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

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.

Study Overview

• Status: Completed
• Conditions: Tetanus; Diphtheria; Acellular Pertussis
• Intervention / Treatment: Other: Retrospective database study using administrative claims data

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 Type: Observational
• Enrollment (Actual): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to one year

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: Optum, Carolyn Martin and Ami Buikema

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): July 2, 2013

Study Record Updates

• Last Update Posted (Estimate): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Risk factors; U.S. commercially insured population; Pertussis/whooping cough infection; Retrospective database study
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Whooping Cough; Diphtheria
• Other Study ID Numbers: 200158