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

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.

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Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

> 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Antibiotic Resistance Profiles

Time frame: Every three months within a 12 month period

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.

Secondary outcomes

Clinical Symptoms

Time frame: Every 3 months within a 12 month period

Secondary endpoint will be the change in clinical symptoms as assessed by the respiratory symptoms domain of the Cystic Fibrosis Questionnaire -Revised (CFQ-R),changes in pulmonary function Forced Exhaled Volume 1 second (FEV1) and change in frequency of hospitalizations or need for intravenous antibiotics.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

Gilead Sciences

Registry information

Official study title

Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2015
First posted: Mar 21, 2011
Registry last updated: Nov 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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