A Phase 2 interventional study of Trimethoprim Sulfamethoxazole (TMP/SMX) and Minocycline in Cystic Fibrosis, sponsored by University of North Carolina, Chapel Hill. Completed at 9 sites in United States. Open to participants aged 2 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Treatment
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Among 20 studies in Cystic Fibrosis by University of North Carolina, Chapel Hill — 2 open to participants now, 4 under way, none of them phase 3. Cystic Fibrosis · University of North Carolina, Chapel Hill.
Among the 20 studies in Cystic Fibrosis by University of North Carolina, Chapel Hill, this one has the largest enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2018, is one of 3 in phase 2, and was the 15th registered.
1,621 studies on the registry are indexed under Cystic Fibrosis; 201 are open to participants now.
Browse Cystic Fibrosis studies →2 of the 20 studies in Cystic Fibrosis by University of North Carolina, Chapel Hill are open now, in 1 country. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in United States
Ages 18–99
University of North Carolina, Chapel Hill · Sites in United States
Ages 1 mo–99 yrs
By country, each count listing its studies:
Of the 156 Cystic Fibrosis studies recruiting now, 95 (61%) set no upper age limit and 45 (29%) stop at 75 or younger; 86 take children under 18; 41 take healthy volunteers.
This study: 2 Years to 45 Years · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2018.
This study's enrollment of 49 is above the median of 36 across 1,053 interventional studies indexed under Cystic Fibrosis.
Median enrollment 16 across the 13 interventional studies, 152 across the 7 observational. Of the 16 that completed or were terminated, 8 (50%) have results posted.
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University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Cystic Fibrosis by University of North Carolina, Chapel Hill, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Subjects with history of abnormal renal function will need screening labs showing normal function Abnormal renal function is defined as estimated \<50 mL/min using the:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Trimethoprim Sulfamethoxazole (TMP/SMX) · Drug: Minocycline · Drug: Mupirocin · Drug: Chlorhexidine Gluconate · Behavioral: Environmental Decontamination
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.
Also known as: Septra, Bactrim
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.
Also known as: Cleeravue-M, Dynacin, Minocin, Solodyn, Vectrin
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.
Also known as: Bactroban, Centany
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.
Also known as: Dyna-Hex
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.
Also known as: Sani-Cloth wipes
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.
Time frame: Day 28
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: 1. Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) 2. Oxygen saturation \<90% on room air or absolute decrease of ≥ 5% from Visit 1 3. New lobar infiltrate(s) or atelectasis on chest radiograph 4. Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: 1. Increased work of breathing or respiratory rate 2. New or increased adventitial sounds on lung exam 3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months 4. Increased cough 5. Decreased exercise tolerance or level of activity 6. Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
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
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: 1. Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) 2. Oxygen saturation \<90% on room air or absolute decrease of ≥ 5% from Visit 1 3. New lobar infiltrate(s) or atelectasis on chest radiograph 4. Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: 1. Increased work of breathing or respiratory rate 2. New or increased adventitial sounds on lung exam 3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months 4. Increased cough 5. Decreased exercise tolerance or level of activity 6. Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
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
Proportion treated with any 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
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: 1. Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) 2. Oxygen saturation \<90% on room air or absolute decrease of ≥ 5% from Visit 1 3. New lobar infiltrate(s) or atelectasis on chest radiograph 4. Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: 1. Increased work of breathing or respiratory rate 2. New or increased adventitial sounds on lung exam 3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months 4. Increased cough 5. Decreased exercise tolerance or level of activity 6. Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
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
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: 1. Absolute decrease in FEV1 ≥10% from Visit 1, unresponsive to albuterol (in participants able to perform spirometry) 2. Oxygen saturation \<90% on room air or absolute decrease of ≥ 5% from Visit 1 3. New lobar infiltrate(s) or atelectasis on chest radiograph 4. Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: 1. Increased work of breathing or respiratory rate 2. New or increased adventitial sounds on lung exam 3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months 4. Increased cough 5. Decreased exercise tolerance or level of activity 6. Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
Time frame: Period ranging from start of Baseline and continuing through Month 6
Proportion With a Negative Culture for MRSA at Day 56
MRSA Culture Status
Time frame: 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.
Time frame: Day 28
| Milestone | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| Started | 42 | 21 |
| Visit 2 evaluable for primary endpoint | 36 | 19 |
| Visit 4 final follow up | 31 | 17 |
| Completed | 36 | 17 |
| Not completed | 6 | 4 |
Descriptive summary with corresponding 95% confidence interval.
| proportion of participants | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| Proportion of STAR-TER Participants With a Positive MRSA Culture at Day 28 vs. Observational Arm of Historic STAR-Too Trial | 0.89 (0.74 to 0.97) | 0.74 (0.19 to 0.75) |
Pulmonary exacerbation is defined as having 1 of the major criteria or 2 minor signs/symptoms and fulfillment of symptom duration. Major criteria: 1. Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) 2. Oxygen saturation \<90% on room air or absolute decrease of ≥ 5% from Visit 1 3. New lobar infiltrate(s) or atelectasis on chest radiograph 4. Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: 1. Increased work of breathing or respiratory rate 2. New or increased adventitial sounds on lung exam 3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months 4. Increased cough 5. Decreased exercise tolerance or level of activity 6. Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
| proportion of participants | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| Proportion With a Protocol-defined Pulmonary Exacerbation Between Baseline and Day 28 Treated With Antibiotics Active Against MRSA | 0.03 | 0.29 |
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: 1. Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) 2. Oxygen saturation \<90% on room air or absolute decrease of ≥ 5% from Visit 1 3. New lobar infiltrate(s) or atelectasis on chest radiograph 4. Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: 1. Increased work of breathing or respiratory rate 2. New or increased adventitial sounds on lung exam 3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months 4. Increased cough 5. Decreased exercise tolerance or level of activity 6. Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
| proportion of participants | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| 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 | 0.03 | 0.68 |
Proportion treated with any oral, inhaled, or IV antibiotics over the six-month study
| proportion of participants | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| Proportion of Subjects Treated With Oral, Inhaled, or IV Antibiotics Over the Six-month Study | 0.28 | 0.68 |
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: 1. Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry) 2. Oxygen saturation \<90% on room air or absolute decrease of ≥ 5% from Visit 1 3. New lobar infiltrate(s) or atelectasis on chest radiograph 4. Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: 1. Increased work of breathing or respiratory rate 2. New or increased adventitial sounds on lung exam 3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months 4. Increased cough 5. Decreased exercise tolerance or level of activity 6. Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
| days | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| Time to Protocol-defined Pulmonary Exacerbation Over the Six-month Study | NA ± NA | 96.8 ± 69.8 |
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: 1. Absolute decrease in FEV1 ≥10% from Visit 1, unresponsive to albuterol (in participants able to perform spirometry) 2. Oxygen saturation \<90% on room air or absolute decrease of ≥ 5% from Visit 1 3. New lobar infiltrate(s) or atelectasis on chest radiograph 4. Hemoptysis (more than streaks on more than one occasion in past week) Minor signs/symptoms: 1. Increased work of breathing or respiratory rate 2. New or increased adventitial sounds on lung exam 3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months 4. Increased cough 5. Decreased exercise tolerance or level of activity 6. Increased chest congestion or change in sputum Signs/symptoms duration: initial symptom must have occurred for at least 5 days.
| exacerbations | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| Number of Protocol-defined Pulmonary Exacerbations Across All Participants Over the Six-month Study | 1 | 13 |
MRSA Culture Status
| proportion of participants | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| Proportion With a Negative Culture for MRSA at Day 56 | 0.35 | — |
Compliance refers to the amount of prescribed medication consumed based on diary data.
| proportion of participants | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| Proportion With >80% Compliance for Study Drug During the First 28 Days | 0.73 | — |
Collected over For the active STAR-TER trial participants, adverse events were collected from the time signing informed consent at Visit 1 until the participant completed the study or withdrew, a total of up to 6 months. Retrospective data reported for STAR-Too Trial was reported from the time of signing informed consent at Visit 1 until the participant completed the study or withdrew, a total of up to 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/36 (0%) | 3/36 (8.3%) | 12/42 (28.6%) |
| Historical Controls - STAR-Too Trial Observational Arm | 0/21 (0%) | 1/21 (4.8%) | 13/21 (61.9%) |
| Event | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 0/36 | 1/21 |
| Pulmonary exacerbationRespiratory, thoracic and mediastinal disorders | 1/36 | 0/21 |
| Drug-induced immune thrombocytopeniaBlood and lymphatic system disorders | 1/36 | 0/21 |
| ConstipationGastrointestinal disorders | 1/36 | 0/21 |
| PancreatitisGastrointestinal disorders | 1/36 | 0/21 |
| Event | Treatment | Historical Controls - STAR-Too Trial Observational Arm |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 4/42 | 9/21 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 1/42 | 3/21 |
| RashSkin and subcutaneous tissue disorders | 5/42 | 0/21 |
| infectionInfections and infestations | 5/42 | 0/21 |
| NauseaGastrointestinal disorders | 2/42 | 2/21 |
| Weight decreasedInvestigations | 0/42 | 2/21 |
| Decreased appetiteMetabolism and nutrition disorders | 1/42 | 2/21 |
| VomitingGastrointestinal disorders | 1/42 | 1/21 |
| PyrexiaGeneral disorders | 0/42 | 1/21 |
| Nasal (sinus) congestionRespiratory, thoracic and mediastinal disorders | 2/42 | 1/21 |
Data are not reported for six of the forty-two Treatment participants who did not reach the primary endpoint (Visit 2).
| Age, Categorical(Participants) | Treatment | Historical Controls - STAR-Too Trial Observational Arm | Total |
|---|---|---|---|
| <=18 years | 31 | 20 | 51 |
| Between 18 and 65 years | 5 | 1 | 6 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Treatment | Historical Controls - STAR-Too Trial Observational Arm | Total |
|---|---|---|---|
| Female | 21 | 10 | 31 |
| Male | 15 | 11 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Treatment | Historical Controls - STAR-Too Trial Observational Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 30 | 19 | 49 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Treatment | Historical Controls - STAR-Too Trial Observational Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 32 | 19 | 51 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Treatment | Historical Controls - STAR-Too Trial Observational Arm | Total |
|---|---|---|---|
| United States | 36 | 21 | 57 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Sep 2025, 89 months.
Results were first posted in Sep 2026, 11 months after primary completion.
Of 57 phase 2 interventional studies under Cystic Fibrosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 89 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Minocycline · Mupirocin · Chlorhexidine gluconate
University of North Carolina, Chapel Hill →