertussis in infants between 2005 and 2010. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection will also be reported.
Read the detailed description
This study will utilize the OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans to estimate the measureable demographic, clinical and historical economic risk factors that may be associated with medically diagnosed pertussis/whooping cough infection among commercially insured infants less than one-year of age. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough will be stratified by the number of DTaP vaccinations received prior to infection.
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Being tested
- Retrospective database study using administrative claims data
- Keywords
- Risk factors, U.S. commercially insured population, Pertussis/whooping cough infection, Retrospective database study
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective database study using administrative claims dataOther
Data collection from OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans.
| Study group | Role | What they receive |
|---|---|---|
| Pertussis Group | Infants less than one year of age diagnosed with pertussis/whooping cough infection within 12 months from birth (first year of life, between July 1, 2005 and September 30, 2010). Receives: Other: Retrospective database study using administrative claims data | |
| Control Group | Infants with no evidence of pertussis/whooping cough during within 12 months from birth (first year of life, between July 1, 2005 and September 30, 2010). Receives: Other: Retrospective database study using administrative claims data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of claim identified pertussis/whooping cough
The endpoint(s) for the primary objective are the odds ratios associated with factors modelled in a logistic regression (conditional logit model) where the outcome is the diagnosis of pertussis/whooping cough. Demographic, economic and clinical risk factors available in the administrative claims database and potentially associated with pertussis/whooping cough infection will be estimated. Covariates will be determined based on clinical rationale and statistical significance.
Measured: Up to one year
Assessment of health care resource utilization
Health care resource utilization (e.g. ambulatory visits, emergency department visits, inpatient hospitalizations, length of stay) will be calculated for infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection.
Measured: Up to one year
Assessment of health care costs
Health care costs will be computed as the combined health plan and patient paid amounts in the post-index period. Costs will be calculated as a total costs, medical costs, pharmacy costs, ambulatory costs, emergency costs and other costs and split by those occurring prior to the index date and those in the follow-up period. Costs will be adjusted to 2012 U.S. dollar values using the Medical Care Consumer Price Index.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiphtheriaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optum, Carolyn Martin and Ami Buikema
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890850
- Sponsor's protocol ID
- 200158
- Status last verified
- Jul 2015
- First submitted
- 27 Jun 2013
- Last updated
- 22 Jul 2015
- Results posted
- No
Publications
Masseria C, Martin CK, Krishnarajah G, Becker LK, Buikema A, Tan TQ. Incidence and Burden of Pertussis Among Infants Less Than 1 Year of Age. Pediatr Infect Dis J. 2017 Mar;36(3):e54-e61. doi: 10.1097/INF.0000000000001440.
PubMed 27902648
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Associated With Pertussis Among Infants Less Than One-year of Age
- ClinicalTrials.gov ID
- NCT01890850
- Acronym / sponsor ID
- 200158
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Keywords
- Risk factors, U.S. commercially insured population, Pertussis/whooping cough infection, Retrospective database study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Optum, Carolyn Martin and Ami Buikema
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Jul 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.
This study aims to estimate the risk factors associated with pertussis/whopping cough infection among infants less than one year of age in a United States (U.S.) commercially insured population. The study will utilize a large research data base associated with a geographically diverse U.S. health plan not limited by one geographic area or disease outbreak to evaluate pertussis in infants between 2005 and 2010. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection will also be reported.
Detailed description
This study will utilize the OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans to estimate the measureable demographic, clinical and historical economic risk factors that may be associated with medically diagnosed pertussis/whooping cough infection among commercially insured infants less than one-year of age. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough will be stratified by the number of DTaP vaccinations received prior to infection.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pertussis Group | – | Other: Retrospective database study using administrative claims dataInfants less than one year of age diagnosed with pertussis/whooping cough infection within 12 months from birth (first year of life, between July 1, 2005 and September 30, 2010). |
| Control Group | – | Other: Retrospective database study using administrative claims dataInfants with no evidence of pertussis/whooping cough during within 12 months from birth (first year of life, between July 1, 2005 and September 30, 2010). |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants less than one-year of age born between 2005 and 2010 in a U.S. commercially insured population contained within the optum propertity database
Key inclusion criteria (4 listed)
- Date of birth between July 1, 2005 and September 30, 2010.
- Enrollment in a commercial health plan within one month of birth.
- Known sex and geographic region.
- Infants will be included as a pertussis/whooping cough case if they meet the diagnosis criteria Infants not identified as a pertussis/whooping cough case are eligible for inclusion as a control.
Key exclusion criteria (1 listed)
- Enrollment does not include medical and pharmacy coverage.
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 database study using administrative claims dataData collection from OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans. | Other | Control Group, Pertussis Group |
Primary outcome
Assessment of claim identified pertussis/whooping cough
Time frame: Up to one year
The endpoint(s) for the primary objective are the odds ratios associated with factors modelled in a logistic regression (conditional logit model) where the outcome is the diagnosis of pertussis/whooping cough. Demographic, economic and clinical risk factors available in the administrative claims database and potentially associated with pertussis/whooping cough infection will be estimated. Covariates will be determined based on clinical rationale and statistical significance.
Assessment of health care resource utilization
Time frame: Up to one year
Health care resource utilization (e.g. ambulatory visits, emergency department visits, inpatient hospitalizations, length of stay) will be calculated for infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection.
Assessment of health care costs
Time frame: Up to one year
Health care costs will be computed as the combined health plan and patient paid amounts in the post-index period. Costs will be calculated as a total costs, medical costs, pharmacy costs, ambulatory costs, emergency costs and other costs and split by those occurring prior to the index date and those in the follow-up period. Costs will be adjusted to 2012 U.S. dollar values using the Medical Care Consumer Price Index.
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 22 Jul 2015.
- Derived from this study: PubMed 27902648Masseria C, Martin CK, Krishnarajah G, Becker LK, Buikema A, Tan TQ. Incidence and Burden of Pertussis Among Infants Less Than 1 Year of Age. Pediatr Infect Dis J. 2017 Mar;36(3):e54-e61. doi: 10.1097/INF.0000000000001440.
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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 Diphtheria and Acellular Pertussis, 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 4 inclusion and 1 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 22 Jul 2015. 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?
Assessment of claim identified pertussis/whooping cough (time frame: Up to one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01890850, which also lists 1 linked publication.
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 22 Jul 2015.