Study to Analyze the Risk Factors Associated With Pertussis/Whooping Cough Infection Among Infants

This study has been completed.
Sponsor:
Collaborator:
Optum, Carolyn Martin and Ami Buikema
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01890850
First received: June 27, 2013
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Diphtheria
Acellular Pertussis
Tetanus
Other: Retrospective database study using administrative claims data

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Risk Factors Associated With Pertussis Among Infants Less Than One-year of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Assessment of claim identified pertussis/whooping cough [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1
Study Start Date: May 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
Other: Retrospective database study using administrative claims data
Data collection from OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans.
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).
Other: Retrospective database study using administrative claims data
Data collection from OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans.

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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• Enrollment does not include medical and pharmacy coverage.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890850

Sponsors and Collaborators
GlaxoSmithKline
Optum, Carolyn Martin and Ami Buikema
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01890850     History of Changes
Other Study ID Numbers: 200158
Study First Received: June 27, 2013
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
U.S. commercially insured population
Risk factors
Pertussis/whooping cough infection
Retrospective database study

Additional relevant MeSH terms:
Whooping Cough
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 23, 2014