Skip to main content

Table 2 Comparison of CleanUP-IPF with EME-TIPAC eligibility criteria

From: Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy – the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial

Inclusion Criteria 
CleanUP-IPF
(NCT 02759120)
EME-TIPAC
(ISRCTN 17464641)
1. ≥ 40 years of age
2. Diagnosed with IPF by enrolling investigator
3. Signed informed consent
1. Age greater than or equal to 40 years
2. A diagnosis of IPF based on multi-disciplinary consensus according to the latest international guidelines.
3. Patients may receive oral prednisolone up to a dose of 10 mg per day, anti-oxidant therapy, pirfenidone or other licensed medication for IPF e.g. nintedanib. Patients should be on a stable treatment regimen for at least 4 weeks to ensure baseline values are representative.
4. MRC dyspnea score of greater than 1.
5. Able to provide informed consent
Exclusion CriteriaExclusion Criteria (as of January 7, 2019)*
1. Received antimicrobial therapy in the past 30 days for treatment purposes (antibiotic prophylaxis for procedures do not meet criteria, nor do antivirals)
2. Contraindicated for antibiotic therapy
3. Pregnant or anticipate becoming pregnant
4. Use of an investigational study agent for IPF therapy within the past 30 days, or an IV infusion with a half-life of four (4) weeks
5. Concomitant immunosuppression with azathioprine, mycophenolate, cyclophosphamide, or cyclosporine.
1. FVC > 75% predicted.
2. A recognized significant co-existing respiratory disease, defined as a respiratory condition that exhibits a greater clinical effect on respiratory symptoms and disease progression than IPF as determined by the principal investigator.
3. Patients with airways disease defined as forced expiratory volume in 1 s (FEV1)/FVC < 60%
4. A self-reported respiratory tract infection within 4 weeks of screening defined as two or more of cough, sputum or breathlessness and requiring antimicrobial therapy.
5. Significant medical, surgical or psychiatric disease that in the opinion of the patient’s attending physician would affect subject safety or influence the study outcome including liver (Serum transaminase > 3 x upper limit of normal (ULN), Bilirubin > 2 x ULN) and renal failure (creatinine clearance < 30 ml/min).
6. Patients receiving recognized immunosuppressant medication (except prednisolone above) including azathioprine and mycophenolate mofetil.
7. Female subjects must be of non-childbearing potential, defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH > 40mIU/ml or females who have had a hysterectomy or bilateral oophorectomy at least 6 weeks prior to enrollment.
8. Allergy or intolerance to trimethoprim or sulphonamides or their combination.
9. Untreated folate or B12 deficiency.
10. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency measured at screening in males of African, Asian or Mediterranean descent.
11. Receipt of an investigational drug or biological agent within the 4 weeks prior to study entry or 5 times the half-life if longer.
12. Receipt of short course antibiotic therapy for respiratory and other infections within 4 weeks of screening.
13. Patients receiving long term (defined as > 1 month of therapy) prophylactic antibiotic treatment will not be eligible as this may have an impact on lung microbiota. Such patients may enroll in the EME-TIPAC trial, if this is supported by their clinician, after a ‘wash-out period’ of 3 months.
14. Serum Potassium greater than 5.0 mmol/l due to the potentially increased risk of hyperkalemia in patients taking co-trimoxazole in combination with potassium sparing diuretics (including angiotensin converting enzyme inhibitors or angiotensin receptor blockers)
  1. *The study eligibility criteria are taken verbatim from the official trial registration (http://www.isrctn.com/ISRCTN17464641)