Trial · NCT02759120

CleanUP IPF for the Pulmonary Trials Cooperative

NCT02759120, Phase 3, Terminated, Weill Medical College of Cornell University; results first posted 2021-03-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. CleanUP IPF for the Pulmonary Trials Cooperative. Trials, record NCT02759120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02759120

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: CleanUP IPF for the Pulmonary Trials Cooperative
NCT number: NCT02759120
Status: Terminated
Phases: Phase 3
Enrollment: 513 participants, actual
Lead sponsor: Weill Medical College of Cornell University
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: Antimicrobial therapy: Co-trimoxazole or Doxycycline, No Intervention: Standard of Care
First posted: 2016-05-03
Last updated: 2021-04-08
Results first posted: 2021-03-03

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality	Randomization to up to 35 months
Secondary	Number of Participants With Death From Any Cause	Randomization to up to 35 months
Secondary	Number of Participants With First Non-elective, Respiratory Hospitalization	Randomization to up to 35 months
Secondary	Number of Participants With First Non-elective, All-cause Hospitalization	Randomization to up to 35 months
Secondary	Total Number of Non-elective Respiratory Hospitalizations	Randomization to up to 35 months
Secondary	Total Number of Non-elective All-cause Hospitalizations	Randomization to up to 35 months
Secondary	Percent Change in Forced Vital Capacity (FVC)	Randomization to 12 months
Secondary	Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)	Randomization to 12 months
Secondary	Total Number of Respiratory Infections	Randomization to up to 35 months
Secondary	Change in UCSD-Shortness of Breath Questionnaire	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.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality	Randomization to up to 35 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Death From Any Cause	Randomization to up to 35 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With First Non-elective, Respiratory Hospitalization	Randomization to up to 35 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With First Non-elective, All-cause Hospitalization	Randomization to up to 35 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Total Number of Non-elective Respiratory Hospitalizations	Randomization to up to 35 months	hospitalizations	NUMBER
SECONDARY	Total Number of Non-elective All-cause Hospitalizations	Randomization to up to 35 months	hospitalizations	NUMBER
SECONDARY	Percent Change in Forced Vital Capacity (FVC)	Randomization to 12 months	percent change	MEAN
SECONDARY	Percent Change in Diffusion Capacity of Lungs for Carbon Monoxide (DLCO)	Randomization to 12 months	percent change	MEAN
SECONDARY	Total Number of Respiratory Infections	Randomization to up to 35 months	respiratory infections	NUMBER
SECONDARY	Change in UCSD-Shortness of Breath Questionnaire	Randomization to 12 months	Scores on a scale	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality	Antimicrobial Therapy Plus Standard of Care	52	Participants
Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality	Standard of Care	56	Participants
Number of Participants With Death From Any Cause	Antimicrobial Therapy Plus Standard of Care	37	Participants
Number of Participants With Death From Any Cause	Standard of Care	37	Participants
Number of Participants With First Non-elective, Respiratory Hospitalization	Antimicrobial Therapy Plus Standard of Care	36	Participants
Number of Participants With First Non-elective, Respiratory Hospitalization	Standard of Care	31	Participants
Number of Participants With First Non-elective, All-cause Hospitalization	Antimicrobial Therapy Plus Standard of Care	54	Participants
Number of Participants With First Non-elective, All-cause Hospitalization	Standard of Care	47	Participants
Total Number of Non-elective Respiratory Hospitalizations	Antimicrobial Therapy Plus Standard of Care	55	hospitalizations
Total Number of Non-elective Respiratory Hospitalizations	Standard of Care	43	hospitalizations

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Antimicrobial Therapy Plus Standard of Care	254
Overall Study	STARTED	Standard of Care	259
Overall Study	COMPLETED	Antimicrobial Therapy Plus Standard of Care	169
Overall Study	COMPLETED	Standard of Care	180
Overall Study	NOT COMPLETED	Antimicrobial Therapy Plus Standard of Care	85
Overall Study	NOT COMPLETED	Standard of Care	79

Source ClinicalTrials.gov

Adverse events58

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Arrhythmia	Cardiac disorders	Antimicrobial Therapy Plus Standard of Care	2	254	2
other	Arrhythmia	Cardiac disorders	Standard of Care	5	259	5
other	Vomiting	Gastrointestinal disorders	Antimicrobial Therapy Plus Standard of Care	12	254	14
other	Vomiting	Gastrointestinal disorders	Standard of Care	2	259	2
other	Hyperkalemia	Metabolism and nutrition disorders	Antimicrobial Therapy Plus Standard of Care	10	254	11
other	Hyperkalemia	Metabolism and nutrition disorders	Standard of Care	2	259	2
other	Rash	Skin and subcutaneous tissue disorders	Antimicrobial Therapy Plus Standard of Care	17	254	22
other	Rash	Skin and subcutaneous tissue disorders	Standard of Care	0	259	0
other	Diarrhea	Gastrointestinal disorders	Antimicrobial Therapy Plus Standard of Care	26	254	29
other	Diarrhea	Gastrointestinal disorders	Standard of Care	8	259	8

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Antimicrobial Therapy Plus Standard of Care	37	254
Total, all-cause mortality	Standard of Care	37	259
Total, other adverse events	Antimicrobial Therapy Plus Standard of Care	62	254
Total, other adverse events	Standard of Care	23	259
Total, serious adverse events	Antimicrobial Therapy Plus Standard of Care	71	254
Total, serious adverse events	Standard of Care	65	259

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32164673	DERIVED	PubMed
33974018	DERIVED	PubMed
38030064	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01HL128954	Network Management Core (NEMO) for the Pulmonary Trials Cooperative (PTC)	WISNIEWSKI, STEPHEN R; SCIURBA, FRANK	UNIVERSITY OF PITTSBURGH AT PITTSBURGH	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2015 to 2019

Source NIH RePORTER

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Antimicrobial Therapy Plus Standard of Care vs Standard of Care: Number of Participants With Death From Any Cause	Trial comparisons
Antimicrobial Therapy Plus Standard of Care vs Standard of Care: Number of Participants With First Non-elective, Respiratory Hospitalization or All-cause Mortality	Trial comparisons
Antimicrobial Therapy Plus Standard of Care vs Standard of Care: deaths from any cause	Trial comparisons
Antimicrobial Therapy Plus Standard of Care vs Standard of Care: Number of Participants With First Non-elective, Respiratory Hospitalization	Trial comparisons
Antimicrobial Therapy Plus Standard of Care vs Standard of Care: Number of Participants With First Non-elective, All-cause Hospitalization	Trial comparisons
Antimicrobial Therapy Plus Standard of Care vs Standard of Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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