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

NCT01890850 | Completed

• 1 other identifier: 200158
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Diphtheria; Acellular Pertussis; Tetanus

Keywords

Risk factors; U.S. commercially insured population; Pertussis/whooping cough infection; Retrospective database study

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Retrospective database study using administrative claims data OTHER

Data collection from OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans.

Control Group; Pertussis Group

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Enrollment does not include medical and pharmacy coverage.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Optum, Carolyn Martin and Ami Buikema: collaborator

Related Publications (1)

• 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.

  PMID: 27902648 DERIVED

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 22, 2015

Record last verified: 2015-07