NCT01777737 (TriSulfa-FPI) is a Phase 3 clinical trial of Cotrimoxazole in Idiopathic Pulmonary Fibrosis, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.

Who is sponsoring NCT01777737?

NCT01777737 is sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.

What drugs are being tested in NCT01777737?

Interventions in NCT01777737: Cotrimoxazole, Placebo.

What condition does NCT01777737 study?

NCT01777737 studies Idiopathic Pulmonary Fibrosis.

Is NCT01777737 still recruiting?

NCT01777737 is currently terminated. Last updated 14 November 2017.

Last reviewed 2017-11-14 · How we verify

NCT01777737: TriSulfa-FPI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole

Terminated Phase 3 Last updated 14 November 2017

What this trial tests

Phase 3 trial testing Cotrimoxazole in Idiopathic Pulmonary Fibrosis in 3 participants. Terminated before completion.

Timeline

25 November 2013

Primary endpoint
5 November 2015

5 November 2015

Quick facts

Lead sponsor	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	3
Start date	25 November 2013
Primary completion	5 November 2015
Estimated completion	5 November 2015
Sites	1 location across Spain

Drugs / interventions tested

Cotrimoxazole — full drug profile →
Placebo

Conditions studied

Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla — full company profile →

Who can join

Adults 18 to 80, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

First study to test the validity of the treatment of idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with cotrimoxazole. Cotrimoxazole may improve the clinical course of the disease through eradication of Pneumocystis jiroveci colonization and other mechanisms as inhibiting the activation of alveolar macrophages and producing alterations in the surfactant system which favours the persistent activation of the inflammatory response and the development of pulmonary fibrosis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The Role of Infection in Interstitial Lung Diseases: A Review.
Azadeh N, Limper AH, Carmona EM, Ryu JH. · · 2017 · cited 85× · PMID 28400116 · DOI 10.1016/j.chest.2017.03.033
Regulatory Immune Cells in Idiopathic Pulmonary Fibrosis: Friends or Foes?
van Geffen C, Deißler A, Quante M, Renz H, et al · · 2021 · cited 65× · PMID 33995390 · DOI 10.3389/fimmu.2021.663203
Emerging delivery approaches for targeted pulmonary fibrosis treatment.
Diwan R, Bhatt HN, Beaven E, Nurunnabi M. · · 2024 · cited 52× · PMID 38065244 · DOI 10.1016/j.addr.2023.115147
Targeted Therapy for Idiopathic Pulmonary Fibrosis: Where To Now?
Rangarajan S, Locy ML, Luckhardt TR, Thannickal VJ. · · 2016 · cited 41× · PMID 26729185 · DOI 10.1007/s40265-015-0523-6
Therapeutic Approach to Adult Fibrotic Lung Diseases.
Adegunsoye A, Strek ME. · · 2016 · cited 31× · PMID 27521738 · DOI 10.1016/j.chest.2016.07.027
Modulating NLRP3 Inflammasomes in Idiopathic Pulmonary Fibrosis: A Comprehensive Review on Flavonoid-Based Interventions.
Vithalkar MP, Pradhan S, Sandra KS, Bharath HB, et al · · 2025 · cited 6× · PMID 39966334 · DOI 10.1007/s12013-025-01696-4
Persistent microbial infections and idiopathic pulmonary fibrosis - an insight into <i>non-typeable Haemophilus influenza</i> pathogenesis.
Shadid A, Rich HE, DeVaughn H, Domozhirov A, et al · · 2024 · cited 3× · PMID 39760094 · DOI 10.3389/fcimb.2024.1479801
The effect of additional antimicrobial therapy on the outcomes of patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis.
Chen CY, Chen CH, Wang CY, Lai CC, et al · · 2021 · cited 3× · PMID 34526011 · DOI 10.1186/s12931-021-01839-0

Verify or expand the search:

Other trials of Cotrimoxazole

Trials testing the same drug.

NCT04985110 — Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo Hospital · Phase 2 · unknown
NCT03187834 — Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso · Phase 4 · completed
NCT03087890 — Impact of Cotrimoxazole Use in Immunocompetent HIV Patients on Carriage of Antimicrobial Resistant Bacteria · Phase 4 · completed

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Currently open trials in the same condition.

NCT05988463 — Dose-Escalation Study of Artesunate Patients With IPF · Phase 1 · recruiting
NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in · Phase 2 · recruiting
NCT07407543 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Cauc · Phase 1 · recruiting
NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2 · recruiting
NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o · Phase 1 · recruiting

Other Fundación Pública Andaluza para la gestión de la Investigación en Sevilla trials

Trials by the same sponsor.

NCT05225961 — ATILA Project: Aspirin Versus Tirofiban in Endovascular Treatment for Patients With Acute Ischemic Stroke Due to Tandem · Phase 4 · completed
NCT07521969 — Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial. · NA · recruiting
NCT07153406 — Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients · Phase 3 · not yet recruiting
NCT07353424 — A Multicenter Randomized Clinical Trial Compared With Standard Clinical Practice to Evaluate the Efficacy of a Polypheno · NA · recruiting
NCT06602310 — Utility of Preanestes@s2.0, a Web Based Application for Preoperative Assessment. · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01777737 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Last refreshed: 14 November 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01777737.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing