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Cystic FibrosisPhase 2STAR-TooNCT01349192

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

A Phase 2 study testing Rifampin, Trimethoprim/Sulfamethoxazole and Minocycline in people with Cystic Fibrosis and Methicillin-resistant Staphylococcus Aureus, run by University of North Carolina, Chapel Hill at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Read more about this study

Who is it for?
Ages 4 to 45 years
What is being tested?
Rifampin, Trimethoprim/Sulfamethoxazole and Minocycline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
13 sitesUnited States
Study dates
Apr 2011to May 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Male or female ≥ 4 and ≤ 45 years of age at the Screening Visit.
  • Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
  • sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
  • two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
  • Abnormal nasal potential difference (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
  • First OR early repeat MRSA colonization defined as:
Show all 14Show fewer
  • First MRSA colonization: first documented isolation of MRSA from respiratory tract occurred ≤ 6 months prior to screening
  • OR Early repeat MRSA colonization:
  • MRSA was previously isolated from the respiratory tract (≤ 2 times), but this was followed by at least 1 year of documented negative cultures for MRSA as noted below:
  • -- At least 2 cultures performed at least 3 months apart to document 1 year of culture negativity. Each of these cultures should be documented to have been collected at least 1 week after end of any antibiotic prescription with MRSA activity.
  • Patient again recently positive for MRSA from the respiratory tract (within 6 months prior to screening)
  • Clinically stable with no significant changes in health status within the 14 days prior to screening
  • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
  • A repeat culture from the respiratory tract is obtained at screening but does not have to be positive to be able to enter the study.

Who cannot join

  • Received antibiotics with activity against MRSA within 28 days prior to screening (see study manual for list of antibiotics)
  • Use of an investigational agent within 28 days prior to screening
  • For subjects ≥ 6 years of age: FEV1 at screening < 30% of predicted for age based on the Wang (males < 18 years, females < 16 years) or Hankinson (males ≥ 18 years, females ≥ 16 years) standardized equations
  • MRSA from the screening culture resistant to rifampin OR resistant to both TMP/SMX and minocycline
  • History of intolerance to oral rifampin, or topical chlorhexidine or mupirocin
  • History of intolerance to both TMP/SMX and minocycline
Show all 14Show fewer
  • < 8 years of age and either allergic or intolerant to TMP/SMX or screening MRSA resistant to TMP/SMX
  • ≥ 8 years of age and allergic or intolerant to TMP/SMX and screening MRSA resistant to minocycline
  • ≥ 8 years of age and allergic or intolerant to minocycline and screening MRSA resistant to TMP/SMX
  • For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 15 of the study
  • Abnormal renal function at Screening, defined as estimated creatinine clearance <50 mL/min using the Cockcroft-Gault equation
  • Abnormal liver function at the time of screening, defined as ≥2x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT)
  • History of solid organ or hematological transplantation
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5212

  • The Children's Hospital

    Aurora, Colorado, 80045

  • The Children's Hospital-University of Birmingham

    Birmingham, Alabama, 35233

  • N.C Memorial Hospital and N.C Children's Hospital

    Chapel Hill, North Carolina, 27599

  • CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3026

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • University of Florida

    Gainesville, Florida, 32611

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Children's Hospitals and Clinics of Minnesota Minneapolis

    Minneapolis, Minnesota, 55404

  • Seattle Children's

    Seattle, Washington, 98145-9807

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)

Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA.

Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit.

Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.

Read the detailed description

The STAR-too study is a randomized, open label, multi-center study in CF patients with new MRSA isolated from the respiratory tract (sputum or oropharyngeal (OP) swab). The purpose of the study is to compare use of a two week eradication treatment protocol to an observational group treated for MRSA only when respiratory symptoms meet the criteria for a protocol defined pulmonary exacerbation during the first 28 days of the study. A total of 90 participants, four years of age or older, with new MRSA infection are planned to be randomized in a 1:1 fashion to either the treatment arm or to the observational control arm. Randomization is stratified by age, P. aeruginosa status at screening and site. Each participant randomized to the treatment arm receives two oral antibiotics for 14 days, topical antibacterial treatment of skin and nares, and a three week environmental decontamination for high risk areas and equipment. Each participant randomized to the observational control arm is followed clinically with usual care except to treat new or worsening pulmonary symptoms with antibiotics between screening and Day 28 only when participant meets criteria for a protocol defined exacerbation. Participants continue in the study for 6 months with study visits at Day 84 and Day 168 corresponding with their normal quarterly visits, this extension of observation provides additional data regarding natural history of MRSA infection and durability of the eradication protocol. The primary outcome is the proportion of participants with MRSA eradicated from respiratory tract cultures at Day 28. The secondary outcomes number of, and time to, pulmonary exacerbations, and use of antibiotics.

Being tested
Rifampin, Trimethoprim/Sulfamethoxazole, Minocycline, Mupirocin, chlorhexidine gluconate oral rinse
Keywords
MRSA, Cystic Fibrosis, Early Infection, Treatment
Medical subject headings
Cystic Fibrosis, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RifampinDrug

    Also called Rifadin, Rimactane

    Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.

  • Trimethoprim/SulfamethoxazoleDrug

    Also called Bactrim, Septra

    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.

  • MinocyclineDrug

    Also called Cleeravue-M, Dynacin, Minocin, Myrac, Solodyn, Vectrin

    only subjects greater or equal to 8 years of age, who are not able to tolerate TMP/SMX or whose screening MRSA is resistant to TMP/SMX should be prescribed minocycline.

    Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days not to exceed 200mg per day.

  • MupirocinDrug

    Also called Bactroban, Centany

    1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 14 days.

  • chlorhexidine gluconate oral rinseDrug

    for subjects able to swish without swallowing. 0.12% chlorhexidine gluconate oral rinse twice daily for 14 days.

  • 2% Chlorhexidine solution wipesDrug

    whole body wash solution wipes once daily for first 5 days.

  • Environmental DecontaminationBehavioural

    Also called Sani-Cloth Plus

    wipe down high touch surfaces and medical equipment with surface disinfecting wipes daily for the first 21 days.

    wash all linens and towels in hot water once weekly for three weeks.

Study groups in NCT01349192
Study groupRoleWhat they receive
TreatmentExperimentalSubjects are treated with two oral antibiotics, topical antibiotics, and are instructed to use environmental decontamination techniques.
Receives: Drug: Rifampin; Drug: Trimethoprim/Sulfamethoxazole; Drug: Minocycline; Drug: Mupirocin; Drug: chlorhexidine gluconate oral rinse; Drug: 2% Chlorhexidine solution wipes; Behavioral: Environmental Decontamination
ObservationalNo interventionSubjects 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRSA Culture Status

    Proportion of subjects with a negative culture for MRSA at Day 28.

    Measured: Day 28

Secondary outcomes (3)

  1. Antibiotic Use (Proportion of Subjects)

    Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study.

    Measured: 6 months

  2. Antibiotic Use (Days of Use Per Subject)

    Days of use of oral, inhaled, and IV antibiotics over the 6 month study.

    Measured: 6 months

  3. Pulmonary Exacerbations

    Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJan 2015
  4. Study completionMay 2015

Why it stopped: Interim review showed a statistically significant treatment effect and the DMC recommended that the study be stopped with ongoing follow-up of enrolled subjects

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01349192
Sponsor's protocol ID
STAR-too-10K0
Acronym
STAR-Too
Status last verified
Apr 2017
First submitted
4 May 2011
Last updated
15 May 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Lo DK, Muhlebach MS, Smyth AR. Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis. Cochrane Database Syst Rev. 2022 Dec 13;12(12):CD009650. doi: 10.1002/14651858.CD009650.pub5.

    PubMed 36511181

  • Muhlebach MS, Beckett V, Popowitch E, Miller MB, Baines A, Mayer-Hamblett N, Zemanick ET, Hoover WC, VanDalfsen JM, Campbell P, Goss CH; STAR-too study team. Microbiological efficacy of early MRSA treatment in cystic fibrosis in a randomised controlled trial. Thorax. 2017 Apr;72(4):318-326. doi: 10.1136/thoraxjnl-2016-208949. Epub 2016 Nov 15.

    PubMed 27852955

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rifampin, Trimethoprim/Sulfamethoxazole and Minocycline in people with Cystic Fibrosis and Methicillin-resistant Staphylococcus Aureus, run by University of North Carolina, Chapel Hill at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRSA Culture Status (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01349192, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.

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