A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies

NCT01319253 | Completed

• 1 other identifier: HOWEN-ANDER-001
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.

Conditions

Cystic Fibrosis; Pseudomonas Aeruginosa

Keywords

Cystic Fibrosis; Pseudomonas aeruginosa

Outcome Measures

Primary Outcomes (1)

• Antibiotic Resistance Profiles

  The primary endpoint will be a change in the microbial resistance profile of pseudomonas aeruginosa (PA)isolates, change in PA sputum density, minimum inhibitory concentration of aztreonam and tobramycin for PA and the appearance or disappearance of other pathogens.

  Every three months within a 12 month period

Secondary Outcomes (1)

• Clinical Symptoms

  Every 3 months within a 12 month period

Study Arms (3)

Cayston Only Cohort

This cohort will be on a previously established medication regiment of Cayston inhaled antibiotic alternating regimen every other month.

Tobi Only Cohort

This Cohort will be on a previously established medication regiment that includes Tobi inhaled antibiotic regimen alternating every other month.

Cayston and Tobi Cohort

This Cohort will be on a previously established medication regiment that includes Cayston and Tobi inhaled antibiotic alternating every other month

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• \> or = to 6 years of age
• Documentation of Cf diagnosis
• History of PA present in sputum, on a least one occasion, during the 12 months prior to Visit 1.
• Currently on inhaled antibiotic regiment
• Must be able to provide written informed consent or assent prior to any study related procedures
• Ability to expectorate sputum
• Ability ro perform reproducible pulmonary function test

You may not qualify if:

• Administration of any IV or oral antipseudomonal antibiotic within 28 days prior to Visit 1
• Any serious or active medical or psychiatric illness, which in the opinion of the investigator, woud interfere with participant treatment, assessment, or compliance with the protocol
• Current enrollment in an interventional clinical trial

Sponsors & Collaborators

• Indiana University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Michelle S Howenstine, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Gregory Anderson, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 21, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

US (1)