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Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF) (STAR-Too)

This study has been terminated.
(Interim review showed a statistically significant treatment effect and the DMC recommended that the study be stopped with ongoing follow-up of enrolled subjects)
Sponsor:
Collaborators:
CF Therapeutics Development Network Coordinating Center
Seattle Children's Hospital
Washington University School of Medicine
University of Washington
University of Colorado, Denver
Baylor College of Medicine
University of Alabama at Birmingham
Cook Children's Medical Center
University of Michigan
University of Florida
University of Texas Southwestern Medical Center
Children's Hospital Medical Center, Cincinnati
St. Louis Children's Hospital
Information provided by (Responsible Party):
Marianne Muhlebach, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01349192
First received: May 4, 2011
Last updated: April 5, 2017
Last verified: April 2017
Results First Received: November 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Investigator;   Primary Purpose: Treatment
Conditions: Cystic Fibrosis
Methicillin-resistant Staphylococcus Aureus
Interventions: Drug: Rifampin
Drug: Trimethoprim/Sulfamethoxazole
Drug: Minocycline
Drug: Mupirocin
Drug: chlorhexidine gluconate oral rinse
Drug: 2% Chlorhexidine solution wipes
Behavioral: Environmental Decontamination

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted from April 1, 2011 to September 2014 at 14 CF Foundation accredited care centers in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment

Oral antibiotics:

  1. Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
  2. Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.

Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.

Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.

Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.

Topical:

Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.

Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.

Environmental disinfection of high use areas

Observational Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.

Participant Flow:   Overall Study
    Treatment   Observational
STARTED   24   23 
Evaluable for Primary Endpoint   22   19 
Withdrawals   3   6 
COMPLETED   21   17 
NOT COMPLETED   3   6 
Protocol Violation                0                1 
Withdrawal by Subject                0                2 
Lost to Follow-up                1                3 
Failure to adhere to Protocol                2                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment

Oral antibiotics:

  1. Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
  2. Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.

Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.

Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.

Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.

Topical:

Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.

Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.

Environmental disinfection of high use areas

Observational Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
Total Total of all reporting groups

Baseline Measures
   Treatment   Observational   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   21   45 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 24   21   45 
   12.3  (6.6)   10.5  (5.5)   11.5  (6.1) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age Category       
Participants Analyzed 
[Units: Participants]
 24   21   45 
>=4 and <12 years      13  54.2%      15  71.4%      28  62.2% 
>=12 and <18 years      6  25.0%      5  23.8%      11  24.4% 
>18 years      5  20.8%      1   4.8%      6  13.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 24   21   45 
Female      10  41.7%      10  47.6%      20  44.4% 
Male      14  58.3%      11  52.4%      25  55.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity Combined       
Participants Analyzed 
[Units: Participants]
 24   21   45 
Caucasian      19  79.2%      17  81.0%      36  80.0% 
Hispanic      3  12.5%      2   9.5%      5  11.1% 
African-American      1   4.2%      1   4.8%      2   4.4% 
Other      1   4.2%      1   4.8%      2   4.4% 
CF Genotype 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 24   21   45 
Delta F508 Homozygous      6  25.0%      12  57.1%      18  40.0% 
Delta F508 Heterozygous      14  58.3%      7  33.3%      21  46.7% 
Other      4  16.7%      2   9.5%      6  13.3% 
Unidentified      0   0.0%      0   0.0%      0   0.0% 
FEV1 Percent of Predicted [1] [2] 
[Units: Percent]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 20   17   37 
   98.5  (21.6)   101.2  (11.8)   99.8  (17.6) 
[1] Percent of predicted forced expiratory volume in one second, based on Wang and Hankinson reference equations.
[2] Lung function was assessed for the subset of participants that were ≥ 6 years old and able to reliably perform spirometry.
FEV1 Percent of Predicted Category [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 20   17   37 
>=30% to <=50%      1   5.0%      0   0.0%      1   2.7% 
>50% to <=75%      1   5.0%      0   0.0%      1   2.7% 
>75% to <=100%      7  35.0%      5  29.4%      12  32.4% 
>100%      11  55.0%      12  70.6%      23  62.2% 
[1] Lung function was assessed for the subset of participants that were ≥ 6 years old and able to reliably perform spirometry.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   MRSA Culture Status   [ Time Frame: Day 28 ]

2.  Secondary:   Antibiotic Use (Proportion of Subjects)   [ Time Frame: 6 months ]

3.  Secondary:   Antibiotic Use (Days of Use Per Subject)   [ Time Frame: 6 months ]

4.  Secondary:   Pulmonary Exacerbations   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was completed prior to reaching the pre-specified number of participants as the Data Safety Monitoring committee observed that efficacy had been reached.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marianne S. Muhlebach, PI
Organization: University of North Carolina, Chapel Hill
phone: (1) 919 966 1055
e-mail: Marianne_Muhlebach@med.unc.edu



Responsible Party: Marianne Muhlebach, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01349192     History of Changes
Other Study ID Numbers: STAR-too-10K0
Study First Received: May 4, 2011
Results First Received: November 2, 2016
Last Updated: April 5, 2017