Advertisement

Topics

Prophylactic Efficacy of Relenza Against Influenza A and B

2014-08-27 03:12:25 | BioPortfolio

Summary

In response to the European regulatory authorities, GSK is conducting a post-marketing observational study to assess the efficacy of Relenza when used as prophylaxis against influenza.

SPECIFIC AIMS

1. Determine the frequency of patients who received Relenza from October 2006 through April 2009, and among them the number who have no concurrent diagnosis of influenza, i.e., those receiving Relenza for prophylaxis, and among these the number who have a family member with a medical visit for influenza within three days preceding the above indentified patient's dispensing of Relenza. This is to determine the feasibility of conducting detailed analysis.

2. If analysis is feasible then tabulate the frequency of influenza-like-illness and respiratory outcomes in users of prophylactic Relenza and their family members and in family members of persons using Relenza for the treatment of influenza (i.e., index cases).

3. If analysis is feasible then estimate the direct effect of prophylactic Relenza on the occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of Relenza treatment of influenza on susceptible family members, and the total effect of Relenza (treatment plus prophylaxis).

METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like illness and respiratory outcomes in persons for whom some household members (index cases) have had a medical visit associated with a diagnosis of influenza. The exposed individuals to the index case will be categorized into one of four cohorts according to whether the exposed person received prophylactic Relenza or no antiviral treatment and by whether the index family member with a diagnosis of influenza received antiviral treatment.

Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing disease in susceptible family members, and the total effect of disease reduction when both index cases and susceptible family members are treated will be obtained from different comparisons between cohorts, as outlined below.

The research will cover the first three influenza seasons during which Relenza has been indicated for prophylactic use in the United States. These will be from October through April of 2006-2009.

Description

This analysis will use the i3 Ingenix proprietary National Health Information (NHI) database, containing claims and enrollment data back to 1993, with the opportunity to link patient and physician survey data to pharmacy and medical claims, and clinical laboratory results. These data are use for a wide range of pharmacoepidemiologic, healthcare utilization, and economic analyses. In addition to data derived from affiliated health plans, data from large, national employer groups are also stored in the database. The data undergo regular audits and quality control procedures. The accessible information includes demographics, pharmacy use, and all medical and facilities claims, which provide data on services, procedures, and their accompanying diagnoses. Underlying information is geographically diverse across the US, and is updated frequently. The insured population from which the database draws the data comprises approximately 4 percent of the US population. The data used for analysis is de-identified.

Study Cohorts From October 2006 through April 2009, we will count patients receiving prophylactic Relenza, defined as a dispensing of Relenza to a person who meets two criteria: (1) not having had a diagnosis of influenza associated with medical care on the day of dispensing or in the preceding three days, and (2) a household member has had a diagnosis of influenza associated with medical care on the day of the index dispensing or within the preceding three days. "Household members" will be defined operationally as persons within the RDM sharing a common family identifier and address.

We will assemble the study cohorts for the 3 influenza seasons running from October 2006 through April 2009. Cohort membership is based on the treatment an individual receives and the nature of household exposure.

Exclusion criteria include:

- Sex unknown

- Year of birth is missing or where the date of dispensing or service date preceded the year of birth

- Age at index date is less than 5 years

- Not enrolled in the health plan for 6 months prior to the study entry date

Observation begins for the prophylaxis and treated patients on the day following Relenza dispensing and for the non-prophylaxis and untreated patients on the third day following their medical visit, and continues for a total of 30 days.

Covariates For each individual we will identify age, sex, medical conditions requiring care in the six months preceding cohort entry from insurance claims for health services. Medical conditions requiring care will be defined at the 3-digit ICD9 diagnostic level.

Outcomes We will identify medical visits and hospitalizations with influenza-like illness and respiratory disease in the 30 days following cohort entry.

Analysis

Within categories of age of 5-14, 15-44, 45-64 and 65+ years, we will tabulate:

- the number of individuals in each of four cohorts (cohorts defined below)

- the number of medical visits for influenza-like illness and respiratory illness in the 30-day follow-up period

For each outcome we will estimate the following antiviral efficacy measures detailed in Halloran's analysis of clinical trials data [Halloran, 2007]. The first two effects below will be standardization to the age distribution of all persons receiving prophylactic Relenza;

1. Direct Effect of Relenza Prophylaxis: Risk in Cohort 1 is less than Risk in Cohort 3 Prophylaxis patient with untreated index case vs patient without prophylaxis with untreated index

2. Total Effect of Relenza Prophylaxis and Treatment: Risk in Cohort 2 is less than Risk in Cohort 3 Prophylaxis patient with treated index case vs. patient without prophylaxis with untreated index

We will calculate the following effect estimate with standardization to the age distribution of untreated persons.

3. Protective Effect of Relenza Prophylaxis on Susceptible: Risk in Cohort 2 is less than Risk in Cohort 4 Prophylaxis patient with treated index case vs. patient without prophylaxis with treated index

Using binomial regression and a linear risk model, we will obtain adjusted estimates for Direct Effect, Total Effect, and Protective Effect, defined as above, adjusted for age group, sex, and any diagnosis with a prevalence of at least 10 percent in the cohorts combined.

Study Design

Observational Model: Family-Based, Time Perspective: Retrospective

Conditions

Influenza, Human

Intervention

Receiving a prescription of Relenza for prophylaxis, No prophylaxis with Relenza

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:25-0400

Clinical Trials [1811 Associated Clinical Trials listed on BioPortfolio]

A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-Term Prophylaxis Against Pandemic Influenza: PIPET B

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as prophylaxis against pandemic influenza infection in patients who are prescribed a long term course in th...

A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.

This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in children during the flu season. Children who would benefit from influenza prophylaxis when infl...

Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients

The objective of this study is to deliver proof of concept that antifungal prophylaxis can reduce the incidence of Influenza Associated Aspergillosis (IAA) in ICU (intensive care unit) pat...

A Study of Tamiflu (Oseltamivir) for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients.

This 2 arm study will evaluate the efficacy and safety of Tamiflu in the seasonal prophylaxis of influenza in immunocompromised patients (as represented by transplant recipients). Transpla...

Education Bundle to Decrease Patient Refusal of VTE Prophylaxis

The investigators have recently developed a registry of missed doses of VTE prophylaxis that includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE prophy...

PubMed Articles [3404 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics of posaconazol in the prophylaxis and treatment of invasive fungal infection in immunocompromised children in a pediatric hospital.

Background There is no consensus on the optimal dosage use of posaconazole (PSC) for invasive fungal infection (IFI) in pediatric patients and normally it is adjusted with drug levels (DLs) ≥ 0.7 μ...

European guidelines on perioperative venous thromboembolism prophylaxis: Mechanical prophylaxis.

: Institutional protocols need to address the indications for pharmacological and mechanical thromboprophylaxis. The use of graduated compression stockings (GCS) and intermittent pneumatic compression...

Role of oral nystatin prophylaxis in cardiac surgery with prolongedextracorporeal circulation.

Duration >120 minutes of extracorporeal circulation (ECC) during cardiopulmonary bypass procedure was associated to an increased risk of candidemia in the intensive care unit (ICU). To evaluate oral ...

High Rates of Prescribing Antimicrobials for Prophylaxis in Children and Neonates: Results From the Antibiotic Resistance and Prescribing in European Children Point Prevalence Survey.

This study was conducted to assess the variation in prescription practices for systemic antimicrobial agents used for prophylaxis among pediatric patients hospitalized in 41 countries worldwide.

Exploring the impact of route of administration on medication acceptance in hospitalized patients: Implications for venous thromboembolism prevention.

Non-administration of venous thromboembolism (VTE) prophylaxis contributes to preventable patient harm. We hypothesized that non-administration would be more common for parenteral VTE prophylaxis than...

Medical and Biotech [MESH] Definitions

An RNA synthesis inhibitor that is used as an antiviral agent in the prophylaxis and treatment of influenza.

An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.

Use of antibiotics before, during, or after a diagnostic, therapeutic, or surgical procedure to prevent infectious complications.

A broad-spectrum antibiotic that is being used as prophylaxis against disseminated Mycobacterium avium complex infection in HIV-positive patients.

Administration of vaccines to stimulate the host's immune response. This includes any preparation intended for active immunological prophylaxis.

More From BioPortfolio on "Prophylactic Efficacy of Relenza Against Influenza A and B"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Influenza
Influenza or 'flu' is a respiratory illness associated with infection by influenza virus. Symptoms frequently include headache, fever, cough, sore throat, aching muscles and joints. There is a wide spectrum of severity of illness ranging from min...

Swine Flu - H1N1 influenza - H7N9
Swine flu is the common name given to a relatively new strain of influenza (flu) that caused a flu pandemic in 2009-2010. It is also referred to as H1N1 influenza (because it is the H1N1 strain of virus). The H1N1 flu virus will be one of the main vi...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial