Trial Outcomes & Findings for CleanUP IPF for the Pulmonary Trials Cooperative (NCT NCT02759120)

NCT ID: NCT02759120

Last Updated: 2021-04-08

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

513 participants

Primary outcome timeframe

Randomization to up to 35 months

Results posted on

2021-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Antimicrobial Therapy Plus Standard of Care Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Overall Study STARTED	254	259
Overall Study COMPLETED	169	180
Overall Study NOT COMPLETED	85	79

Reasons for withdrawal

Reasons for withdrawal
Measure	Antimicrobial Therapy Plus Standard of Care Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Overall Study Death	34	36
Overall Study Lost to Follow-up	4	7
Overall Study Physician Decision	3	0
Overall Study Withdrawal by Subject	28	15
Overall Study Moved out of area	3	4
Overall Study Lung transplant	3	5
Overall Study Other reason not completed	10	12

Baseline Characteristics

Data could not be located.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Randomization to up to 35 months

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality	52 Participants	56 Participants

SECONDARY outcome

Timeframe: Randomization to up to 35 months

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Number of Participants With Death From Any Cause	37 Participants	37 Participants

SECONDARY outcome

Timeframe: Randomization to up to 35 months

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Number of Participants With First Non-elective, Respiratory Hospitalization	36 Participants	31 Participants

SECONDARY outcome

Timeframe: Randomization to up to 35 months

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Number of Participants With First Non-elective, All-cause Hospitalization	54 Participants	47 Participants

SECONDARY outcome

Timeframe: Randomization to up to 35 months

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Total Number of Non-elective Respiratory Hospitalizations	55 hospitalizations	43 hospitalizations

SECONDARY outcome

Timeframe: Randomization to up to 35 months

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Total Number of Non-elective All-cause Hospitalizations	72 hospitalizations	52 hospitalizations

SECONDARY outcome

Timeframe: Randomization to 12 months

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Percent Change in Forced Vital Capacity (FVC)	-2.99 percent change Interval -4.23 to -1.75	-4.13 percent change Interval -5.28 to -2.98

SECONDARY outcome

Timeframe: Randomization to 12 months

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)	-1.72 percent change Interval -3.27 to -0.18	-2.56 percent change Interval -4.54 to -0.59

SECONDARY outcome

Timeframe: Randomization to up to 35 months

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Total Number of Respiratory Infections	34 respiratory infections	49 respiratory infections

SECONDARY outcome

Timeframe: Randomization to 12 months

Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (0 - 120 range). A lower score indicates a better health score. The UCSD-Shortness of Breath Questionnaire assesses the severity of shortness of breath during specific activities of daily living.

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Change in UCSD-Shortness of Breath Questionnaire	5.67 Scores on a scale Interval 2.75 to 8.59	6.29 Scores on a scale Interval 3.54 to 9.04

SECONDARY outcome

Timeframe: Randomization to 12 months

Fatigue Severity Scale score (1 - 7 range). A lower score indicates a better health score. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle.

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Change in Fatigue Severity Scale Score	0.24 Scores on a scale Interval -0.02 to 0.49	0.13 Scores on a scale Interval -0.12 to 0.37

SECONDARY outcome

Timeframe: Randomization to 12 months

Leicester Cough Questionnaire score (3 - 21 range). A higher score indicates a better health score. The Leicester Cough Questionnaire measures quality of life in people with a chronic cough.

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Change in Leicester Cough Questionnaire Score	-0.58 Scores on a scale Interval -1.15 to 0.0	-0.58 Scores on a scale Interval -1.13 to -0.04

SECONDARY outcome

Timeframe: Randomization to 12 months

European Quality of Life-5 dimensions (EQ-5D) score (0 - 1 range). A higher score indicates a better health score. The EQ-5D measures quality of life across 5 dimensions (1. Mobility, 2. Self-care, 3. Usual activities, 4. Pain/discomfort, 5. Anxiety/depression.

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Change in EuroQol Index (EQ-5D) Score	-0.040 Scores on a scale Interval -0.071 to -0.009	-0.046 Scores on a scale Interval -0.075 to -0.016

SECONDARY outcome

Timeframe: Randomization to 12 months

Change in ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) score (0 - 1 range). A lower score indicates a better health score. The ICEpop CAPability measure for Older people (ICECAP-O) is intended for use in economic evaluations of care services for older people.

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Change in ICEpop CAPability Measure for Older People (ICECAP-O) Score	0.027 Scores on a scale Interval -0.003 to 0.057	0.017 Scores on a scale Interval -0.011 to 0.045

SECONDARY outcome

Timeframe: Randomization to 12 months

Change in Short Form-12 health survey (SF-12) 6D score (0.29 - 1.00 range). A higher indicates a better health score. The SF-12 6D score provides and economic evaluation.

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Change in Short Form-12 Health Survey (SF-12) 6D Score	-0.013 Scores on a scale Interval -0.031 to 0.005	-0.031 Scores on a scale Interval -0.048 to -0.014

SECONDARY outcome

Timeframe: Randomization to 12 months

Change in short form-12 health survey (SF-12) physical component summary (PSC) score (0 - 100 range). A higher score indicates a better health score. The short form-12 health survey physical score assesses limitations in physical activities because of health problems.

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Change in Short Form-12 Health Survey (SF-12) Physical Score	-1.36 Scores on a scale Interval -2.54 to -0.18	-1.88 Scores on a scale Interval -3.0 to -0.75

SECONDARY outcome

Timeframe: Randomization to 12 months

Change in short form-12 health survey (SF-12) mental component summary (MCS) score (0 - 100 range). A higher score indicates a better health score. The short form-12 health survey (SF-12) mental component summary (MCS) assesses general mental health.

Outcome measures

Outcome measures
Measure	Antimicrobial Therapy Plus Standard of Care n=254 Participants Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 Participants Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Change in SF-12 Health Survey (SF-12) Mental Score	-1.29 Scores on a scale Interval -2.67 to 0.09	-1.59 Scores on a scale Interval -2.91 to -0.27

Adverse Events

Antimicrobial Therapy Plus Standard of Care

Serious events: 71 serious events

Other events: 62 other events

Deaths: 37 deaths

Standard of Care

Serious events: 65 serious events

Other events: 23 other events

Deaths: 37 deaths

Serious adverse events

Serious adverse events
Measure	Antimicrobial Therapy Plus Standard of Care n=254 participants at risk Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 participants at risk Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	5.5% 14/254 • Number of events 16 • Thirty-five months	1.9% 5/259 • Number of events 6 • Thirty-five months
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 4/254 • Number of events 4 • Thirty-five months	1.5% 4/259 • Number of events 4 • Thirty-five months
Respiratory, thoracic and mediastinal disorders Dyspnea	2.0% 5/254 • Number of events 5 • Thirty-five months	0.77% 2/259 • Number of events 2 • Thirty-five months
Respiratory, thoracic and mediastinal disorders Pulmonary embollism	0.79% 2/254 • Number of events 2 • Thirty-five months	1.2% 3/259 • Number of events 3 • Thirty-five months
Infections and infestations Pneumonia	2.0% 5/254 • Number of events 5 • Thirty-five months	2.7% 7/259 • Number of events 7 • Thirty-five months
Cardiac disorders Cardiac disorder	4.3% 11/254 • Number of events 12 • Thirty-five months	4.2% 11/259 • Number of events 11 • Thirty-five months
Nervous system disorders Nervous system disorder	3.1% 8/254 • Number of events 8 • Thirty-five months	1.2% 3/259 • Number of events 3 • Thirty-five months
Nervous system disorders Syncope	1.2% 3/254 • Number of events 3 • Thirty-five months	0.00% 0/259 • Thirty-five months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	16.5% 42/254 • Number of events 51 • Thirty-five months	10.0% 26/259 • Number of events 29 • Thirty-five months
Gastrointestinal disorders Gastrointestinal disorder	1.2% 3/254 • Number of events 3 • Thirty-five months	1.5% 4/259 • Number of events 4 • Thirty-five months
General disorders General disorders and administrative site conditions	2.0% 5/254 • Number of events 6 • Thirty-five months	0.39% 1/259 • Number of events 1 • Thirty-five months
Metabolism and nutrition disorders Metabolic and nutrition disorders	0.79% 2/254 • Number of events 2 • Thirty-five months	1.5% 4/259 • Number of events 4 • Thirty-five months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	0.79% 2/254 • Number of events 2 • Thirty-five months	1.2% 3/259 • Number of events 3 • Thirty-five months
Vascular disorders Vascular disorders	1.2% 3/254 • Number of events 3 • Thirty-five months	0.39% 1/259 • Number of events 1 • Thirty-five months
Injury, poisoning and procedural complications Injury, poisoning, and procedural complications	0.79% 2/254 • Number of events 2 • Thirty-five months	0.39% 1/259 • Number of events 1 • Thirty-five months
Renal and urinary disorders Renal and urinary disorders	0.79% 2/254 • Number of events 2 • Thirty-five months	0.39% 1/259 • Number of events 1 • Thirty-five months
Hepatobiliary disorders Hepatobiliary disorders	0.79% 2/254 • Number of events 2 • Thirty-five months	0.00% 0/259 • Thirty-five months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm benign, malignant, and unspecified	0.39% 1/254 • Number of events 1 • Thirty-five months	0.39% 1/259 • Number of events 1 • Thirty-five months
Endocrine disorders Endocrine disorders	0.39% 1/254 • Number of events 1 • Thirty-five months	0.00% 0/259 • Thirty-five months
Immune system disorders Immune system disorders	0.00% 0/254 • Thirty-five months	0.39% 1/259 • Number of events 1 • Thirty-five months
Investigations Investigations	0.00% 0/254 • Thirty-five months	0.39% 1/259 • Number of events 2 • Thirty-five months
Product Issues Product issues	0.00% 0/254 • Thirty-five months	0.39% 1/259 • Number of events 1 • Thirty-five months
Infections and infestations Infections and infestations	2.8% 7/254 • Number of events 9 • Thirty-five months	6.6% 17/259 • Number of events 17 • Thirty-five months

Other adverse events

Other adverse events
Measure	Antimicrobial Therapy Plus Standard of Care n=254 participants at risk Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months	Standard of Care n=259 participants at risk Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care
Cardiac disorders Arrhythmia	0.79% 2/254 • Number of events 2 • Thirty-five months	1.9% 5/259 • Number of events 5 • Thirty-five months
Gastrointestinal disorders Vomiting	4.7% 12/254 • Number of events 14 • Thirty-five months	0.77% 2/259 • Number of events 2 • Thirty-five months
Metabolism and nutrition disorders Hyperkalemia	3.9% 10/254 • Number of events 11 • Thirty-five months	0.77% 2/259 • Number of events 2 • Thirty-five months
Skin and subcutaneous tissue disorders Rash	6.7% 17/254 • Number of events 22 • Thirty-five months	0.00% 0/259 • Thirty-five months
Gastrointestinal disorders Diarrhea	10.2% 26/254 • Number of events 29 • Thirty-five months	3.1% 8/259 • Number of events 8 • Thirty-five months
General disorders Other	3.1% 8/254 • Number of events 8 • Thirty-five months	2.7% 7/259 • Number of events 7 • Thirty-five months

Additional Information

Elizabeth Peters

Weill Cornell Medicine

Phone: 646-962-2742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place