Cystic FibrosisPhase 2STAR-TERNCT03489629
STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)
A Phase 2 study testing Trimethoprim Sulfamethoxazole (TMP/SMX), Minocycline and Mupirocin in people with Cystic Fibrosis, run by University of North Carolina, Chapel Hill at 9 sites in United States.
Trial summary
To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 2 to 45 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Trimethoprim Sulfamethoxazole (TMP/SMX), Minocycline and Mupirocin
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Apr 2018to 31 Jan 2026
- 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 2 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female ≥ 2 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 milliequivalents/liter by quantitative 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)
- First OR early MRSA colonization defined as:
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- First MRSA colonization: first documented isolation of MRSA from respiratory tract occurred ≤ 6 months prior to screening
- Early MRSA colonization: MRSA was previously isolated from the respiratory tract ≤ 2 times over the past 3.5 years, but this was followed by at least 1 year of documented negative cultures for MRSA
- MRSA is available to the central laboratory - either the incident MRSA isolate from the clinic visit or the subject is MRSA positive at the screening visit
- 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
Who cannot join
- Received antibiotics with activity against MRSA within 28 days prior to screening
- Use of an investigational agent within 28 days prior to screening
- For subjects ≥ 6 years of age: FEV1 at screening < 25% 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 or the most recent clinical care visit within 6 months prior to screening resistant to TMP/SMX
- History of intolerance to topical chlorhexidine or mupirocin
- History of intolerance to both TMP/SMX and minocycline
Show all 15Show fewer
- < 8 years of age and allergic or intolerant to TMP/SMX
- ≥ 8 years of age and allergic or intolerant to TMP/SMX and MRSA isolate (from screening or clinical care visit)is resistant to minocycline
- For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 42 of the study
- Subjects with history of abnormal renal function will need screening labs showing normal function Abnormal renal function is defined as estimated creatinine clearance <50 mL/min using the:
- Bedside Schwartz Equation for subjects <18 years of age, and
- Levey Glomerular filtration rate (GFR) Equation for subjects ≥ 18 years of age.
- Subjects with a history of abnormal liver function will need to have screening labs showing normal transaminases. Liver dysfunction is defined as ≥3x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT) or abnormal synthetic function
- 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
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
N.C. Memorial Hospital and N.C. Children's Hospital
Chapel Hill, North Carolina, 27599
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Cook Children's Medical Center
Fort Worth, Texas, 76104
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Washington Medical Center and Seattle Children's
Seattle, Washington, 98195
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.
Read the detailed description
This is an open-label, multi-center interventional trial in Cystic Fibrosis (CF) patients with new MRSA isolated from the respiratory tract (oropharyngeal (OP) = OP swab, sputum, or bronchoscopy) at a clinical encounter.
Forty-two subjects with new MRSA infection will be enrolled and will receive two weeks of oral trimethoprim-sulfamethoxazole (TMP-SMX) or minocycline depending on age, allergies and antibiotic resistance of prior isolate for 14 days, and nasal mupirocin for 5 days. Subjects old enough to do so will use oral disinfectant gurgle (0.12% chlorhexidine gluconate oral rinse) for 14 days. The primary endpoint will be the proportion of positive MRSA respiratory cultures at Day 28 and this will be compared to our prior STAR-Too results.
Subjects will then have a 14 day wash-out period (i.e., no TMP-SMX or minocycline from Day 14 to Day 28) and all participants will repeat the treatment protocol from Day 29 to Day 42. Repeat cultures will be done at day 56 ± 7 days, most likely combined with their next clinic visit. Results of Day 56 cultures will be an exploratory, secondary outcome.
A subsequent visit will be 3 months later with their routine clinic appointment. Any interim clinic visits will be used to obtain repeat cultures and clinical data.
Assessment of MRSA culture status will be by OP swab for all subjects, with additional sputum in those who expectorate.
Total duration of an individual subject's participation will be six months. Total duration of the study is expected to be 42 months, which includes data analyses and publication.
Due to COVID 19 restrictions, a study amendment was filed in March 2020 for subjects currently active subjects that allowed remote study visit for V3 and V4. Cultures were collected at home and mailed to the Core Study lab, clinical case forms and surveys were completed via video visits. These changes were approved by each study site that this was relevant to i.e. 4 study sites had subjects active at that time.
- Conditions
- Cystic Fibrosis
- Being tested
- Trimethoprim Sulfamethoxazole (TMP/SMX), Minocycline, Mupirocin, Chlorhexidine Gluconate, Environmental Decontamination
- Keywords
- Methicillin-resistant Staphylococcus aureus (MRSA), Early infection, Treatment, Forced Expiratory Volume in 1 Second (FEV1)
- 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.
Trimethoprim Sulfamethoxazole (TMP/SMX)Drug
Also called Septra, Bactrim
Dosing if < 40 kg: 8 mg/kg trimethoprim/40 mg/kg trimethoprim sulfamethoxazole given twice daily for 14 days during Days 1-14 and Days 29-42.
Dosing is ≥ 40 kg: 320 mg/1600 mg twice daily for 14 days during Days 1-14 and Days 29-42.
MinocyclineDrug
Also called Cleeravue-M, Dynacin, Minocin, Solodyn
If a subject has an allergy to or intolerance to TMP/SMX, they may be treated with minocycline provided they are 8 years of age or older.
Dosing if < 50 kg: 2 mg/kg orally twice daily for 14 days during Days 1-14 and Days 29-42.
Dosing if ≥ 50 kg: 100 mg twice daily for 14 days during Days 1-14 and Days 29-42.
MupirocinDrug
Also called Bactroban, Centany
1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 5 days during Days 1-5 and Days 29-33.
Chlorhexidine GluconateDrug
Also called Dyna-Hex
For subjects able to swish without swallowing, 0.12% chlorhexidine gluconate oral rinse will be used twice daily for 14 days during Days 1-14 and Days 29-42.
Environmental DecontaminationBehavioural
Also called Sani-Cloth wipes
Subjects will be instructed to wipe down all high touch surfaces and medical equipment with surface disinfection wipes daily during Days 1-21 and Days 29-49.
Subjects will also be instructed to wash all linens and towels in hot water once weekly during weeks 1-3 and weeks 5-7.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects are treated with one oral antibiotic, one topical antibiotic, an oral rinse, and instructed to use environmental decontamination techniques.
Trimethoprim Sulfamethoxazole (TMP/SMX) is the primary oral antibiotic to be used. Subjects with allergy or intolerance to TMP_SMX will use minocycline as an alternative antibiotic. Topical antibiotics are nasal Mupirocin, and the oral rinse/gurgle with 0.12% chlorhexidine gluconate. Receives: Drug: Trimethoprim Sulfamethoxazole (TMP/SMX); Drug: Minocycline; Drug: Mupirocin; Drug: Chlorhexidine Gluconate; Behavioral: Environmental Decontamination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of STAR-TER Participants With a Positive MRSA Culture at Day 28 vs. Observational Arm of Historic STAR-Too Trial
Descriptive summary with corresponding 95% confidence interval.
Measured: Day 28
Secondary outcomes (7)
Proportion With a Protocol-defined Pulmonary Exacerbation Between Baseline and Day 28 Treated With Antibiotics Active Against MRSA
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 minor signs/symptoms and fulfillment of symptom duration.
Major criteria:
- Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry)
- Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1
- New lobar infiltrate(s) or atelectasis on chest radiograph
- Hemoptysis (more than streaks on more than one occasion in past week)
Minor signs/symptoms:
- Increased work of breathing or respiratory rate
- New or increased adventitial sounds on lung exam
- Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months
- Increased cough
- Decreased exercise tolerance or level of activity
- Increased chest congestion or change in sputum
Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measured: Period ranging from start of Baseline and continuing through Day 28
Proportion With a Protocol-defined Pulmonary Exacerbation Between Baseline and Day 28 Treated With Any Oral, Inhaled, or IV Antibiotics Regardless of Potential Activity Against MRSA
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration.
Major criteria:
- Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry)
- Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1
- New lobar infiltrate(s) or atelectasis on chest radiograph
- Hemoptysis (more than streaks on more than one occasion in past week)
Minor signs/symptoms:
- Increased work of breathing or respiratory rate
- New or increased adventitial sounds on lung exam
- Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months
- Increased cough
- Decreased exercise tolerance or level of activity
- Increased chest congestion or change in sputum
Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measured: Period ranging from start of Baseline and continuing through Day 28
Proportion of Subjects Treated With Oral, Inhaled, or IV Antibiotics Over the Six-month Study
Proportion treated with any oral, inhaled, or IV antibiotics over the six-month study
Measured: Period ranging from start of Baseline and continuing through Month 6
Time to Protocol-defined Pulmonary Exacerbation Over the Six-month Study
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration.
Major criteria:
- Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry)
- Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1
- New lobar infiltrate(s) or atelectasis on chest radiograph
- Hemoptysis (more than streaks on more than one occasion in past week)
Minor signs/symptoms:
- Increased work of breathing or respiratory rate
- New or increased adventitial sounds on lung exam
- Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months
- Increased cough
- Decreased exercise tolerance or level of activity
- Increased chest congestion or change in sputum
Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measured: Period ranging from start of Baseline and continuing through Month 6
Number of Protocol-defined Pulmonary Exacerbations Across All Participants Over the Six-month Study
Pulmonary exacerbation defined as having 1 of the major criteria or 2 of the minor signs/symptoms. Pulmonary exacerbations recorded as number of exacerbations across all participants.
Major criteria:
- Absolute decrease in FEV1 ≥10% from Visit 1, unresponsive to albuterol (in participants able to perform spirometry)
- Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1
- New lobar infiltrate(s) or atelectasis on chest radiograph
- Hemoptysis (more than streaks on more than one occasion in past week)
Minor signs/symptoms:
- Increased work of breathing or respiratory rate
- New or increased adventitial sounds on lung exam
- Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months
- Increased cough
- Decreased exercise tolerance or level of activity
- Increased chest congestion or change in sputum
Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Measured: Period ranging from start of Baseline and continuing through Month 6
Proportion With a Negative Culture for MRSA at Day 56
MRSA Culture Status
Measured: Day 56
Proportion With >80% Compliance for Study Drug During the First 28 Days
Compliance refers to the amount of prescribed medication consumed based on diary data.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start3 Apr 2018
- Primary completion30 Sep 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Cook Children's Medical Center, Indiana University, University of Michigan, University of Texas Southwestern Medical Center, St. Louis Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Marianne Muhlebach, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489629
- Sponsor's protocol ID
- 17-2144
- Acronym
- STAR-TER
- Status last verified
- Feb 2026
- First submitted
- 29 Mar 2018
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)
- ClinicalTrials.gov ID
- NCT03489629
- Acronym / sponsor ID
- STAR-TER / 17-2144
- Conditions
- Cystic Fibrosis
- Keywords
- Methicillin-resistant Staphylococcus aureus (MRSA), Early infection, Treatment, Forced Expiratory Volume in 1 Second (FEV1)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Washington, Cook Children's Medical Center, Indiana University, University of Michigan, University of Texas Southwestern Medical Center, St. Louis Children's Hospital
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Posted 15 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.
Detailed description
This is an open-label, multi-center interventional trial in Cystic Fibrosis (CF) patients with new MRSA isolated from the respiratory tract (oropharyngeal (OP) = OP swab, sputum, or bronchoscopy) at a clinical encounter.
Forty-two subjects with new MRSA infection will be enrolled and will receive two weeks of oral trimethoprim-sulfamethoxazole (TMP-SMX) or minocycline depending on age, allergies and antibiotic resistance of prior isolate for 14 days, and nasal mupirocin for 5 days. Subjects old enough to do so will use oral disinfectant gurgle (0.12% chlorhexidine gluconate oral rinse) for 14 days. The primary endpoint will be the proportion of positive MRSA respiratory cultures at Day 28 and this will be compared to our prior STAR-Too results.
Subjects will then have a 14 day wash-out period (i.e., no TMP-SMX or minocycline from Day 14 to Day 28) and all participants will repeat the treatment protocol from Day 29 to Day 42. Repeat cultures will be done at day 56 ± 7 days, most likely combined with their next clinic visit. Results of Day 56 cultures will be an exploratory, secondary outcome.
A subsequent visit will be 3 months later with their routine clinic appointment. Any interim clinic visits will be used to obtain repeat cultures and clinical data.
Assessment of MRSA culture status will be by OP swab for all subjects, with additional sputum in those who expectorate.
Total duration of an individual subject's participation will be six months. Total duration of the study is expected to be 42 months, which includes data analyses and publication.
Due to COVID 19 restrictions, a study amendment was filed in March 2020 for subjects currently active subjects that allowed remote study visit for V3 and V4. Cultures were collected at home and mailed to the Core Study lab, clinical case forms and surveys were completed via video visits. These changes were approved by each study site that this was relevant to i.e. 4 study sites had subjects active at that time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Trimethoprim Sulfamethoxazole (TMP/SMX), Drug: Minocycline, Drug: Mupirocin, Drug: Chlorhexidine Gluconate, Behavioral: Environmental DecontaminationSubjects are treated with one oral antibiotic, one topical antibiotic, an oral rinse, and instructed to use environmental decontamination techniques. Trimethoprim Sulfamethoxazole (TMP/SMX) is the primary oral antibiotic to be used. Subjects with allergy or intolerance to TMP_SMX will use minocycline as an alternative antibiotic. Topical antibiotics are nasal Mupirocin, and the oral rinse/gurgle with 0.12% chlorhexidine gluconate. |
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Male or female ≥ 2 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:
- First OR early MRSA colonization defined as:
- MRSA is available to the central laboratory - either the incident MRSA isolate from the clinic visit or the subject is MRSA positive at the screening visit
- Clinically stable with no significant changes in health status within the 14 days prior to screening
Key exclusion criteria (15 listed)
- Received antibiotics with activity against MRSA within 28 days prior to screening
- Use of an investigational agent within 28 days prior to screening
- For subjects ≥ 6 years of age: FEV1 at screening < 25% 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 or the most recent clinical care visit within 6 months prior to screening resistant to TMP/SMX
- History of intolerance to topical chlorhexidine or mupirocin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim Sulfamethoxazole (TMP/SMX)Also: Septra, BactrimDosing if < 40 kg: 8 mg/kg trimethoprim/40 mg/kg trimethoprim sulfamethoxazole given twice daily for 14 days during Days 1-14 and Days 29-42. Dosing is ≥ 40 kg: 320 mg/1600 mg twice daily for 14 days during Days 1-14 and Days 29-42. | Drug | Treatment |
| MinocyclineAlso: Cleeravue-M, Dynacin, Minocin, SolodynIf a subject has an allergy to or intolerance to TMP/SMX, they may be treated with minocycline provided they are 8 years of age or older. Dosing if < 50 kg: 2 mg/kg orally twice daily for 14 days during Days 1-14 and Days 29-42. Dosing if ≥ 50 kg: 100 mg twice daily for 14 days during Days 1-14 and Days 29-42. | Drug | Treatment |
| MupirocinAlso: Bactroban, Centany1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 5 days during Days 1-5 and Days 29-33. | Drug | Treatment |
| Chlorhexidine GluconateAlso: Dyna-HexFor subjects able to swish without swallowing, 0.12% chlorhexidine gluconate oral rinse will be used twice daily for 14 days during Days 1-14 and Days 29-42. | Drug | Treatment |
| Environmental DecontaminationAlso: Sani-Cloth wipesSubjects will be instructed to wipe down all high touch surfaces and medical equipment with surface disinfection wipes daily during Days 1-21 and Days 29-49. Subjects will also be instructed to wash all linens and towels in hot water once weekly during weeks 1-3 and weeks 5-7. | Behavioural | Treatment |
Primary outcome
Proportion of STAR-TER Participants With a Positive MRSA Culture at Day 28 vs. Observational Arm of Historic STAR-Too Trial
Time frame: Day 28
Descriptive summary with corresponding 95% confidence interval.
7 secondary outcomes
Proportion With a Protocol-defined Pulmonary Exacerbation Between Baseline and Day 28 Treated With Antibiotics Active Against MRSA
Time frame: Period ranging from start of Baseline and continuing through Day 28
Proportion With a Protocol-defined Pulmonary Exacerbation Between Baseline and Day 28 Treated With Any Oral, Inhaled, or IV Antibiotics Regardless of Potential Activity Against MRSA
Time frame: Period ranging from start of Baseline and continuing through Day 28
Proportion of Subjects Treated With Oral, Inhaled, or IV Antibiotics Over the Six-month Study
Time frame: Period ranging from start of Baseline and continuing through Month 6
Time to Protocol-defined Pulmonary Exacerbation Over the Six-month Study
Time frame: Period ranging from start of Baseline and continuing through Month 6
Number of Protocol-defined Pulmonary Exacerbations Across All Participants Over the Six-month Study
Time frame: Period ranging from start of Baseline and continuing through Month 6
Proportion With a Negative Culture for MRSA at Day 56
Time frame: Day 56
Proportion With >80% Compliance for Study Drug During the First 28 Days
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27852955Muhlebach 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Muhlebach, MD principal investigator
University of North Carolina, Chapel Hill
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trimethoprim Sulfamethoxazole (TMP/SMX), Minocycline and Mupirocin in people with Cystic Fibrosis, run by University of North Carolina, Chapel Hill at 9 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 11 inclusion and 15 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: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Sep 2026). 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?
Proportion of STAR-TER Participants With a Positive MRSA Culture at Day 28 vs. Observational Arm of Historic STAR-Too Trial (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 NCT03489629, which also lists 1 linked publication.
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 Sep 2026.