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OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis (OPTIMIZE)

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
azithromycin
placebo
Tobramycin solution for inhalation
Sponsored by
Bonnie Ramsey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic fibrosis (CF), Azithromycin, Tobramycin solution for inhalation (TIS), Pseudomonas aeruginosa (Pa), Early Pseudomonas aeruginosa infection, Pulmonary exacerbation, Standardized anti-pseudomonal therapy

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 6 months to ≤ 18 years
  • Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype or positive CF Newborn Screening result for immunoreactive trypsinogen (IRT) IRT/DNA or IRT/IRT and one or more of the following criteria:
  • sweat chloride ≥ 60 milliequivalent (mEq)/liter by quantitative by pilocarpine iontophoresis test (QPIT)
  • two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
  • Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than - 5 mV)
  • Documented new positive oropharyngeal, sputum or lower respiratory tract culture for Pa within 30 days of the Baseline Visit (Visit 1), defined as: a) first lifetime documented Pa positive culture; or b) Pa recovered after at least a two-year history of Pa negative respiratory cultures (≥ 1 culture/ year)
  • Clinically stable with no evidence of any significant respiratory symptoms at the Baseline Visit that would require administration of intravenous anti- pseudomonal antibiotics, oxygen supplementation, and/or hospitalization as determined by the study physician
  • Written informed consent obtained from participant or participant's legal representative (and assent when applicable) and ability for participant to comply with the requirements of the study

Exclusion Criteria:

  • Macrolide antibiotic use within 30 days of the Baseline Visit
  • Initiation of current course of treatment with TIS >14 days prior to Baseline Visit
  • Weight <6.0 kg at the Baseline Visit
  • History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside
  • History of azithromycin hypersensitivity or adverse reaction to azithromycin or allergy to macrolide antibiotics
  • History of positive respiratory culture for Non-tuberculous mycobacteria (NTM) or Burkholderia cepacia complex within 2 years of the Baseline Visit
  • History of unresolved, abnormal renal function (defined as serum creatinine greater than 1.5 times the upper limit of normal for age).
  • History of unresolved, abnormal liver function tests (defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 4 times the upper limit of normal range) or history of portal hypertension
  • History of unresolved, abnormal neutropenia (ANC ≤ 1000)
  • Abnormal ECG test at the Baseline Visit defined as a QT interval corrected (QTc) (B) of ≥460 msec or history of ventricular arrhythmia
  • History of abnormal hearing sensitivity defined as hearing threshold levels >25 dB HL (decibels Hearing Level) for visual reinforcement audiometry (VRA) at any frequency (500-4000Hz) or >20 Decibels Hearing Level (dBHL) for play or standard audiometry at any two frequencies (500-8000Hz) in either ear, not associated with middle ear disease (including infection) or a flat (Type B) tympanogram
  • New initiation of chronic therapy (greater than 21 days) with drugs known to prolong QT interval (refer to Appendix III) within 30 days prior to the Baseline Visit or coadministration of nelfinavir or oral anticoagulants
  • Positive serum or urine pregnancy test at the Baseline Visit (to be performed on all females of child-bearing potential) or for females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception during participation in the study
  • Administration of any investigational drug within 30 days prior to the Baseline Visit
  • Presence of a condition or abnormality (e.g., pre-existing heart disease) that in the opinion of the site investigator would compromise the safety of the participant or the quality of the data

Sites / Locations

  • CFF Affiliate Program Providence Medical Center
  • CFF Care Center Arizona Health Science Center
  • CFF Care Center & Pediatric Program Arkansas Children's Hospital
  • Childrens Hospital Los Angeles
  • CFF Care Center & Pediatric Program Stanford University
  • CFF Care Center & Pediatric Program Children's Hospital Colorado
  • CFF Care Center & Pediatric Program Yale University
  • CFF Care Center & Pediatric Program Nemours Children's Clinic - Jacksonville
  • CFF Care Center & Pediatric Program All Children's Hospital
  • CFF Care Center & Pediatric Program Emory University
  • CFF Affiliate Program Children's Healthcare of Atlanta
  • CFF Care Center St. Luke's CF Clinic
  • CFF Care Center & Pediatric Program Ann & Robert H. Lurie Children's Hospital of Chicago
  • CFF Care Center & Pediatric Program Riley Hospital for Children
  • CFF Care Center & Pediatric Program University of Iowa
  • CFF Care Center & Pediatric Program Maine Medical Center
  • CFF Care Center & Pediatric Program Children's Hospital Boston
  • CFF Care Center & Pediatric Program University of Michigan
  • CFF Care Center & Pediatric Program Children's Hospital of Michigan
  • CFF Care Center The Children's Mercy Hospital
  • CFF Care Center & Pediatric Program Cardinal Glennon Children's Hospital/Saint Louis University
  • CFF Care Center & Pediatric Program St. Louis Children's Hospital
  • CFF Care Center & Pediatric Program University of Nebraska Medical Center
  • CFF Care Center & Pediatric Program Monmouth Medical Center
  • CFF Care Center & Pediatric Program Columbia University
  • CFF Care Center & Pediatric Program SUNY Upstate Medical University
  • CFF Care Center New York Medical College
  • CFF Care Center & Pediatric Program University of North Carolina at Chapel Hill
  • CFF Care Center & Pediatric Program Akron Children's Hospital
  • CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center
  • CFF Care Center & Pediatric Program Rainbow Babies and Children's Hospital
  • CFF Care Center & Pediatric Program Nationwide Children's Hospital
  • CFF Care Center & Pediatric Program The Children's Medical Center
  • CFF Care Center & Pediatric Program Oregon Health & Sciences University
  • CFF Care Center & Pediatric Program Hershey Medical Center
  • CFF Care Center & Pediatric Program Children's Hospital of Pittsburgh
  • CFF Care Center & Pediatric Program Sanford USD Medical Center
  • CFF Care Center & Pediatric Program University of Tennessee
  • CFF Care Center & Pediatric Program Dell Children's Medical Center of Central Texas
  • University of Utah
  • CFF Care Center & Pediatric Program Children's Hospital of the King's Daughters
  • CFF Care Center Medical College of Virginia
  • CFF Care Center & Pediatric Program Seattle Children's Hospital
  • CFF Care Center & Pediatric Program University of Wisconsin
  • CFF Care Center & Pediatric Program Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

azithromycin and TIS

placebo and TIS

Arm Description

azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months

placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months

Outcomes

Primary Outcome Measures

Time to a Protocol-defined Pulmonary Exacerbation
Time to a protocol-defined pulmonary exacerbation requiring oral, inhaled, or intravenous antibiotics, using a prespecified definition available in the study protocol.

Secondary Outcome Measures

Time to Pseudomonas Aeruginosa (Pa) Recurrence
Time to Pseudomonas aeruginosa (Pa) recurrence after the first quarter of treatment
Adverse Events (AEs) and Serious Adverse Events (SAEs)
The number and percentage of participants with at least one event over the 18-month study period.
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Rate is defined as the number of events per participant follow-up month.

Full Information

First Posted
February 1, 2014
Last Updated
September 12, 2019
Sponsor
Bonnie Ramsey
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02054156
Brief Title
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
Acronym
OPTIMIZE
Official Title
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bonnie Ramsey
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.
Detailed Description
Cystic fibrosis (CF) lung disease begins in the first few months of life and follows a course of recurrent lower airway bacterial infection and inflammation and progression of disease over years and decades at a variable pace. With the development of chronic lung infection, obstructive disease progressively worsens, ultimately leading to respiratory failure. Pseudomonas aeruginosa (Pa) is the most important pathogen infecting the CF lower airways, and its acquisition early in life is associated with a pro-inflammatory effect, lower lung function, poor nutritional outcomes, and decreased survival. Pseudomonas aeruginosa (Pa) infection of the cystic fibrosis (CF) airway typically proceeds from early infection to chronic infection. Although some studies have shown that a minority of individuals with CF spontaneously clear early Pseudomonas aeruginosa (Pa) infection, data from multiple studies suggest that antibiotics are superior to no treatment in clearing Pseudomonas aeruginosa (Pa) from respiratory cultures. Understanding the transition period from early to chronic Pseudomonas aeruginosa (Pa) infection is thus of critical importance in identifying strategies to prevent this progression. The study will assess the clinical and microbiologic efficacy and safety of azithromycin given three times weekly in combination with standardized tobramycin solution for inhalation (TIS) therapy among children with early Pseudomonas aeruginosa (Pa). TIS therapy is defined as an initial eradication treatment with 1-2 courses of 28 days TIS and subsequent 28 day treatments only at times a quarterly respiratory culture is positive for Pseudomonas aeruginosa (Pa). Eligible participants will be randomized within one month of their Pseudomonas aeruginosa (Pa) positive culture to receive one of the following two treatment strategies for 18 months: (1) oral placebo in addition to standardized TIS therapy, or (2) oral azithromycin in addition to standardized TIS therapy. At the first study visit, participants will undergo a physical examination and a review of their medical history. Lung function will be measured via spirometry (in children greater than four years of age who are able to perform spirometry), electrocardiogram (ECG) testing will be conducted, and hearing ability will be measured via audiometry. Blood will be drawn for laboratory tests and a specimen will be obtained for a respiratory culture before randomization and study drug dispensing occurs. Subsequent study visits will take place at Day 21, Weeks 13, 26, 39, 52, 65, and 78. At each visit, participants will undergo a physical examination, a spirometry test (as appropriate), a respiratory specimen for Pseudomonas aeruginosa (Pa) culture will be collected and study drug will be dispensed (except at Week 78). Participants will complete self-report or parent-completed respiratory symptom questionnaires and signs and symptoms evaluations will be performed at all visits. Repeat hearing and laboratory tests will be performed at Weeks 39 and 78 and ECG testing will be repeated at Day 21 and Week 78. Participants will be required to maintain a medication diary throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic fibrosis (CF), Azithromycin, Tobramycin solution for inhalation (TIS), Pseudomonas aeruginosa (Pa), Early Pseudomonas aeruginosa infection, Pulmonary exacerbation, Standardized anti-pseudomonal therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
azithromycin and TIS
Arm Type
Active Comparator
Arm Description
azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
Arm Title
placebo and TIS
Arm Type
Placebo Comparator
Arm Description
placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
Intervention Type
Drug
Intervention Name(s)
azithromycin
Intervention Description
3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Intervention Type
Drug
Intervention Name(s)
Tobramycin solution for inhalation
Other Intervention Name(s)
TIS
Intervention Description
300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
Primary Outcome Measure Information:
Title
Time to a Protocol-defined Pulmonary Exacerbation
Description
Time to a protocol-defined pulmonary exacerbation requiring oral, inhaled, or intravenous antibiotics, using a prespecified definition available in the study protocol.
Time Frame
Over the 18-month study period
Secondary Outcome Measure Information:
Title
Time to Pseudomonas Aeruginosa (Pa) Recurrence
Description
Time to Pseudomonas aeruginosa (Pa) recurrence after the first quarter of treatment
Time Frame
Over the 18-month study period
Title
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
The number and percentage of participants with at least one event over the 18-month study period.
Time Frame
Over the 18-month study period
Title
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Rate is defined as the number of events per participant follow-up month.
Time Frame
Over the 18-month study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 6 months to ≤ 18 years Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype or positive CF Newborn Screening result for immunoreactive trypsinogen (IRT) IRT/DNA or IRT/IRT and one or more of the following criteria: sweat chloride ≥ 60 milliequivalent (mEq)/liter by quantitative by pilocarpine iontophoresis test (QPIT) two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than - 5 mV) Documented new positive oropharyngeal, sputum or lower respiratory tract culture for Pa within 30 days of the Baseline Visit (Visit 1), defined as: a) first lifetime documented Pa positive culture; or b) Pa recovered after at least a two-year history of Pa negative respiratory cultures (≥ 1 culture/ year) Clinically stable with no evidence of any significant respiratory symptoms at the Baseline Visit that would require administration of intravenous anti- pseudomonal antibiotics, oxygen supplementation, and/or hospitalization as determined by the study physician Written informed consent obtained from participant or participant's legal representative (and assent when applicable) and ability for participant to comply with the requirements of the study Exclusion Criteria: Macrolide antibiotic use within 30 days of the Baseline Visit Initiation of current course of treatment with TIS >14 days prior to Baseline Visit Weight <6.0 kg at the Baseline Visit History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside History of azithromycin hypersensitivity or adverse reaction to azithromycin or allergy to macrolide antibiotics History of positive respiratory culture for Non-tuberculous mycobacteria (NTM) or Burkholderia cepacia complex within 2 years of the Baseline Visit History of unresolved, abnormal renal function (defined as serum creatinine greater than 1.5 times the upper limit of normal for age). History of unresolved, abnormal liver function tests (defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 4 times the upper limit of normal range) or history of portal hypertension History of unresolved, abnormal neutropenia (ANC ≤ 1000) Abnormal ECG test at the Baseline Visit defined as a QT interval corrected (QTc) (B) of ≥460 msec or history of ventricular arrhythmia History of abnormal hearing sensitivity defined as hearing threshold levels >25 dB HL (decibels Hearing Level) for visual reinforcement audiometry (VRA) at any frequency (500-4000Hz) or >20 Decibels Hearing Level (dBHL) for play or standard audiometry at any two frequencies (500-8000Hz) in either ear, not associated with middle ear disease (including infection) or a flat (Type B) tympanogram New initiation of chronic therapy (greater than 21 days) with drugs known to prolong QT interval (refer to Appendix III) within 30 days prior to the Baseline Visit or coadministration of nelfinavir or oral anticoagulants Positive serum or urine pregnancy test at the Baseline Visit (to be performed on all females of child-bearing potential) or for females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception during participation in the study Administration of any investigational drug within 30 days prior to the Baseline Visit Presence of a condition or abnormality (e.g., pre-existing heart disease) that in the opinion of the site investigator would compromise the safety of the participant or the quality of the data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie Ramsey, MD
Organizational Affiliation
Seattle Children's Center for Clinical and Translational Research, CF Therapeutics Development Network Clinical Coordinating Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole Hamblett, PhD
Organizational Affiliation
Seattle Children's Core for Biomedical Statistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
CFF Affiliate Program Providence Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99519-6604
Country
United States
Facility Name
CFF Care Center Arizona Health Science Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
CFF Care Center & Pediatric Program Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
CFF Care Center & Pediatric Program Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
CFF Care Center & Pediatric Program Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
CFF Care Center & Pediatric Program Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
CFF Care Center & Pediatric Program Nemours Children's Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
CFF Care Center & Pediatric Program All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
CFF Care Center & Pediatric Program Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Facility Name
CFF Affiliate Program Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
CFF Care Center St. Luke's CF Clinic
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
CFF Care Center & Pediatric Program Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2605
Country
United States
Facility Name
CFF Care Center & Pediatric Program Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5271
Country
United States
Facility Name
CFF Care Center & Pediatric Program University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
CFF Care Center & Pediatric Program Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
CFF Care Center & Pediatric Program Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
CFF Care Center & Pediatric Program University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5212
Country
United States
Facility Name
CFF Care Center & Pediatric Program Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
CFF Care Center The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
CFF Care Center & Pediatric Program Cardinal Glennon Children's Hospital/Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
CFF Care Center & Pediatric Program St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CFF Care Center & Pediatric Program University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
CFF Care Center & Pediatric Program Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
CFF Care Center & Pediatric Program Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
CFF Care Center & Pediatric Program SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CFF Care Center New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
CFF Care Center & Pediatric Program University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
CFF Care Center & Pediatric Program Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
CFF Care Center & Pediatric Program Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
CFF Care Center & Pediatric Program Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
CFF Care Center & Pediatric Program The Children's Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
CFF Care Center & Pediatric Program Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
CFF Care Center & Pediatric Program Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
CFF Care Center & Pediatric Program Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
CFF Care Center & Pediatric Program Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Facility Name
CFF Care Center & Pediatric Program University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
CFF Care Center & Pediatric Program Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
CFF Care Center & Pediatric Program Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
CFF Care Center Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
CFF Care Center & Pediatric Program Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98145
Country
United States
Facility Name
CFF Care Center & Pediatric Program University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
CFF Care Center & Pediatric Program Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29890086
Citation
Mayer-Hamblett N, Retsch-Bogart G, Kloster M, Accurso F, Rosenfeld M, Albers G, Black P, Brown P, Cairns A, Davis SD, Graff GR, Kerby GS, Orenstein D, Buckingham R, Ramsey BW; OPTIMIZE Study Group. Azithromycin for Early Pseudomonas Infection in Cystic Fibrosis. The OPTIMIZE Randomized Trial. Am J Respir Crit Care Med. 2018 Nov 1;198(9):1177-1187. doi: 10.1164/rccm.201802-0215OC. Erratum In: Am J Respir Crit Care Med. 2019 Mar 15;199(6):809.
Results Reference
derived

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OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis

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