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CleanUP IPF for the Pulmonary Trials Cooperative

NCT02759120 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 513

Last updated 2021-04-08

Study results available
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Summary

The purpose of this study is to compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF).

Conditions

Interventions

DRUG

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

OTHER

No Intervention: Standard of Care

Standard of care

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Fernando Martinez, MD, MS · Weill Cornell Medical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-22
Primary Completion
2020-03-16
Completion
2020-03-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02759120 on ClinicalTrials.gov